Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Completed	no age specified	NCI	GOG-14

Objectives

I.  Compare the effectiveness of 3-drug chemotherapy with actinomycin-D 
(ACT-D), 5-fluorouracil (5-FU) and cyclophosphamide (CTX) with radiotherapy 
for malignant tumors of the ovarian stroma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with malignant tumors of the 
ovarian stroma including granulosa-cell cancers, granulosa thecal-cell cancers 
and arrhenoblastomas that have spread either locally or to distant sites.  
Laparotomy must be performed and a maximum possible amount of tumor excised 
prior to entry.  Therapy must begin a minimum of 2 weeks and a maximum of 4 
weeks after surgery.

Expected Enrollment

Protocol closed April 1981 and terminated October 1981.

Outline

Randomized study.
(Changed to nonrandomized Study, July 1975 - Amendment #1).
Arm I:  3-Drug Combination Chemotherapy.  Actinomycin-D, ACT-D, NSC-3053; 
5-Fluorouracil, 5-FU, NSC-19893; Cyclophosphamide, CTX, NSC-20271.
Arm II:  Radiotherapy - to entire abdomen by open fields followed by 
irradiation to the pelvis or to the area of residual tumor through parallel 
opposed anterior and posterior portals.
Randomization is discontinued and treatment for patients entering this study 
is optional.  Radiation therapy is suggested as a primary treatment modality 
followed by chemotherapy when appropriate.  C Amendment #1, July 1975).

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

George Lewis, MD, Protocol chair		Ph: 215-955-8461; 800-533-3669 Email: 73522.1357@compuserve.com