Adjuvant Chemotherapy Compared With Observation in Treating Patients With Resected Early Stage Ovarian Epithelial Cancer - Full Text View

Sponsor:	Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002477

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer	Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Cyclophosphamide Cisplatin Doxorubicin Doxorubicin hydrochloride Carboplatin Myocet

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 1991

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002477

Locations

United Kingdom, England
Cochrane Cancer Network
Oxford, England, United Kingdom, OX3 7LF

Sponsors and Collaborators

Medical Research Council

Investigators

Study Chair:

Christopher J. Williams, DM, FRCP

Cochrane Cancer Network

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

Study ID Numbers:	CDR0000077026, MRC-ICON1, EU-91002
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00002477 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I ovarian epithelial cancer
stage II ovarian epithelial cancer

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Cyclophosphamide
Ovarian Diseases
Antibiotics, Antineoplastic
Genital Diseases, Female
Neoplasms by Site
Cisplatin
Therapeutic Uses
Alkylating Agents

Endocrine Gland Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Carboplatin
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Radiation-Sensitizing Agents
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 09, 2009