drugset / Trial / NCT01566240

Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer

NCT01566240 ↗

Phase 3 Active not recruiting 500 enrolled University College, London Cancer Research UK · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Chemoradiation has been the standard treatment for advanced cervical cancer for a decade, but one third of women still die from a failure to control systemic disease. In a recent multicentre phase II trial of 46 women the investigators found that, 68% of women had tumours that responded to weekly induction chemotherapy prior to chemoradiation. The induction chemotherapy had acceptable toxicity and did not compromise the standard chemoradiation treatment. In addition, the overall survival and progression free survival at 3 years was 66% (95% CI 4779). These results, together with acceptable toxicity, provide justification for evaluating induction chemotherapy prior to chemoradiation in a randomised phase III trial. The investigators aim to investigate in a randomised trial whether additional induction chemotherapy given on a weekly schedule immediately before standard chemoradiation leads to an improvement in overall survival. The investigators plan to recruit 770 women with locally advanced cervical cancer who are eligible for standard chemoradiation, they will be randomised to weekly carboplatin and paclitaxel chemotherapy for 6 weeks followed by chemoradiation or to chemoradiation alone. The trial will recruit for 4 years with 5 years of follow up period.

Timeline

Start
2012-11-08
Primary completion
2026-02
Completion
2026-12

Outcome

Met primary endpoint

paper 5-year progression-free survival rates were 72% in the induction chemotherapy with chemoradiotherapy group and 64% in the chemoradiotherapy alone group PMID 39419054 ↗

paper with a hazard ratio (HR) of 0·65 (95% CI 0·46-0·91, p=0·013). PMID 39419054 ↗

paper 5-year overall survival rates were 80% in the induction chemotherapy with chemoradiotherapy group and 72% in the chemoradiotherapy alone group PMID 39419054 ↗

paper with an HR of 0·60 (95% CI 0·40-0·91, p=0·015). PMID 39419054 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 2 unknown Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Cisplatin Other / unclassified 40 mg/m2 Intravenous

Indications