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| ID | Type | Description | Link |
|---|---|---|---|
| 1601638414 | Other Identifier | Indiana University IRB |
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This is a single center, single arm unblinded prospective study of the safety of pancreatic stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline resectable, or recurrent pancreatic/periampullary cancers who have previously undergone treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated radiation treatment, or any combination of these therapies.
Primary Objective
• To estimate rates of acute (within 3 months of treatment) grade 3 or greater gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers who have previously received other treatment.
Secondary Objectives
Patients will receive 5 fractions of 5 gray (Gy) or 6.6 Gy delivered over a five-day period based on whether or not they have received prior radiation therapy to the pancreatic region. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week. Initial patient positioning will be based on volumetric kV (cone-beam computerized tomography) imaging with shifts to bony anatomy as appropriate. Orthogonal kV/MV or kV/kV projection imaging will be used to verify the location of the fiducials prior to delivery of the first treatment beam. A secondary shift based on the location of fiducials may be utilized, as indicated by the position of the fiducials. For free-breathing treatments, kV fluoroscopic images should be obtained to confirm the anticipated position of these fiducials during the entire respiratory cycle. Active monitoring of treatment delivery accuracy will be accomplished using kV and/or MV projection imaging, either immediately before or during all (or a subset of) treatment fields. Patient-specific dosimetric quality assurance (QA) will be performed as per standard practice in the Department of Radiation Oncology, Indiana University School of Medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation | Experimental | Patients will receive 5 fractions of 5 Gy or 6.6 Gy (dose depending upon whether or not they have received prior radiation therapy to the pancreatic region) delivered over a five-day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Measures include the percentage of patients who experienced the toxicity with a grade of 3 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0. | Up to 90 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage) | Measures include the percentage of patients who experienced the toxicity with a grade of 2 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0. |
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Inclusion Criteria
Age >18 years.
Karnofsky Performance Status >70%
Histologically confirmed adenocarcinoma of the pancreas or ampulla of Vater; at least the majority of the histopathologic specimen must be identified as adenocarcinoma as opposed to another histologic subtype. In patients with a diagnosis of recurrent disease (based on radiographic progression and/or rising CA19-9 levels) and a history of a biopsy-proven adenocarcinoma of the pancreas or the ampulla of Vater, repeat biopsy of the recurrence site is not required for participation of the trial.
Pancreatic or periampullary tumors must be less than 8.0 cm in greatest axial dimension at the time of treatment planning.
Patients who have been treated with any combination of surgical resection and neoadjuvant/adjuvant conventional chemoradiation therapy for resectable disease or conventional chemoradiation as definitive treatment for unresectable or borderline resectable disease are eligible for the study, provided that at least 180 days have elapsed since completing any previous radiation treatment. Patients who have been receiving continued chemotherapy following their initial radiation treatment are eligible regardless of when the most recent chemotherapy was received. Those patients who have received prior radiation therapy will constitute Cohort A and will receive stereotactic body radiation (SBRT) as 5 gray (Gy) x 5.
Patients who have not previously undergone radiation therapy can have a history of treatment with either chemotherapy (for unresectable/borderline resectable disease) or any combination of surgery and chemotherapy (for resectable disease). Patients with no history of prior radiation treatment will constitute Cohort B and will receive SBRT as 6.6 Gy x 5. Please note that patients must have received at least two cycles of chemotherapy (with selection of drugs at the discretion of the treating oncologist) before SBRT treatment on protocol.
Acceptable organ and marrow function as defined below (within 2 weeks prior to radiotherapy):
Ability to understand and the willingness to sign a written informed consent document.
Life expectancy > 3 months.
Radio-opaque markers must be present within the tumor bed. In patients who have undergone surgical resection, radio-opaque surgical clips within the tumor bed can be used as fiducials. Patients without surgical clips in the tumor bed must be able to have fiducials placed endoscopically, laparoscopically, or through a CT- or ultrasound-guided technique. If not, the tumor must be posterior and adjacent to the aorta, and treatment will only be permitted at the discretion of the Principal Investigator.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert Miller, MD | Indiana University School of Medicine, Indiana University Simon Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Health Melvin and Bren Simon Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. |
| FG001 | Cohort B | Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. |
| BG001 | Cohort B | Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Measures include the percentage of patients who experienced the toxicity with a grade of 3 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0. | Includes all patients in cohorts A and B who met eligibility criteria for primary outcome measure. | Posted | Number | 90% Confidence Interval | percentage of participants | Up to 90 days after treatment |
|
7 years from start of treatment
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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 | Cohort A | Patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Miller | IndianaU | 317-944-1317 | millro@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2024 | Jun 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 90 or more days after treatment, up to 7 years |
| Overall Survival | This measure reports the overall survival probability from the Kaplan Meier method. The survival time was calculated from the date of treatment start to the date of death and patients who did not expire were censored at their last date known alive. | 1 year after treatment |
| Progression-Free Survival | This measure represents the progression-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of progression or death. Patients who did not experience progression were censored at their last known date alive. | 1 year after treatment |
| Metastasis-Free Survival | This represents the metastasis-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of metastasis or death. Patients who did not experience metastasis or death were censored at their last known date alive. | 1 year after treatment |
| Wong-Baker FACES Pain Rating Score | Measured with the Wong-Baker FACES 0-10 scale where higher scores indicate more pain. Patients self-reported the score before (baseline), during (weeks 1 and 2), and after (1 and 3 months) treatment. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1 and 3) were averaged to create a composite "after treatment" score. | Baseline (before treatment), Week 1 (during treatment), Week 2 (during treatment), Month 1 (after treatment), and Month 3 (after treatment) |
| Quality of Life Scores - Global Health Status / Quality of Life | Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Global Health Status / Quality of Life composite score was calculated by combining the scores for questions 29 and 30 and calculating Score = {(RS -1) range}×100. Responses for questions 29 and 30 ranged from 1 to 7 with 1 indicating "Very Poor" and 7 indicating "Excellent". Higher scores indicate a better quality of life with a minimum composite score of 0 and a maximum composite score of 100. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite "after treatment" score. | Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment) |
| Quality of Life Scores - Functional Scales | Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Functional scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {1 - ((RS -1) / range)}×100. The response options for each question were "1-Not at all", "2-A little", "3-Quite a bit", and "4-Very Much". Higher scores indicate a high/healthy level of functioning with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite "after treatment" score. | Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment) |
| Quality of Life Scores - Symptom Scales | Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Symptom scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {(RS -1) range}×100. The response options for each question were "1-Not at all", "2-A little", "3-Quite a bit", and "4-Very Much". Higher scores indicate a high level of symptomatology / problems with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite "after treatment" score. | Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment) |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage) | Measures include the percentage of patients who experienced the toxicity with a grade of 2 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0. | Includes those patients who were determined to be eligible for the secondary outcome measures. | Posted | Number | 90% Confidence Interval | percentage of participants | 90 or more days after treatment, up to 7 years |
|
|
|
| Secondary | Overall Survival | This measure reports the overall survival probability from the Kaplan Meier method. The survival time was calculated from the date of treatment start to the date of death and patients who did not expire were censored at their last date known alive. | Includes patients in Cohort B who were considered eligible for the outcome analyses. | Posted | Number | 90% Confidence Interval | survival probability | 1 year after treatment |
|
|
|
| Secondary | Progression-Free Survival | This measure represents the progression-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of progression or death. Patients who did not experience progression were censored at their last known date alive. | Includes patients in cohort B who were determined to be eligible for the secondary objectives. | Posted | Number | 90% Confidence Interval | survival probability | 1 year after treatment |
|
|
|
| Secondary | Metastasis-Free Survival | This represents the metastasis-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of metastasis or death. Patients who did not experience metastasis or death were censored at their last known date alive. | Includes patients in Cohort B who were determined to be eligible for the secondary outcomes analyses. | Posted | Number | 90% Confidence Interval | survival probability | 1 year after treatment |
|
|
|
| Secondary | Wong-Baker FACES Pain Rating Score | Measured with the Wong-Baker FACES 0-10 scale where higher scores indicate more pain. Patients self-reported the score before (baseline), during (weeks 1 and 2), and after (1 and 3 months) treatment. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1 and 3) were averaged to create a composite "after treatment" score. | Includes all patients who were determined to be eligible for the secondary outcomes. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (before treatment), Week 1 (during treatment), Week 2 (during treatment), Month 1 (after treatment), and Month 3 (after treatment) |
|
|
|
|
| Secondary | Quality of Life Scores - Global Health Status / Quality of Life | Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Global Health Status / Quality of Life composite score was calculated by combining the scores for questions 29 and 30 and calculating Score = {(RS -1) range}×100. Responses for questions 29 and 30 ranged from 1 to 7 with 1 indicating "Very Poor" and 7 indicating "Excellent". Higher scores indicate a better quality of life with a minimum composite score of 0 and a maximum composite score of 100. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite "after treatment" score. | Includes patients who were eligible for the secondary outcomes. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment) |
|
|
|
|
| Secondary | Quality of Life Scores - Functional Scales | Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Functional scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {1 - ((RS -1) / range)}×100. The response options for each question were "1-Not at all", "2-A little", "3-Quite a bit", and "4-Very Much". Higher scores indicate a high/healthy level of functioning with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite "after treatment" score. | Includes patients who were eligible for the secondary outcomes. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment) |
|
|
|
|
| Secondary | Quality of Life Scores - Symptom Scales | Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Symptom scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {(RS -1) range}×100. The response options for each question were "1-Not at all", "2-A little", "3-Quite a bit", and "4-Very Much". Higher scores indicate a high level of symptomatology / problems with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite "after treatment" score. | Includes patients who were eligible for the secondary outcomes. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment) |
|
|
|
|
| 3 |
| 3 |
| 3 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort B | Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5 | 33 | 33 | 33 | 33 | 24 | 33 |
| Hepatobiliary disorders - Other, sp | Hepatobiliary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Biliary tract infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Duodenal infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Esophageal infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Fever | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypothermia | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| INR increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Pain | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Biliary tract infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| CPK increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Chills | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Duodenal obstruction | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Edema limbs | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Esophageal infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Fatigue | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| Fever | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hallucinations | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypothermia | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| INR increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Localized edema | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pain | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
|
| Pancreatic enzymes decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Portal hypertension | Hepatobiliary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Rhinitis infective | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Urine discoloration | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Urine output decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Vasovagal reaction | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Weight gain | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Title | Measurements |
|---|---|
|
| Ulcer |
|
| Diarrhea |
|
| Vomiting |
|
| After Treatment Score |
|
| Global Health Status - During Treatment |
|
|
| Global Health Status - After Treatment |
|
|
| Physical Functioning - During Treatment |
|
|
| Physical Functioning - After Treatment |
|
|
| Role Functioning - Before Treatment |
|
|
| Role Functioning - During Treatment |
|
|
| Role Functioning - After Treatment |
|
|
| Emotional Functioning - Before Treatment |
|
|
| Emotional Functioning - During Treatment |
|
|
| Emotional Functioning - After Treatment |
|
|
| Cognitive Functioning - Before Treatment |
|
|
| Cognitive Functioning - During Treatment |
|
|
| Cognitive Functioning - After Treatment |
|
|
| Social Functioning - Before Treatment |
|
|
| Social Functioning - During Treatment |
|
|
| Social Functioning - After Treatment |
|
|
| The null hypothesis was that there was no difference in composite role functioning composite scores across treatment phase. | Regression, Logistic | 0.789 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite role functioning composite score as the outcome. |
| The null hypothesis was that there was no difference in composite emotional functioning composite scores across treatment phase. | Regression, Logistic | 0.303 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite emotional functioning composite score as the outcome. |
| The null hypothesis was that there was no difference in composite cognitive functioning composite scores across treatment phase. | Regression, Logistic | 0.989 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite cognitive functioning composite score as the outcome. |
| The null hypothesis was that there was no difference in composite social functioning composite scores across treatment phase. | Regression, Logistic | 0.436 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite social functioning composite score as the outcome. |
| Fatigue - During Treatment |
|
|
| Fatigue - After Treatment |
|
|
| Nausea and Vomiting - Before Treatment |
|
|
| Nausea and Vomiting - During Treatment |
|
|
| Nausea and Vomiting - After Treatment |
|
|
| Pain - Before Treatment |
|
|
| Pain - During Treatment |
|
|
| Pain - After Treatment |
|
|
| Dyspnea - Before Treatment |
|
|
| Dyspnea - During Treatment |
|
|
| Dyspnea - After Treatment |
|
|
| Insomnia - Before Treatment |
|
|
| Insomnia - During Treatment |
|
|
| Insomnia - After Treatment |
|
|
| Appetite Loss - Before Treatment |
|
|
| Appetite Loss - During Treatment |
|
|
| Appetite Loss - After Treatment |
|
|
| Constipation - Before Treatment |
|
|
| Constipation - During Treatment |
|
|
| Constipation - After Treatment |
|
|
| Diarrhea - Before Treatment |
|
|
| Diarrhea - During Treatment |
|
|
| Diarrhea - After Treatment |
|
|
| Financial Difficulties - Before Treatment |
|
|
| Financial Difficulties - During Treatment |
|
|
| Financial Difficulties - After Treatment |
|
|
| The null hypothesis was that there was no difference in composite nausea and vomiting symptom scores across treatment phase. | Regression, Logistic | 0.295 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite nausea and vomiting symptom score as the outcome. |
| The null hypothesis was that there was no difference in composite pain symptom scores across treatment phase. | Regression, Logistic | 0.299 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite pain symptom score as the outcome. |
| The null hypothesis was that there was no difference in composite dyspnea symptom scores across treatment phase. | Regression, Logistic | 0.794 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite dyspnea symptom score as the outcome. |
| The null hypothesis was that there was no difference in composite insomnia symptom scores across treatment phase. | Regression, Logistic | 0.450 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite insomnia symptom score as the outcome. |
| The null hypothesis was that there was no difference in composite appetite loss symptom scores across treatment phase. | Regression, Logistic | 0.389 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite appetite loss symptom score as the outcome. |
| The null hypothesis was that there was no difference in composite constipation symptom scores across treatment phase. | Regression, Logistic | The odds of having a higher constipation symptom composite score after treatment were less than during or before treatment. | 0.011 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite constipation symptom score as the outcome. |
| The null hypothesis was that there was no difference in composite diarrhea symptom scores across treatment phase. | Regression, Logistic | 0.101 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite diarrhea symptom score as the outcome. |
| The null hypothesis was that there was no difference in composite financial difficulty symptom scores across treatment phase. | Regression, Logistic | 0.306 | The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model. | Other | Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite financial difficulty symptom score as the outcome. |