ICON1 Study
International Collaborative Ovarian Neoplasm Trial 1: A Randomized Trial of Adjuvant Chemotherapy in Women With Early-Stage Ovarian Cancer (ICON1)
Disease site
Ovary
Pubmed link
Publication month/year
January 2003
Study question
Can adjuvant chemotherapy improve overall survival and prolong recurrence-free survival in women with early-stage epithelial ovarian cancer?
Type of study
Randomised controlled trial (RCT)
Interventions compared
Chemotherapy
Experimental arm (Intervention)
- Adjuvant chemotherapy immediately following surgery (n=241)
- Single agent Carboplatin or CAP (AUC every 3 weeks)
Control arm
- No adjuvant chemotherapy until clinically indicated (n = 236)
Primary outcome
- Overall survival (OS)
Secondary outcome
- Recurrence Free Survival (RFS)
Inclusion criteria
- Confirmed ovarian carcinoma of epithelial origin
- The clinician was uncertain as to whether to offer immediate adjuvant chemotherapy
- All visible tumour removed during surgery (Hysterectomy & Bilateral Salpingoopherectomy & Omenetectomy)
Exclusion criteria
- The patient was not fit to receive chemotherapy
- Patient had previous malignant disease (except nonmelanoma skin cancer)
- Patient had previous radiation therapy or chemotherapy
Results
Conclusions
- All patients with early-stage ovarian cancer should be considered for platinum-based adjuvant chemotherapy after removal of all visible tumour
- Single-agent Carboplatin should be considered as the treatment of choice
Study limitations
- Did not take in consideration pathological stage or tumour histology subtype/grade
- Recruitment significantly less than what was planned (Planned=2000, Actual= 477)
Additional resources
- The results were analysed with the ACTION trial
- Full text link: https://academic.oup.com/jnci/article/95/2/125/2912345