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

Primary Purpose

Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage IIIA Uterine Corpus Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cisplatin
Carboplatin
Paclitaxel
Radiation Therapy
Sponsored by
Women's Cancer Care Associates, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Clear Cell Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Greater Baltimore Medical Center
  • Munson Health Care
  • Atlantic Health
  • Women's Cancer Care Associates, LLC
  • The Ohio State University
  • Gunderson Lutheran Medical Foundation
  • CHUM Hopital Notre-Dame

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regimen I

Regimen II

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrence-free survival (RFS)
RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.

Secondary Outcome Measures

Overall survival (OS)
OS assessed by the contact with patient in person or by telephone

Full Information

First Posted
July 9, 2015
Last Updated
May 16, 2023
Sponsor
Women's Cancer Care Associates, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02501954
Brief Title
Trial of Cisplatin Plus Radiation Followed by Carbo and Taxol Vs. Sandwich Therapy of Carbo and Taxol Followed Radiation Then Further Carbo and Taxol
Official Title
Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Sandwich Therapy of Carboplatin and Paclitaxel Followed by Tumor Volume Directed Irradiation Then Further Carboplatin and Paclitaxel
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women's Cancer Care Associates, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regimen I
Arm Type
Experimental
Arm Description
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
Arm Title
Regimen II
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
RT, Irradiation
Intervention Description
Undergo Radiation Therapy
Primary Outcome Measure Information:
Title
Recurrence-free survival (RFS)
Description
RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.
Time Frame
From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS assessed by the contact with patient in person or by telephone
Time Frame
from study entry to death or date of last contact, assessed up to 8 years
Other Pre-specified Outcome Measures:
Title
Incidence of acute and adverse effects as graded by the NCI Common Toxicity Criteria for Adverse Events version (CTCAE) version 4.0
Time Frame
From study entry through completion of study treatment, assessed for 1 year.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce N Barlin, MD
Organizational Affiliation
Women's Cancer Care Associates, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Munson Health Care
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Atlantic Health
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Women's Cancer Care Associates, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Gunderson Lutheran Medical Foundation
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
CHUM Hopital Notre-Dame
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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