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A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

Phase 3
18 Years
Open (Enrolling)
Endometrial Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma



- Compare the recurrence-free survival of patients with stage I-IVA endometrial carcinoma
treated with adjuvant chemoradiotherapy comprising cisplatin and tumor volume-directed
radiotherapy followed by carboplatin and paclitaxel vs carboplatin and paclitaxel


- Compare the overall survival of patients treated with these regimens.

- Compare the acute and late adverse effects of these regimens in these patients.

- Determine the impact of these regimens on patient-reported quality of life during and
for up to 1 year after completion of study treatment.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cisplatin IV on days 1 and 29. Patients also undergo
external-beam radiotherapy once daily, 5 days a week, for 5-6 weeks. Some patients may
then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of
chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on
day 1. Treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.

- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1.
Treatment repeats every 21 days for 6 courses in the absence of disease progression or
unacceptable toxicity.

Patients complete quality-of-life questionnaires at baseline and periodically during study
using the FACT-G Physical and Functional Well-Being, FACT-Endometrial, FACT/GOG Neuropathy,
and FACT-C (items C3 and C5).

After completion of study therapy, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.

Inclusion Criteria


- Histologically confirmed endometrial carcinoma, including the following cell types:

- Clear cell carcinoma

- Serous papillary carcinoma

- Undifferentiated carcinoma

- Surgical stage III or IVA disease per FIGO 2009 staging criteria

- Surgical stage III disease includes positive adnexa, tumor invading the serosa,
positive pelvic and/or para-aortic nodes, or vaginal involvement

- Surgical stage IVA disease includes bladder or bowel mucosal involvement, but no
spread outside the pelvis

- Surgical stage I or II endometrial clear cell or serous papillary carcinoma with
positive peritoneal cytology per FIGO 2009 staging criteria

- Has undergone optimal surgical debulking that included a hysterectomy and bilateral
salpingo-oophorectomy within the past 8 weeks

- Residual tumor after surgery (any single site) ≤ 2 cm in maximum dimension

- No carcinosarcoma

- No parenchymal liver metastases

- No recurrent endometrial cancer or endometrioid stage I or II with positive
peritoneal cytology


- GOG performance status 0-2

- Life expectancy ≥ 3 months

- WBC ≥ 3,000/mm^3

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- Creatinine ≤ ULN

- No myocardial infarction, unstable angina, or uncontrolled arrhythmia within the past
3 months

- No other active invasive malignancy within the past 5 years except for non-melanoma
skin cancer

- No history of serious co-morbid or uncontrolled illness that would preclude study


- See Disease Characteristics

- No prior pelvic or abdominal radiotherapy

- No prior chemotherapy for endometrial cancer

- No prior cancer treatment that would preclude study therapy

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence-free survival

Safety Issue:


Principal Investigator

Daniela E. Matei, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center



Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • endometrial clear cell carcinoma
  • endometrial papillary serous carcinoma
  • stage IA endometrial carcinoma
  • stage IB endometrial carcinoma
  • stage II endometrial carcinoma
  • stage IIIA endometrial carcinoma
  • stage IIIB endometrial carcinoma
  • stage IIIC endometrial carcinoma
  • stage IVA endometrial carcinoma
  • stage IVB endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
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Northwest Hospital and Medical Center Seattle, Washington  98133
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St. Agnes Hospital Cancer Center Baltimore, Maryland  21229
Renown Institute for Cancer at Renown Regional Medical Center Reno, Nevada  89502
Gynecologic Oncology of West Michigan Grand Rapids, Michigan  49546
Southwest Gynecologic Oncology Associates, Incorporated Albuquerque, New Mexico  87102
Women's Cancer Care Associates Albany, New York  12208
Schwartz Gynecologic Oncology Brightwaters, New York  11718
Black Hills Obstetrics & Gynecology LLP Rapid City, South Dakota  57701
Aurora Women's Pavilion of West Allis Memorial Hospital West Allis, Wisconsin  53227
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin  54904
Tufts Medical Center Cancer Center Boston, Massachusetts  02111
Central Dupage Cancer Center Warrenville, Illinois  60555
University of New Mexico Cancer Center - South Las Cruces, New Mexico  88011
New Ulm Medical Center New Ulm, Minnesota  56073
Southern Ohio Medical Center Cancer Center Portsmouth, Ohio  45662
Norton Suburban Hospital Louisville, Kentucky  40207
Providence Regional Cancer Partnership Everett, Washington  98201
St. Vincent Oncology Center Indianapolis, Indiana  46260
Zangmeister Center Columbus, Ohio  43219
Leonard Lawson Cancer Center at Pikeville Medical Center Pikeville, Kentucky  41501
Women's Institute for Gynecologic Cancer and Special Pelvic Surgery Phillipsburg, New Jersey  08865
PeaceHealth Medical Group, PC at St. Joseph Hospital Bellingham, Washington  98226
Olympic Medical Cancer Center Sequim, Washington  98382