- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041027
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer
A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Albert Einstein College of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Histologically-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria:
- Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IAG3) with lymphovascular space involvement;
- Surgical stage I disease with >= 50% myometrial invasion and grade 2 or 3 tumor (IBG2, IBG3);
- Any surgical stage II disease (II);
- Any surgical stage III disease (IIIA, IIIB, IIIC); and
- Any surgical stage IV disease with no residual macroscopic tumor
- 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:
- Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) > 2.5 times the institutional upper limit of normal
- Total serum bilirubin > 1.5 mg/dl
- History of chronic or active hepatitis
- Serum creatinine > 2.0 mg/dl
- Platelets < 100,000/mm^3
- Absolute neutrophil count (ANC) < 1500/mm^3
- Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)
- Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
- Patient with any prior chemotherapy or radiotherapy for pelvic malignancy
- Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
- Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
Correlative studies
Given IV
Given IV
Other Names:
Undergo EBRT
Other Names:
Undergo HDR brachytherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expression Levels of IGF-1
Time Frame: Up to 5 years
|
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
Time Frame: Up to 5 years
|
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
Time Frame: Up to 5 years
|
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
Time Frame: Up to 5 years
|
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
Time Frame: Up to 5 years
|
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
Time Frame: Up to 5 years
|
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
Time Frame: Up to 5 years
|
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
Time Frame: Up to 5 years
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dennis Yi-Shin Kuo, Albert Einstein College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Endometrial Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- 08-03-060 (Other Identifier: Albert Einstein College of Medicine)
- P30CA013330 (U.S. NIH Grant/Contract)
- NCI-2013-01224 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 07-062
- NCI-2012-00458
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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