PILOT phase of a single arm phase II trial to assess the toxicity and efficacy of hyper-fractionated IMRT (Intensity Modulated Radiotherapy) in radical treatment of locally advanced head and neck squamous cell carcinoma.

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.