Adjuvant Chemotherapy Compared With Observation in Treating Patients With Resected Early Stage Ovarian Epithelial Cancer

Phase III Randomized Study of Adjuvant Therapy With a Platinum-Containing Regimen (e.g., CBDCA or CAP: CTX/DOX/CDDP) vs No Adjuvant Therapy in Patients With Fully Resected Early Stage Ovarian Cancer

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002477

Enrollment

Unknown

Registered

2004-05-26

Start date

1991-04-30

Completion date

Unknown

Last updated

2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

stage I ovarian epithelial cancer, stage II ovarian epithelial cancer

Brief summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant therapy using platinum-based chemotherapy drugs with no adjuvant therapy in treating patients with early stage invasive ovarian epithelial cancer.

Detailed description

OBJECTIVES: I. Determine whether adjuvant chemotherapy with a platinum-containing regimen (e.g., carboplatin or CAP: cyclophosphamide/doxorubicin/cisplatin) prolongs survival in patients with early stage ovarian cancer compared to those receiving no adjuvant treatment. OUTLINE: Randomized study. Patients are randomized to Arm I or II; treatment should begin within 6 weeks of surgery. Regimens listed in Arm I are recommended, but other platinum-containing regimens are allowed provided the doses at a minimum meet those listed below. Arm I: Single-agent Chemotherapy or 3-Drug Combination Chemotherapy. Carboplatin, CBDCA, NSC-241240; or CAP: Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; Cisplatin, CDDP, NSC-119875. Arm II: Observation. No adjuvant therapy. PROJECTED ACCRUAL: A maximum of 2,000 patients will be randomized.

Interventions

DRUGcarboplatin

DRUGcisplatin

DRUGcyclophosphamide

DRUGdoxorubicin hydrochloride

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed invasive ovarian cancer of epithelial origin All tumor resected prior to randomization Uncertain whether immediate chemotherapy is required PATIENT CHARACTERISTICS: Age: Any age Performance status: Sufficient to receive chemotherapy Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior malignancy except nonmelanomatous skin cancer No clear contraindication to chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Minimum recommended surgical procedures (when possible): Thorough surgical staging Total hysterectomy/bilateral salpingo-oophorectomy Omentectomy, as follows: Total supracolonic omentectomy if omentum involved Removal of distal 2 cm or infracolonic omentectomy in the absence of macroscopic disease

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026