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CTRI Number  CTRI/2024/10/075865 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Single Arm Study 
Public Title of Study   Targeted Radiation Dose Escalation for Head and Neck Cancer with PET-CECT 
Scientific Title of Study   Evaluating the Role of PET-CECT Based Radiation Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients - A phase II, Prospective, Single Institution Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anoushka Taneja 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Radiotherapy and Oncology , KMC Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7397303725  
Fax    
Email  anoushka1.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Umesh Velu 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Radiotherapy and Oncology , KMC Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8700105161  
Fax    
Email  umesh.vellu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Anoushka Taneja 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Radiotherapy and Oncology , KMC Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka


KARNATAKA
576104
India 
Phone  7397303725  
Fax    
Email  anoushka1.kmcmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka - 576104, India 
 
Primary Sponsor  
Name  N/A 
Address  N/A 
Type of Sponsor  Other [N/A] 
 
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 Anoushka Taneja  Kasturba Medical College, Manipal  Department of Radiotherapy and Oncology,Room No. 01, Department of Nuclear Medicine, Room No. 03, Shirdi Sai Baba Cancer Block, Manipal Comprehensive Cancer Care Centre, Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka - 576104
Udupi
KARNATAKA 		 7397303725

anoushka1.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00||Malignant neoplasm of lip, (2) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (3) ICD-10 Condition: C02||Malignant neoplasm of other and unspecified parts of tongue, (4) ICD-10 Condition: C03||Malignant neoplasm of gum, (5) ICD-10 Condition: C04||Malignant neoplasm of floor of mouth, (6) ICD-10 Condition: C05||Malignant neoplasm of palate, (7) ICD-10 Condition: C06||Malignant neoplasm of other and unspecified parts of mouth, (8) ICD-10 Condition: C07||Malignant neoplasm of parotid gland, (9) ICD-10 Condition: C08||Malignant neoplasm of other and unspecified major salivary glands, (10) ICD-10 Condition: C09||Malignant neoplasm of tonsil, (11) ICD-10 Condition: C10||Malignant neoplasm of oropharynx, (12) ICD-10 Condition: C11||Malignant neoplasm of nasopharynx, (13) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (14) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx, (15) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  positron emission tomography-computed tomography (PET-CECT) based radiation dose escalation in patients with head and neck cancer undergoing radical treatment  Patients will undergo PET-CECT imaging for radiation therapy planning as opposed to CT-based planning which is the standard of care. Hypermetabolic regions with a standardised uptake value (SUV) max greater than 3 representing the biological target volume (BTV) will receive an escalated radiation dose of 2.2 Gy per fraction while maintaining standard doses to other areas. Individualised treatment plans for each patient will be designed and patients will receive intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT) with a dose of 77 Gy in 35 fractions over 7 weeks (2.2 Gy per fraction, 1 fractions daily for 5 days a week Monday to Friday), with/without concurrent chemotherapy with either Cisplatin or Carboplatin, on a weekly basis, depending on creatinine clearance.  
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1)Histologically confirmed diagnosis of HNSCC 2)Tumour sites - head and neck 3)Age - adults between 18-75 years 4)Performance status - ECOG 1-2 5)No prior head and neck radiation therapy - patients undergoing radical/ definitive RT/RT-CT 6)Patients who have understood and agreed to participate in the study by signing written informed consent including regular follow-up
 
 
ExclusionCriteria 
Details  1)Tissue biopsy diagnosis other than HNSCC
2)Postoperative patients
3)Prior head and neck irradiation
4)Metastatic disease/ palliative status
5)Severe comorbidities
6)Pregnancy
7)Contraindications to PET-CECT
8)Patients unwilling to participate in study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Local Control  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Progression-free Survival  1 year 
Overall Survival  1 year 
Treatment-related toxicity  1 year 
Quality of life  1 year 
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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   N/A 
Date of First Enrollment (India)   04/11/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Head and neck squamous cell carcinoma (HNSCC) represents a significant clinical challenge due to its aggressive nature and potential for local and distant spread. Standard radiation therapy planning often lacks precision in targeting hypermetabolic regions, which may contribute to suboptimal treatment outcomes. The integration of positron emission tomography-computed tomography (PET-CECT) in radiation planning allows for the identification of hypermetabolic regions, potentially enabling dose escalation specifically to these areas. This approach may improve local control and overall survival while maintaining manageable levels of treatment-related toxicity. 
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