ACTION Study
Disease site
Ovary
Pubmed link
Publication month/year
2003 January
Study question
To comare the outcome platinum-based adjuvant chemotherapy with no further treatment (i.e., observation) following surgery in patients with early-stage ovarian cancer who had adequate surgical stage.
Type of study
Randomised controlled trial (RCT)
Interventions compared
Chemotherapy vs Observation
Experimental arm (Intervention)
Chemotherapy
Control arm
Observation
Primary outcome
- Overall survival (OS)
Secondary outcome
- Recurrence Free Survival (RFS)
Inclusion criteria
- Stage & Grade:
- Ia–Ib (grade II–III)
- Ic and IIa (all tumour grades)
- All stages I–IIa with clear-cell epithelial cancer
- Received adequate surgical staging
Exclusion criteria
- Patients with a prior or concomitant second malignancy
- Patients with a World Health Organization (WHO) performance status of more than 3
- Previous treatment with chemotherapy or radiation therapy
- Interval of more than 6 weeks between surgical staging procedure and randomisation
- Non-compliance with follow up
Results
Conclusions
- OS: No difference between the two arm
- RFS: Improvement in chemotherapy arm
- Prognostic factors: – Cell type – Cancer grade – Completeness of staging
Study limitations
- Small sample size (predicted: 1000, recruited: 448)
- Surgical stratification analysis was a retrospective rather than prospective
Additional resources
- Full text: https://academic.oup.com/jnci/article/95/2/113/2912344
- The outcomes of ACTION Trial and ICON1 study were combined (separate publication)