PILOT Phase of a trial looking at benefits of Hyperfractionated IMRT in locally advanced head and neck cancer.

Phase 1/2

Completed

• Conditions: Locally advanced stage III and IV squamous cell carcinoma of larynx and oropharynx

• Registration Number: CTRI/2010/091/000428
• Lead Sponsor: Chriatian Medical College , Vellore

Brief Summary

Head and neck cancer is one of the common cancers in the world, commonest in India, Bangladesh, Srilanka and Pakistan. In India, head and neck cancers (HNCA) account for 30-40% cancers at all sites1. It is the sixth common cause of death in males and seventh in females. About 90 percent of head and neck cancers are of the squamous cell variety. Although there have been significant improvements in chemotherapy and surgical techniques, the disease is often particularly challenging to treat since most patients present with advanced disease, have secondary tumours and suffer from other co-morbidities. Unfortunately 5-year survival rate has not improved (50% overall) for the last few decades except in specialized cancer centers. Treatment of the locally advanced head and neck malignancies need combined modality either with combination of surgery and radiotherapy or organ preservation technique with chemo-radiotherapy followed by salvage surgery. The major side effect from organ preservation therapy has been the xerostomia induced by high radiation doses to the parotid gland which is inevitable by conventional treatment delivery techniques. With intensity modulation and inverse planning parotid sparing has become the dictum in radiotherapy of head and neck malignancies. But the incidence of acute reaction remains the same as in conventional techniques 35% incidence of acute grade 3 and 4 reactions with radiotherapy in conventional fractionation with a 15 % increase with addition of concurrent chemotherapy3, which in turn leads to break in radiotherapy and decrease in loco regional control. We postulate that the radiobiological benefits with hyperfractionation if combined with that of the tissue sparing of IMRT delivery, would result in lesser incidence of acute and late toxicity than that is described for each independently. In this Phase 2 single arm study design we propose to treat 24 patients with HF IMRT to observe the incidence of acute grade 3 and 4 toxicities assuming equivalence of efficacy from published literature. In this PILOT phase we recruit 3 patients to see the appropriateness and feasibility of the protocol. Once PILOT phase is completed a larger phase II trial is planned to be undertaken.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-05
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

Age < 70 yrsSquamous cell carcinoma of oropharynx or hypopharynxT3, T4 and N0 or N+ and M0 / Stage III & Stage IV A and BECOG/ Performance score of 1 and 2Hb > 8.0 mg/dL.

Exclusion Criteria

History of prior irradiation to the loco-regional siteHistory of prior surgery or chemotherapyECOG/ Performance score of > 2Prior and concomitant associated diseases which are contraindications to radiotherapy like connective tissue disorders.Hb < 8.0 mg/dLAny psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether Hyper fractionated IMRT in locally advanced T3 T4, N0 N+ squamous cell carcinoma of the oropharynx and hypopharynx leads to a reduction in acute toxicity as compared to the historical data from the standard fractionated intensity modulated chemo-radiotherapy.	Week 1,2, 3 4 , 5, 6th, 6th week post radiotherapy, 6th month and end of first year

Secondary Outcome Measures

Name	Time	Method
econdary OutcomeTimepoints? To evaluate the incidence of late effects, grade 3 and 4 Xerostomia and dysphagia during the first year following the treatment evaluated using CTC AE v 3.0. ? To assess the Quality of life (QoL) using EORTC head and neck module for QoL ? To assess the loco regional control at the end of first year following completion of therapy.	Week 1,2, 3 4 , 5, 6th, 6th week post radiotherapy, 6th month and end of first year

Trial Locations

Locations (1)

Radiotherapy Unit 1; 🇮🇳 Vellore, TAMIL NADU, India

Radiotherapy Unit 1

🇮🇳Vellore, TAMIL NADU, India

Balu Krishna S

Principal investigator

04162283145

drbalunair@gmail.com