Background
Phase III RCT (Genova Trial). 70 patients with stage I-III epithelial ovarian cancer (completely resected, residual disease <2 cm). Compared adjuvant chemotherapy (cisplatin-based) vs whole abdominal radiotherapy (WART) after primary debulking surgery. This Italian trial was one of the first to directly compare systemic chemotherapy to adjuvant WART in ovarian cancer, addressing which modality should be standard.
Interventions and follow up
Arm A: Adjuvant chemotherapy — cisplatin-based regimen (6 cycles)
Arm B: Whole abdominal radiotherapy (WART) — 30 Gy whole abdomen + pelvic boost
Primary endpoint: Disease-free survival, OS
mFollow up: ~5 year
Arm B: Whole abdominal radiotherapy (WART) — 30 Gy whole abdomen + pelvic boost
Primary endpoint: Disease-free survival, OS
mFollow up: ~5 year
Results
5-year DFS: Chemotherapy arm superior (approximately 58% vs 38%)
5-year OS: Chemotherapy arm superior
Subgroup: No significant WART benefit in any stage subgroup
5-year OS: Chemotherapy arm superior
Subgroup: No significant WART benefit in any stage subgroup
Adverse events
Main adverse events: WART: significant acute GI toxicity, late bowel complications. Chemotherapy: hematologic toxicity, nephrotoxicity (cisplatin-based), neuropathy. Both approaches associated with meaningful toxicity.
Conclusions
Cisplatin-based adjuvant chemotherapy was superior to WART in disease-free and overall survival for early-to-intermediate stage ovarian cancer, supporting chemotherapy over radiotherapy as the preferred adjuvant modality.
Key Limitations
Key Limitations: Small sample size (70 patients) — underpowered for definitive conclusions. Older platinum regimens (cisplatin monotherapy or combinations) not equivalent to modern carboplatin + paclitaxel. Stage mix (I–III) creates heterogeneity. WART technique was open-field; modern IMRT could potentially improve toxicity profile. This was a single Italian institution trial.
Clinical Context
The Genova trial, along with other comparative studies, helped shift adjuvant ovarian cancer treatment from WART to chemotherapy. Combined with GOG 7602 and pharmacological advances (cisplatin → carboplatin + paclitaxel), the evidence firmly established platinum-based chemotherapy as the adjuvant standard. WART is no longer used as frontline adjuvant therapy for ovarian cancer in routine practice.
References