NCT00257335

Intensity-Modulated Radiotherapy for Recurrent Head and Neck Cancer

Withdrawn Phase 2 Last updated 31 July 2017

What this trial tests

Phase 2 trial testing IMRT in Carcinoma of the Head and Neck. Withdrawn.

Timeline

14 October 2004

Primary endpoint
12 June 2007

12 June 2007

Quick facts

Lead sponsor	Nilam Ramsinghani
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Start date	14 October 2004
Primary completion	12 June 2007
Estimated completion	12 June 2007

Drugs / interventions tested

• IMRT

Conditions studied

• Carcinoma of the Head and Neck — all drugs for Carcinoma of the Head and Neck →

Sponsor

Nilam Ramsinghani

Who can join

18 and older, any sex, with Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To demonstrate safety and efficacy of intensity-modulated radiotherapy (IMRT) for treatment of previously irradiated recurrent head and neck cancer.

Specific Aims: Identify acute and late toxicities, response rates, locoregional control, disease free survival, and overall survival with IMRT. Also, tumor response, the amount of tumor shrinkage or reduction, will be analyzed.

Rationale: Recurrent head and neck cancer is regarded as having limited treatment modalities since salvage surgery can only be accomplished on limited subgroups of patients. Chemotherapy has not shown clear clinical benefits and has significant toxicity. Re-irradiation has been used as a treatment modality. However, the re-irradiation dose is limited by significant toxicity that occurs with the cumulative dose of radiation. The use of IMRT can give a high dose to the recurrent tumor while limiting the dose to critical structures in the vicinity of the reirradiated volume thereby limiting toxicity and treating the recurrence to an adequate dose.

The number of subjects was determined from 2 stage design with a historical control group as comparison, and these numbers of subjects were found to be 40.

It is assumed that this treatment regimen will not be of further interest if the true response rate is less than 32.6% (Po0.326). It is also assumed that a true response rate of 53% or more (P10.53) would be of considerable interest in the treatment of recurrent head and neck cancer. The type I error (the probability of rejecting the hypothesis that the proportion responding to the treatment is less than or equal to Po when this hypothesis is actually true) is 0.05.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.