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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00600 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000521453 | |||
| ACRIN 6671 | |||
| GOG-0233/ACRIN 6671 | |||
| GOG-0233-ACRIN 6671 | Other Identifier | NRG Oncology | |
| GOG-0233 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| NRG Oncology | OTHER |
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.
PRIMARY OBJECTIVES:
I. Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to abdominal (common iliac, para-aortic, and paracaval) lymph nodes in patients with locoregionally advanced cervical carcinoma.
II. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to retroperitoneal abdominal lymph nodes in patients with high-risk endometrial cancer.
SECONDARY OBJECTIVES:
I. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes and pelvic and abdominal lymph nodes combined in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
II. Compare the additive diagnostic value of CT fusion (PET/CT scan) vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes in these patients.
III. Compare the diagnostic sensitivity and specificity of PET/CT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic, abdominal, and combined lymph nodes in these patients.
IV. Compare the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis, in these patients.
V. Determine the percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning.
VI. Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer.
VII. Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer.
VIII. Determine the cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer.
IX. Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
X. Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRI's in a subset of forty patients.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.
After completion of study therapy, patients are followed at 6 weeks, 6 months, every 3 months for 2 years, and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (diagnostic scans, surgery, chemotherapy, radiation) | Experimental | Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fludeoxyglucose F 18 | Radiation | Undergo FDG PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers. | Before surgery (FDG-PET-CT) and after surgery (pathology) |
| The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Measure | Description | Time Frame |
|---|---|---|
| The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity. | Before surgery (DCT) and after surgery (pathology) |
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Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Invasive carcinoma of the cervix meeting all of the following criteria:
High-risk endometrial carcinoma meeting 1 of the following criteria:
Under consideration for chemoradiotherapy (patients with cervical cancer)
Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling
No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment
No known metastases to the lungs or scalene lymph nodes
No metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis
Participants must be enrolled at an American College of Radiology Imaging Network (ACRIN)-affiliated institution that is accredited by Gynecologic Oncology Group (GOG)
GOG performance status 0-2
Creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be > 60 mL/min; there is no lower limit of normal for serum creatinine for this protocol
Ferritin levels =< 600 ng/mL OR saturation of transferrin level =< 50%
Not pregnant or nursing
Negative pregnancy test
No patients weighing greater than that allowable by the PET/CT scanner
No renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of the lymphadenectomy
No history of anaphylactic or life-threatening allergic reactions to any contrast media
No other invasive malignancies within the past 5 years with the exception of nonmelanoma skin cancer
No contraindication to MRI (e.g., severe claustrophobia, pacemaker, aneurysm clips, defibrillators, or other institutional contraindication to MRI)
No history of allergic reactions attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations)
No immunodeficiencies that would predispose patient to specific or nonspecific mediator release
No history of cirrhosis
No poorly controlled, insulin-dependent diabetes (i.e., fasting blood glucose level > 200 mg/dL)
No prior pelvic or abdominal lymphadenectomy
No prior pelvic radiotherapy
No prior anticancer therapy that would contraindicate study participation
No ferumoxides within the past 2 weeks
No investigational agents within the past 30 days
No other concurrent investigational agents
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| Name | Affiliation | Role |
|---|---|---|
| Mostafa Atri | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States | ||
| University of California at Los Angeles Health System |
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The study was activated on 9/24/2007. Combidex MRI was discontinued on 11/09/2009 due to lack of study drug. GOG 0233 (NCT 00416455) closed to accrual on 6/21/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervical Cancer Patients | PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| positron emission tomography | Procedure | Undergo FDG PET/CT |
|
|
| computed tomography | Procedure | Undergo FDG PET/CT |
|
|
| ferumoxtran-10 | Drug | Undergo femoxtran-10 MRI |
|
|
| magnetic resonance imaging | Procedure | Undergo femoxtran-10 MRI |
|
|
| diagnostic lymphadenectomy | Procedure | Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy |
|
| lymph node biopsy | Procedure | Undergo pelvic and abdominal lymph node biopsy |
|
|
| The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers. | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0. | During surgery and up to 30 days after surgery. |
| Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients | Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy | Within 4 weeks from PET/CT |
| Cause of Interruption in Radiation Therapy in Cervical Cancer Patients | Number of cervical cancer patients with reasons of interruption in radiation therapy | Within 6 weeks after surgery |
| Los Angeles |
| California |
| 90095 |
| United States |
| Olive View-University of California Los Angeles Medical Center | Sylmar | California | 91342 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Georgia Regents University Medical Center | Augusta | Georgia | 30912 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| UMDNJ - New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| Island Gynecologic Oncology | Brightwaters | New York | 11718 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Weill Medical College of Cornell University | New York | New York | 10065 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Cancer Center -The Plaza | Portland | Oregon | 97213 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| CHUQ - Pavilion Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Kagoshima City Hospital | Kagoshima City, Kagoshima | 892-8580 | Japan |
| Saitama Medical University International Medical Center | Saitama | 350-1298 | Japan |
| Keimyung University-Dongsan Medical Center | Jung-Ku | Daegu | 700-712 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Gangnam Severance Hospital | Seoul | 135-720 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Korea Cancer Center Hospital | Seoul | 139-706 | South Korea |
| Endometrial Cancer Patients |
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan |
| COMPLETED |
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| NOT COMPLETED |
|
|
Adequate imaging and pathologically eligible patients (N =360)
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Cancer Patients | PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan |
| BG001 | Endometrial Cancer Patients | PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers. | Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET-CT) and after surgery (pathology) |
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|
| ||||||||||||||||||||||||||||
| Primary | The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers. | Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients. | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| ||||||||||||||||||||||||||||||
| Secondary | The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity. | Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients. | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (DCT) and after surgery (pathology) |
| ||||||||||||||||||||||||||||||
| Secondary | The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity. | Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| ||||||||||||||||||||||||||||||
| Secondary | The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity. | Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients | Posted | Mean | 95% Confidence Interval | Percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
| ||||||||||||||||||||||||||||||
| Secondary | The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity. | Cervical cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients. | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
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| Secondary | Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers. | Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
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| Secondary | Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers. | Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
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| Secondary | Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers. | Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
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| Secondary | Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers. | Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
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| Secondary | Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers. | Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
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| Secondary | Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers. | Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients. | Posted | Mean | 95% Confidence Interval | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
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| Secondary | Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes | Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients | Posted | Number | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
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| Secondary | Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node | Particpants with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients | Posted | Number | percentage of participants | Before surgery (FDG-PET/CT) and after surgery (pathology) |
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| Secondary | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0. | All loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy | Posted | Count of Participants | Participants | No | During surgery and up to 30 days after surgery. |
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| Secondary | Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients | Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy | All Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy and the reason they experienced a delay in the initiation of chemo-radiation | Posted | Count of Participants | Participants | Within 4 weeks from PET/CT |
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| Secondary | Cause of Interruption in Radiation Therapy in Cervical Cancer Patients | Number of cervical cancer patients with reasons of interruption in radiation therapy | Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy who experienced an interruption in radiation therapy | Posted | Count of Participants | Participants | Within 6 weeks after surgery |
|
|
All Adverse Events (AEs) occurring within 30 days of surgery are reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervical Cancer Patients | PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan | 17 | 169 | 108 | 169 | ||
| EG001 | Endometrial Cancer Patients | PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan | 19 | 215 | 132 | 215 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conduction Abnml: Asystole | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| S/N Arrhythmia: Atrial Flutter | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death No Ctcae Term - Death Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fistula, Gi - Colon/Cecum/Appendix | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gi - Colon | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gi - Small Bowel Nos | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gu - Vagina | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage With Surgery | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Abdomen Nos | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/Bleeding - Other | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Lung (Pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection - Other | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Pelvis Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Lymphatic | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Small Bowel Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Abdomen Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Skin (Cellulitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphocele | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Gallbladder | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leak, Gu - Ureter | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| 2nd Mal: Poss. Related To Cancer Rx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intra-Op Injury: Other | Surgical and medical procedures | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tumor Flare | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/Embolism (Vascular Access-Related) | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood/Bone Marrow - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| S/N Arrhythmia: Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Conduction Abnml: Asystole | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| S/N Arrhythmia: Atrial Flutter | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| S/N Arrhythmia: Sinus Tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| S/N Arrhythmia: Sinus Bradycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inr | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Coagulopathy - Other | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight Gain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight Loss | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rigors/Chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death No Ctcae Term - Disease Progression Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death No Ctcae Term - Death Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hair Loss/Alopecia (Scalp Or Body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Wound Complication, Non-Infectious | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot Flashes | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fistula, Gi - Colon/Cecum/Appendix | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leak, Gi - Leak Nos | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fistula, Gi - Jejunum | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Distention | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gi - Small Bowel Nos | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gi - Jejunum | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gu - Vagina | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Upper Gi Nos | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Abdomen Nos | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Petechiae | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/Bleeding - Other | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Lung (Pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Colon | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection - Other | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis, Infectious (Eg.C. Difficile) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Pelvis Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Upper Airway Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Bronchus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Abdomen Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Skin (Cellulitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Bladder | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphatics - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphocele | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: Viscera | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: Trunk/Genital | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: Limb | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chyle Or Lymph Leakage | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ast | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Metabolic/Laboratory - Other | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alt | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alkaline Phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal/St: Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Soft Tissue Necrosis - Abdomen | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle Weakness - Whole Body/Generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle Weakness - Extremity-Lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mental Status | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood Alteration - Depression | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood Alteration - Anxiety | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuropathy-Sensory | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuropathy-Motor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Urethra | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Pelvis | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Breast | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Vagina | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Chest /Thorax Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Chest Wall | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Head/Headache | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Extremity-Limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Back | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Joint | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Gallbladder | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Skin | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Muscle | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Anus | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema, Larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal/Genitourinary - Other | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leak, Gu - Ureter | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gu - Ureter | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Incontinence, Urinary | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder Spasm | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary Frequency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intra-Op Injury: Vein-Inferior Vena Cava | Surgical and medical procedures | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intra-Op Injury: Bladder | Surgical and medical procedures | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flu-Like Syndrome | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/Embolism (Vascular Access-Related) | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Relatively small number of patients with abdominal metastasis in both cervical and endometrial cancer cohorts
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela M. Kuras, Associate Director of Data Management | NRG Oncology Statistics and Data Management Center | 716-845-7733 | kurasa@nrgoncology.org |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| C097921 | ferumoxtran-10 |
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
Not provided
Not provided
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