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CTRI Number  CTRI/2018/08/015531 [Registered on: 30/08/2018] Trial Registered Prospectively
Last Modified On: 28/08/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating role of Adaptive radiotherapy in head neck cancers in reducing salivary gland toxicity 
Scientific Title of Study   Reducing Salivary Toxicity with Adaptive Radiotherapy : A Randomized Controlled trial. 
Trial Acronym  ReSTART 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarbani Ghosh Laskar 
Designation  Professor Radiation Oncologist 
Affiliation  Tata Memorial Hospital 
Address  1126,11th floor, Homi Bhabha Block Tata Memorial Hospital Parel,Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820834386  
Fax    
Email  sarbanilaskar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarbani Ghosh Laskar 
Designation  Professor Radiation Oncologist 
Affiliation  Tata Memorial Hospital 
Address  1126,11th floor, Homi Bhabha Block Tata Memorial Hospital Parel,Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820834386  
Fax    
Email  sarbanilaskar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sarbani Ghosh Laskar 
Designation  Professor Radiation Oncologist 
Affiliation  Tata Memorial Hospital 
Address  1126,11th floor, Homi Bhabha Block Tata Memorial Hospital Parel,Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820834386  
Fax    
Email  sarbanilaskar@gmail.com  
 
Source of Monetary or Material Support  
Intramural Funds - Tata Memorial Hospital. Address - Jerbai Wadia Road. Parel Mumbai 400012, Maharashtra  
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital E. Borges Rd, Parel Mumbai - 400012  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarbani Ghosh Laskar  Tata Memorial Hospital  OPD 206/205 HBB Tata Memorial Hospital Parel,Mumbai
Mumbai
MAHARASHTRA 		 9820834386

sarbanilaskar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Arm A - Standard IMRT arm   Arm A: Standard Arm: Patients will receive curative radiotherapy to head and neck using IMRT technique to a standard dose of 66 Gy in 30 fractions over 6 weeks. A standard three dimensional planning target volume (PTV) margin of 5 mm will be used. The setup verification will be done using electronic portal imaging device (EPID) in the first three fractions and weekly thereafter as per standard practice. No routine soft tissue imaging will be done.  
Intervention  Experimental Arm B - A-IGRT  Head and neck cancer patients planned for curative radiotherapy with concurrent chemotherapy at Department of Radiation Oncology, Tata Memorial centre, who fit the eligibility criteria will be screened for the trial. Patients who consent to participate in the trial will be registered into the trial prior to the start of chemo-radiation. Patients will be randomized after contouring the clinical target volume (CTV), just prior to radiation planning. Patients will be allocated to 2 groups in the ratio of 1:1 by electronic randomisation. Experimental Arm (Arm B): Patients will receive adaptive image guided radiotherapy (A-IGRT) with margin reduction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Biopsy proven Squamous cell carcinoma of the oropharynx, hypopharynx and larynx.
2.AJCC stage T1-3, N0-2c, M 0.
3.KPS ≥ 70.
4.Age ≥18 and ≤ 70 years.
5.Patient willing and reliable for follow-up.
6.Patient’s nutritional & physical condition compatible with planned therapy.
7.Signed study specific consent form. 
 
ExclusionCriteria 
Details  1.T1-2 N0 M0 of Vocal cords
2.History of surgery for the primary or node in head and neck.
3.Evidence of distant metastases or N3 nodal stage.
4.Previous therapeutic irradiation for head & neck cancer.
5.Patients who have received neoadjuvant chemotherapy.
6.Active untreated infection, which preclude the use of systemic chemotherapy or would interfere with completion of treatment.
7.Any histopathology other than Squamous Carcinoma.
8.Primary nasopharyngeal or paranasal sinus cancers.
9.Pregnancy or lactating women.
10.Previous history of malignancy within 5 years.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Salivary toxicity at 12 months post radiation: The acute salivary toxicity will be assessed with salivary scintigraphy. The salivary function at 12 months will be determined by the ratio of SEF at 12 months after treatment compared to the baseline SEF (pre-treatment) x 100%.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the acute and late normal tissue toxicity.
2.To compare the loco-regional control.
3.To compare the disease free survival.
4.To compare the overall survival.
5.To compare the quality of life in patients randomized to the two study arms.
6.To assess parotid shrinkage over time and document the dosimetric changes. 		 1, 3 , 5 yrs 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   03/09/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

IMRT is widely accepted as the standard treatment for head and neck cancers. As dose application becomes more precise, various factors may lead to a deviation in the intended radiation dose delivery like daily setup variations and geometric and volumetric changes during the course of RT. This inaccuracy may lead to either under dosage of the target volume with resultant risk of tumour recurrence or over dosage of the normal tissues leading potential risk of increased complications. This has led to the development of an adaptive radiation scheme with periodic adjustment of the treatment plan that takes into account such treatment-related anatomic changes and protects parotid glands from an overdose of irradiation.Hence this study is planned to assess the efficacy of adaptive radiotherapy in reducing salivary toxicity in head and neck cancer patients.

 
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