ACTION Study

Disease site

Ovary

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
Observation Chemotherapy
Randomised(n) 224 224
median follow up (months) 66 66
Alive no recurrence(n,%) 150(69%) 175(79%)
alive and recurrence 23(11%) 13(6%)
Dead no recurrence(n,%) 8(4%) 5(2%)
Dead after recurrence(n,%) 37(17%) 26(12%)
Over all survival (%) 78% 85%
Recurrence free survival (%) 68% 76%
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
Reviewer name