NCT00002477 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: UNKNOWN
Registry last update: 2013-12-18

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility 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
healthy Volunteers: false
sex: FEMALE
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

interventions

name
carboplatin
type
DRUG
name
cisplatin
type
DRUG
name
cyclophosphamide
type
DRUG
name
doxorubicin hydrochloride
type
DRUG

Study design

primary Purpose: TREATMENT

Enrollment

Source null

Registered outcome plans (not posted results)

Full study description

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.

Source references

references

citation
Colombo N, Trimbos JB, Guthrie D, et al.: ACTION + ICON1: two parallel randomised phase III trials comparing adjuvant chemotherapy to no adjuvant chemotherapy following surgery in women with high risk early ovarian cancer. [Abstract] Eur J Cancer 37 (suppl 6): A-1019, s276, 2001.
type
BACKGROUND
citation
Swart AC: Long-term follow-up of women enrolled in a randomized trial of adjuvant chemotherapy for early stage ovarian cancer (ICON1). [Abstract] J Clin Oncol 25 (Suppl 18): A-5509, 276s, 2007.
type
RESULT
citation
Guthrie D: ICON1: a randomised trial of immediate platinum-based chemotherapy against chemotherapy delayed until indicated in women with ovarian cancer. [Abstract] Br J Cancer 85 (suppl 1): A-9.1, 28, 2001.
type
RESULT
citation
Vergote IB, Trimbos BJ, Guthrie D, et al.: Results of a randomized trial in 923 patients with high-risk early ovarian cancer, comparing adjuvant chemotherapy with no further treatment following surgery. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-802, 2001.
type
RESULT

Source notices and limitations

Discovery and provenance

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source title
Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: May 14, 2025
datetime
2025-05-14T12:00:00Z
display
May 14, 2025
source url
https://www.cancer.gov/types/ovarian/hp/ovarian-epithelial-treatment-pdq

Preserved source evidence · Not medical advice