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Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer — DEPICT  

Locally Advanced Cervical Cancer Clinical Trial

Official title:
A Phase I/II, Multi-centre Dose Escalation Study of Simultaneous Boost Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer

Clinical Trial Summary

This will be the first study to assess the clinical feasibility of dose escalation with simultaneous integrated boost intensity-modulated radiotherapy for patients with locally advanced cervical cancer. Following screening to confirm eligibility patients will commence a six week treatment period. After this, patients will be followed up by visits to clinic every 3 months for a period of 24 months (2 years). End of study is defined as 24 months after treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after treatment.

Clinical Trial Description

1. Primary objective

- To determine the feasibility of dose escalation with simultaneous boost intensity-modulated radiotherapy (IMRT) in locally advanced cervical cancer

2. Secondary Objectives

- To assess objective response rates

- To assess local control

- To correlate toxicity with dose-volume histogram data

3. Primary endpoint

- Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v3.0 (Common Terminology for Adverse Events)

4. Secondary endpoints

- Response rate assessed radiologically at 3 months and 12 months

- Local control at 2 years

- Late toxicity at 2 years as defined by CTCAE v3.0 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01793701
Study type Interventional
Source Queen Mary University of London
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date July 2010
Completion date April 2018
View Details
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