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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01224 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 07-062 | |||
| NCI-2012-00458 | |||
| 08-03-060 | Other Identifier | Albert Einstein College of Medicine | |
| P30CA013330 | U.S. NIH Grant/Contract | View source |
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Due to slow accrual. Results from the PORTEC3 the study rendered the hypothesis no longer valid.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in treating patients with high-risk endometrial cancer. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Giving radiation therapy with chemotherapy may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To evaluate progression-free survival. II. To assess and document location of disease recurrence (distant vs local vs both) using this treatment regimen.
II. To evaluate the toxicity of radiation therapy "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with high-risk endometrial cancer.
III. To evaluate the associations of cancer recurrence with tumor tissue expression levels of insulin-like growth factor-I (IGF-I), IGF-II, insulin-like growth factor binding protein 1 (IGFBP-1) and -3, insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor.
OUTLINE:
CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21.
RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo high dose rate (HDR) brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (paclitaxel, carboplatin, radiation therapy) | Experimental | CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21. RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS will be analyzed using standard survival analytic methods, including the Kaplan-Meier approach for estimating the survival distribution. Median time to progression and 95% confidence intervals will be estimated from the Kaplan-Meier curves. | From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Expression Levels of IGF-1 | Associations of PFS with tumor tissue expression levels of IGF-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Up to 5 years |
| Expression Levels of IGF-2 |
Not provided
Inclusion Criteria:
Histologically-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria:
Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard Gynecologic Oncology Group (GOG) criteria
Eastern Cooperative Oncology Group (ECOG) performance status of < 2
Written voluntary informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Yi-Shin Kuo | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
40 participants were recruited. Of the 40 participants, 1 participant was not consented and 8 participants screen failed. 31 participants were enrolled and randomized into the study.
31 participants were enrolled into the study between 1/16/2009 (date the first participant was enrolled) and 6/3/2019 (date final participant was enrolled)
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Paclitaxel, Carboplatin, Radiation Therapy) | CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21. RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15. Paclitaxel: Given IV Carboplatin: Given IV Internal Radiation Therapy: Undergo HDR brachytherapy External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 22, 2019 |
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| Carboplatin | Drug | Given IV |
|
| Internal Radiation Therapy | Radiation | Undergo HDR brachytherapy |
|
|
| External Beam Radiation Therapy | Radiation | Undergo EBRT |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
Associations of PFS with tumor tissue expression levels of IGF-2 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. |
| Up to 5 years |
| Expression Levels of IGFBP-1 | Associations of PFS with tumor tissue expression levels of IGFBP-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Up to 5 years |
| Expression Levels of IGFBP-3 | Associations of PFS with tumor tissue expression levels of IGFBP-3 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Up to 5 years |
| Expression Levels of Insulin Receptor | Associations of PFS with tumor tissue expression levels of insulin receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Up to 5 years |
| Expression Levels of IGF-1 Receptor | Associations of PFS with tumor tissue expression levels of IGF-1 receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Up to 5 years |
| Expression Levels of Estrogen Receptor | Associations of PFS with tumor tissue expression levels of estrogen receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Up to 5 years |
| Expression Levels of Progesterone Receptor | Associations of PFS with tumor tissue expression levels of progesterone receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Up to 5 years |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Paclitaxel, Carboplatin, Radiation Therapy) | CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21. RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15. Paclitaxel: Given IV Carboplatin: Given IV Internal Radiation Therapy: Undergo HDR brachytherapy External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Progression-free Survival (PFS) | PFS will be analyzed using standard survival analytic methods, including the Kaplan-Meier approach for estimating the survival distribution. Median time to progression and 95% confidence intervals will be estimated from the Kaplan-Meier curves. | PFS data was not collected and analyzed. | Posted | From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years |
|
| |||||||||||||||||||
| Secondary | Expression Levels of IGF-1 | Associations of PFS with tumor tissue expression levels of IGF-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | IGF-1 expression data was not collected and analyzed. | Posted | Up to 5 years |
|
| |||||||||||||||||||
| Secondary | Expression Levels of IGF-2 | Associations of PFS with tumor tissue expression levels of IGF-2 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | IGF-2 expression data was not collected and analyzed. | Posted | Up to 5 years |
|
| |||||||||||||||||||
| Secondary | Expression Levels of IGFBP-1 | Associations of PFS with tumor tissue expression levels of IGFBP-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | IGFBP-1 expression data was not collected and analyzed. | Posted | Up to 5 years |
|
| |||||||||||||||||||
| Secondary | Expression Levels of IGFBP-3 | Associations of PFS with tumor tissue expression levels of IGFBP-3 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | IGFBP-3 expression data was not collected and analyzed. | Posted | Up to 5 years |
|
| |||||||||||||||||||
| Secondary | Expression Levels of Insulin Receptor | Associations of PFS with tumor tissue expression levels of insulin receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Insulin receptor expression data was not collected and analyzed. | Posted | Up to 5 years |
|
| |||||||||||||||||||
| Secondary | Expression Levels of IGF-1 Receptor | Associations of PFS with tumor tissue expression levels of IGF-1 receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | IGF-1 receptor expression data was not collected and analyzed. | Posted | Up to 5 years |
|
| |||||||||||||||||||
| Secondary | Expression Levels of Estrogen Receptor | Associations of PFS with tumor tissue expression levels of estrogen receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Estrogen receptor expression data was not collected and analyzed. | Posted | Up to 5 years |
|
| |||||||||||||||||||
| Secondary | Expression Levels of Progesterone Receptor | Associations of PFS with tumor tissue expression levels of progesterone receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations. | Progesterone receptor expression data was not collected and analyzed. | Posted | Up to 5 years |
|
|
Up to 5 years
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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 | Treatment (Paclitaxel, Carboplatin, Radiation Therapy) | CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21. RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15. Paclitaxel: Given IV Carboplatin: Given IV Internal Radiation Therapy: Undergo HDR brachytherapy External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies | 3 | 31 | 2 | 31 | 5 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Grades 3-4 |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Grade 4 |
|
| Vaginal Hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | Hospitalization for PICC site infection |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| SGOT/SGPT ratio elevated | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Increased ALT | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Leukocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash Acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neuropathy (peripheral) | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ankle Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Breast Pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vulval Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Numbness |
|
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Finger Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Right hand |
|
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal Inflammation | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | Inflammation lead to pain |
|
| Vaginal Irritation | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim term |
|
| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin Discoloration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim term |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim term |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dennis Yi-Shin Kuo | Montefiore Medical Center | 718-405-8086 | dykuo@montefiore.org |
| Aug 4, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D016190 | Carboplatin |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|