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CTRI Number  CTRI/2010/091/000428 [Registered on: 02/06/2010]
Last Modified On: 25/02/2013
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Single Arm Study 
Public Title of Study   PILOT Phase of a trial looking at benefits of Hyperfractionated IMRT in locally advanced head and neck cancer. 
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Balu Krishna S 
Designation   
Affiliation   
Address  Assistant Professor
Radiotherapy Unit 1 Christian medical College Vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162283145  
Fax  04162232035  
Email  drbalunair@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Balu Krishna S 
Designation   
Affiliation  Tamil Nadu Medical council 
Address  Assistant Professor
Radiotherapy Unit 1 Christian medical College Vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162283145  
Fax  04162232035  
Email  drbalunair@gmail.com  
 
Details of Contact Person
Public Query  
Name  Balu Krishna S 
Designation   
Affiliation   
Address  Assistant Professor
Radiotherapy Unit 1 Christian medical College Vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162283145  
Fax  04162232035  
Email  drbalunair@gmail.com  
 
Source of Monetary or Material Support  
Instituitional Research Grant, Christian Medical College Vellore 
 
Primary Sponsor  
Name  Chriatian Medical College , Vellore 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Balu Krishna S  Radiotherapy Unit 1  Christian Medical College,Assistant Professor-632004
Vellore
TAMIL NADU 		 04162283145
04162232035
drbalunair@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chriatian Medical College, Instituitional Review Board, Research Office, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Locally advanced stage III and IV squamous cell carcinoma of larynx and oropharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Historical control  Standard fractionation of 66Gy in 33 fractions over 6-8 weeks 
Intervention  Hyperfractionated IMRT  Radiotherapy divided in to two fractions per day for 33 days achieve a total dose of 7920cGY 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  Age < 70 yrs Squamous cell carcinoma of oropharynx or hypopharynx T3, T4 and N0 or N+ and M0 / Stage III & Stage IV A and B ECOG/ Performance score of 1 and 2 Hb > 8.0 mg/dL  
 
ExclusionCriteria 
Details  History of prior irradiation to the loco-regional site History of prior surgery or chemotherapy ECOG/ Performance score of > 2 Prior and concomitant associated diseases which are contraindications to radiotherapy like connective tissue disorders. Hb < 8.0 mg/dL Any 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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
econdary Outcome Timepoints ? 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 
 
Target Sample Size   Total Sample Size="3"
Sample Size from India="" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  05/05/2010 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 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. 
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