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CTRI Number  CTRI/2025/06/088227 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 23/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Testing High-Dose Radiotherapy to Cure Inoperable Oral Cavity Cancer : The DOSE-ROC Trial 
Scientific Title of Study   Randomized Controlled Trial on Efficacy of DOSe-Escalation Radiotherapy for Curative Treatment in Patients with Inoperable Oral Cavity Carcinoma-DOSE-ROC 
Trial Acronym  DOSE-ROC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ranalawala Murtuza Hakimuddin 
Designation  Junior resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  Regional cancer center, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanavantri nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9834050814  
Fax    
Email  murranala@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ambedkar Yadala 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  Regional cancer center, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanavantri nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8940866067  
Fax    
Email  ambioncologist@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ranalawala Murtuza Hakimuddin 
Designation  Junior resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  Regional cancer center, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanavantri nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9834050814  
Fax    
Email  murranala@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanavantri nagar, Pondicherry, India- 605006. 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dhanvantri Nagar, Puducherry 605006, India. 
Type of Sponsor  Research institution and hospital 
 
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 
Ranalawala Murtuza Hakimuddin  Jawaharlal Institute of Postgraduate Medical Education & Research  Department of Radiation Oncology, Regional Cancer Centre, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanavantri nagar, Pondicherry
Pondicherry
PONDICHERRY 		 9834050814

murranala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-Interventional Studies JIPMER, Pondicherry.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Escalated Dose Radiotherapy with/without Concurrent Chemotherapy  Patients in the intervention arm will receive radiation therapy to a total dose of 72.6 Gy in 33 fractions: 66 Gy in 30 fractions over 6 weeks to the high-risk volume, followed by a sequential boost of 6.6 Gy in 3 fractions over 3 days immediately after the completion of the 30 fractions. With/without Concurrent chemotherapy with intravenous Cisplatin (100 mg/m²) will be administered every 3 weeks during radiotherapy.  
Comparator Agent  Standard Dose Radiotherapy with/without Concurrent Chemotherapy  Patients in the comparator arm will receive standard radical radiotherapy of 66 Gray delivered in 30 fractions over 6 weeks to the high-risk volume using IMRT or VMAT technique with/without Concurrent chemotherapy with intravenous Cisplatin at 100 mg per square meter will be administered every 3 weeks during radiotherapy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ECOG Performance score 0, 1, 2
Patients having inoperable cancer of the oral cavity with TNM staging T1-4a N1-3b M0 and low volume T4b disease.
(inoperable would be defined as all the cases where surgery could not be done due to medical contraindications, logistic reasons, patient preference or any other reason defying surgery.)  
 
ExclusionCriteria 
Details  Tumors with fungating mass, oro-cutaneous fistula and extensive skin involvement.
Node with fungating mass and extensive skin involvement.
Patients received radiation earlier to head and neck region 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study is expected to increase the locoregional control in inoperable oral cavity cancers which in turn may improve the Progression free survival and Overall survival. The study can help us determine the toxicity profile with dose escalation as well.   To compare the locoregional control(LRC) at 3
months between dose escalation arm vs standard
arm. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of the quality of life between both
arms using EORTC QLQ HN35 questionnaire at
baseline & 3 months post treatment.
2. Proportion of patients developing acute side
effects of radiation using acute RTOG toxicity
scoring criteria & CTCAE version 5.0 toxicity
criteria.
3. To compare progression free survival(PFS) &
median overall survival(OS) in the intervention
group versus the control group.
 		 Quality of life will be assessed at baseline & 3 months post-treatment; acute toxicities (RTOG & CTCAE v5.0) will be recorded weekly during radiotherapy & at 1 & 6 weeks post-treatment; & progression-free survival (PFS) & overall survival (OS) will be monitored continuously during follow-up at 3-month intervals for 3 years. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   04/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  04/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a randomized controlled trial evaluating the efficacy of dose escalation in radiotherapy for patients with inoperable oral cavity carcinoma. Eligible patients will be randomized into two groups. The intervention arm will receive 66 Gy in 30 fractions followed by a boost of 6.6 Gy in 3 fractions using IMRT or VMAT technique along with concurrent chemotherapy. The control arm will receive standard radiotherapy of 66 Gy in 30 fractions with concurrent chemotherapy. The primary objective is to compare locoregional control at 3 months. Secondary objectives include assessment of quality of life, toxicity profiles, progression free survival, and overall survival. Patients will be followed up regularly for three years to monitor outcomes and toxicities.

 
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