Trial of Cisplatin Plus Radiation Followed by Carbo and Taxol Vs. Sandwich Therapy of Carbo and Taxol Followed Radiation Then Further Carbo and Taxol

NCT ID: NCT02501954

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2023-11-30

Brief Summary

To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.

Detailed Description

To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence (increases recurrence-free survival) when compared to sandwich therapy (control arm).

To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (increases survival) when compared to sandwich therapy (control arm).

To compare the regimens with respect to tolerability and acute and late adverse effects of therapy.

Conditions

Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen I

Cisplatin 50 mg/m2 IV Days 1 and 29 plus Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Given IV

Carboplatin

Intervention Type: DRUG

Given IV

Paclitaxel

Intervention Type: DRUG

Given IV

Radiation Therapy

Intervention Type: RADIATION

Undergo Radiation Therapy

Regimen II

Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles

Group Type: ACTIVE_COMPARATOR

Carboplatin

Intervention Type: DRUG

Given IV

Paclitaxel

Intervention Type: DRUG

Given IV

Radiation Therapy

Intervention Type: RADIATION

Undergo Radiation Therapy

Interventions

Cisplatin

Given IV

Intervention Type: DRUG

Carboplatin

Given IV

Intervention Type: DRUG

Paclitaxel

Given IV

Intervention Type: DRUG

Radiation Therapy

Undergo Radiation Therapy

Intervention Type: RADIATION

Other Intervention Names

Platinol; Paraplatin; Taxol; RT; Irradiation

Eligibility Criteria

Inclusion Criteria

• All patients with Surgical Stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria, including clear cell and serous papillary and undifferentiated carcinomas.
• Surgical Stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement.
• Surgical Stage IVA includes patients with bladder or bowel mucosal involvement, but no spread outside the pelvis.
• Patients with FIGO 2009 surgical Stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology.
• Surgery must have included a hysterectomy and bilateral salpingooophorectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional.
• Patients with a GOG Performance Status of 0, 1, or 2.
• Patients with adequate organ function, reflected by the following parameters:

WBC ≥ 3000/mcl Absolute neutrophil count (ANC) ≥ 1500/mcl Platelet count ≥ 100,000/mcl SGOT, SGPT, and alkaline phosphatase ≤ 2.5 X upper limit of normal (ULN) Bilirubin ≤ 1.5 X ULN Creatinine ≤ institutional ULN

• Patients must be 18 years of age or older.
• Entry into the study is limited to no more than 8 weeks from the date of surgery.

Exclusion Criteria

• Patients with carcinosarcoma.
• Patients with recurrent endometrial cancer.
• Patients with residual tumor after surgery (any single site) exceeding 1 cm in maximum dimension.
• Patients who have had pelvic or abdominal radiation therapy.
• Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma.
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
• Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy.
• Patients with an estimated survival of less than three months.
• Patients with FIGO 2009 Stage IVB endometrial cancer.
• Patients with parenchymal liver metastases.
• Patients who have received prior chemotherapy for endometrial cancer.
• Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's Cancer Care Associates, LLC

OTHER

Sponsor Role: lead

Responsible Party

Joyce N. Barlin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joyce N Barlin, MD

Role: PRINCIPAL_INVESTIGATOR

Women's Cancer Care Associates, LLC

Locations

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Munson Health Care

Traverse City, Michigan, United States

Atlantic Health

Morristown, New Jersey, United States

Women's Cancer Care Associates, LLC

Albany, New York, United States

The Ohio State University

Columbus, Ohio, United States

Gunderson Lutheran Medical Foundation

La Crosse, Wisconsin, United States

CHUM Hopital Notre-Dame

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

15-07

Identifier Type: -

Identifier Source: org_study_id