Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	any age	Other	MRC-ICON1 EU-91002, NCT00002477

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.

Entry Criteria

Disease Characteristics:

Histologically confirmed invasive ovarian cancer of epithelial origin

All tumor resected prior to randomization

Uncertain whether immediate chemotherapy is required

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

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

Expected Enrollment

A maximum of 2,000 patients will be randomized.

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.

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.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Christopher Williams, DM, FRCP, Protocol chair(Contact information may not be current)		Ph: 44-1865-226-628 Email: christopher.williams@ubht.swest.nhs.uk

Registry Information
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
Trial Start Date		1991-04-01
Registered in ClinicalTrials.gov		NCT00002477
Date Submitted to PDQ		1991-04-01
Information Last Verified		2007-07-09