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

NCT02501954 | Completed Phase 3

• 1 other identifier: 15-07
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival (RFS)

  RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.

  From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years

Secondary Outcomes (1)

• Overall survival (OS)

  from study entry to death or date of last contact, assessed up to 8 years

Other Outcomes (1)

• Incidence of acute and adverse effects as graded by the NCI Common Toxicity Criteria for Adverse Events version (CTCAE) version 4.0

  From study entry through completion of study treatment, assessed for 1 year.

Study Arms (2)

Regimen I

EXPERIMENTAL

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

Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy

Regimen II

ACTIVE COMPARATOR

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

Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy

Interventions

Cisplatin DRUG

Given IV

Also known as: Platinol

Regimen I

Carboplatin DRUG

Given IV

Also known as: Paraplatin

Regimen I; Regimen II

Paclitaxel DRUG

Given IV

Also known as: Taxol

Regimen I; Regimen II

Radiation Therapy RADIATION

Undergo Radiation Therapy

Also known as: RT, Irradiation

Regimen I; Regimen II

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Cancer Care Associates, LLC: lead

Study Sites (7)

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Munson Health Care

Traverse City, Michigan, 49684, United States

Location

Atlantic Health

Morristown, New Jersey, 07960, United States

Location

Women's Cancer Care Associates, LLC

Albany, New York, 12208, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Gunderson Lutheran Medical Foundation

La Crosse, Wisconsin, 54601, United States

Location

CHUM Hopital Notre-Dame

Montreal, Quebec, H2L4M1, Canada

Location

MeSH Terms

Interventions

Cisplatin; Carboplatin; Paclitaxel; Radiotherapy; Radiation

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics; Physical Phenomena

Study Officials

• Joyce N Barlin, MD

  Women's Cancer Care Associates, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 17, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CA (1); US (6)