Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Not specified NCI GOG-0184 ECOG-G0184, RTOG-EN0130, NCT00006011, GOG-0184

Objectives

1. 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 paclitaxel.
2. Compare short and long-term toxic effects of these treatment regimens in this patient population.

Entry Criteria

Disease Characteristics:

• Histologically confirmed advanced endometrial carcinoma with any histology, including:
  • 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 salpingo-oophorectomy
  • 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior pelvic or abdominal radiotherapy
• No prior radiotherapy for prior malignancy

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times normal
• SGOT/SGPT no greater than 3 times normal
• Alkaline phosphatase no greater than 3 times normal

Renal:

• Creatinine no greater than 1.6 mg/dL

Cardiovascular:

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

Other:

• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Howard Homesley, MD, Protocol chair		Ph: 252-756-5388 Email: hdh7173@aol.com

Eastern Cooperative Oncology Group

Higinia Cardenes, MD, PhD, Protocol chair		Ph: 317-274-2524; 888-600-4822 Email: hcardene@iupui.edu

Registry Information
Official Title		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
Trial Start Date		2000-07-03
Registered in ClinicalTrials.gov		NCT00006011
Date Submitted to PDQ		2000-05-26
Information Last Verified		2004-09-21
NCI Grant/Contract Number		CA27469