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A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma

Phase 3
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma


- Compare survival and progression-free survival in patients with stage III endometrial
carcinoma treated with tumor volume-directed pelvic radiotherapy with or without
paraaortic radiotherapy followed by cisplatin and doxorubicin with or without

- Compare short and long-term toxic effects of these treatment regimens in this patient

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
radiotherapy field (pelvic vs extended field).

Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy
with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16
weeks after surgery.

Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy
treatment arms.

- Arm I: Patients receive doxorubicin IV over 30 minutes immediately followed by
cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF)
subcutaneously (SC) or pegfilgrastim on days 2-11.

- Arm II: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3
hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12.

Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this
study within 5.2 years.

Inclusion Criteria


- Histologically confirmed advanced endometrial carcinoma with any histology,

- Clear cell and serous papillary carcinoma

- Surgical stage III disease, including:

- Positive adnexa

- Tumor invading the serosa

- Positive pelvic and/or paraaortic nodes

- Involvement of bowel mucosa

- Intraabdominal metastases

- Positive pelvic washings

- Vaginal involvement within the radiation port

- Must have had prior surgery, including hysterectomy and bilateral

- Tumor maximally debulked to a maximum residual diameter of no greater than 2 cm

- Paraaortic lymph node sampling allowed

- If positive, must have negative chest CT scan

- No recurrent disease

- No parenchymal liver metastases

- No disease outside the abdomen



- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- At least 3 months


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times normal

- SGOT/SGPT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal


- Creatinine no greater than 1.6 mg/dL


- LVEF at least 50% within 6 months of study entry


- No other prior or concurrent malignancy within the past 5 years except adequately
treated nonmelanoma skin cancer

- No serious comorbid illness that would preclude study participation


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- No prior pelvic or abdominal radiotherapy

- No prior radiotherapy for prior malignancy


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Howard D. Homesley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology Network


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage III endometrial carcinoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial adenoacanthoma
  • endometrial papillary serous carcinoma
  • endometrial clear cell carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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