Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer (NCT01566240)
A Phase III Multicentre Trial of Weekly Induction Chemotherapy Followed by Standard Chemoradiation Versus Standard Chemoradiation Alone in Patients With Locally Advanced Cervical Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Instituto do Câncer do Estado de São Paulo — São Paulo
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (35 Sites)
Showing the first 25 of 35 sites.
- Instituto do Câncer do Estado de São Paulo — São Paulo,
- Chittaranjan National Cancer Institute (CNCI) — Kolkata,
- Saroj Gupta Cancer Centre and Research Institute — Kolkata,
- Istituto Europeo di Oncologia — Milan, Lombardy
- Instituto Nacional de Cancerologia (INCAN) — Mexico City,
- North Devon District Hospital — Barnstaple, Devon
- University College London Hospital — London, Greater London
- Weston Park Hospital — Sheffield, South Yorkshire
- Belfast City Hospital — Belfast,
- Pilgrim Hospital — Boston,
- Royal Sussex County Hospital — Brighton,
- Velindre Cancer Centre — Cardiff,
- Cheltenham General Hospital — Cheltenham,
- Royal Derby Hospital — Derby,
- Royal Devon and Exeter NHS Foundation Trust — Exeter,
- Beatson WOSCC — Glasgow,
- Gloucester Royal Hospital — Gloucester,
- Grantham and District Hospital — Grantham,
- Castle Hill Hospital — Hull,
- Leicester Royal Infirmary — Leicester,
- Lincoln County Hospital — Lincoln,
- Guy's and St Thomas' NHS Foundation Trust — London,
- Imperial College Healthcare NHS Trust — London,
- St Bart's Hospital — London,
- The Christie NHS Foundation Trust — Manchester,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.