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CTRI Number  CTRI/2025/10/096035 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment Comparison of Two Chemotherapy Drugs (Carboplatin or Cisplatin) Given with Radiation in Head and Neck Cancer 
Scientific Title of Study   Carboplatin or Cisplatin as Radiosensitizer in Head and Neck Cancer Patients for Curative or Adjuvant Chemoradiation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4767  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nandini Menon 
Designation  Professor and Medical Oncologist 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Centre OPD No 204 2nd Floor , Homi Bhabha block , Medical onology Department Dr E Borges Marg Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  09769178270  
Fax    
Email  nandini.menon1412@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nandini Menon 
Designation  Professor and Medical Oncologist 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Centre OPD No 204 2nd Floor , Homi Bhabha block , Medical onology Department Dr E Borges Marg Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  09769178270  
Fax    
Email  nandini.menon1412@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nandini Menon 
Designation  Professor and Medical Oncologist 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Centre OPD No 204 2nd Floor , Homi Bhabha block , Medical onology Department Dr E Borges Marg Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  09769178270  
Fax    
Email  nandini.menon1412@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Department of Medical Oncology Dr E Borges Road Parel Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Kumar  Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur  Department of Medical Oncology, Room no 108, HBCH & RC, SKMCH Campus, Uma Nagar, Rasulpur, Muzaffarpur 842004
Muzaffarpur
BIHAR 		 9264493969

gaurav_crj@rediffmail.com 
Dr Nandini Menon  Tata Memorial Hospital  OPD No 204 2nd Floor , Homi Bhabha block , Medical onology Department Dr E Borges Marg Parel
Mumbai
MAHARASHTRA 		 09769178270

nandini.menon1412@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (2) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (3) ICD-10 Condition: C09||Malignant neoplasm of tonsil, (4) ICD-10 Condition: C10||Malignant neoplasm of oropharynx, (5) ICD-10 Condition: C00||Malignant neoplasm of lip, (6) ICD-10 Condition: C03||Malignant neoplasm of gum, (7) ICD-10 Condition: C04||Malignant neoplasm of floor of mouth, (8) ICD-10 Condition: C05||Malignant neoplasm of palate, (9) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Carboplatin with concurrent radiotherapy (RT)  Dosage regimen- Inj. Carboplatin AUC 2 IV weekly (maximum of 7 cycles) Route of administration- Intravenous infusion Frequency and duration- Weekly for a maximum of 7 cycles, given concurrently with radiotherapy (same RT protocol as Arm A) Concomitant therapy- Radiotherapy (conventional or IMRT as per institutional protocol) 
Comparator Agent  Cisplatin with concurrent radiotherapy (RT)  Dosage regimen Inj. Cisplatin 100 mg per m² IV every 3 weeks Route of administration-Intravenous infusion Frequency and duration- Every 3 weeks for a maximum of 3 cycles, given concurrently with radiotherapy (60–70 Gy in 30–35 fractions over 6–7 weeks) Concomitant therapy: Radiotherapy (conventional or IMRT as per institutional protocol) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Participants must have histologically confirmed Stage III to IV squamous cell carcinoma of the head and neck region as per AJCC UICC 8th edition

2.Participants must warrant concurrent chemoradiation CTRT in one of the following settings
a Definitive radical setting Stage III to IV head and neck cancer
b Adjuvant setting Stage III to IV head and neck cancer post surgery with one or more of the following pathological features
i Extracapsular extension
ii Positive surgical margin
iii Close surgical margin 5 mm or below

3.Primary tumor site must be one of the following oral cavity pharynx including oropharynx and hypopharynx larynx including supraglottis glottis or subglottis or carcinoma of unknown primary CUP with neck node involvement

4.Age 18 years and above no upper age limit

5.ECOG performance status 2 or less

6.Participants must have adequate organ and marrow function as defined below
a Hemoglobin 9 g per dL or more
b Leukocytes 3000 per cumm or more
c Absolute neutrophil count 1500 per cumm or more
d Platelet count 100000 per cumm or more
e Total bilirubin less than 1 point 5 times the upper limit of normal
f AST SGOT and ALT SGPT 1 point 5 times the upper limit of normal or less
g Creatinine clearance 50 mL per minute or more

7.Both male and female participants of all races and ethnic groups are eligible

8.Willing and able to comply with all study requirements

9.Ability to understand and willingness to sign a written informed consent document 
 
ExclusionCriteria 
Details  1.Participants who are receiving any other investigational agents for the treatment of cancer.
2.Primary in the major salivary glands, nasopharynx, melanoma, and cutaneous malignancies in the head and neck region.
3.Participants with QTc prolongation, defined as a QTc interval greater than 500 milliseconds.
4.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in the study.
5.Participants with Grade 2 or higher sensorineural hearing loss, as per the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 5.0. Participants with only conductive hearing loss and no sensorineural component will not be excluded.
6.Uncontrolled intercurrent illness including, but not limited to tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia (CTCAE version 5.0 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.
7.Pregnant women and women who are breastfeeding will be excluded from this study. Both Cisplatin and Carboplatin cross the placenta and can cause fetal harm if administered during pregnancy. Women of child-bearing potential (WOCBP) and male participants with partners of child-bearing potential must agree to use effective contraception. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Cisplatin and Carboplatin have been detected in breast milk. Breastfeeding should be avoided or discontinued in patients receiving Cisplatin and Carboplatin due to the potential for toxicity in the breastfed infant.
8.Participants with HIV infection with a CD4 count less than 200, active Hepatitis B, and active Hepatitis C infection are excluded from this study. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare 2-year overall survival (OS) between Carboplatin-based and Cisplatin-based chemoradiation   baseline, 4 weeks, 8 weeks, end of treatment, and during follow-up up to 24 months. 
 
Secondary Outcome  
Outcome  TimePoints 
a.To compare 2-year PFS between carboplatin based CTRT (Carb-CTRT) and cisplatin based CTRT(C-CTRT)
b.To compare acute and late toxicity between carboplatin based CTRT (Carb-CTRT) and cisplatin based CTRT(C-CTRT) 		 a. 3 months, 6 months,9 months , 12 months,18 months and 24 months.
b.cute toxicities will be assessed weekly during treatment and late toxicities at 3 months, 6 months,9 months , 12 months,18 months and 24 months. 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   24/10/2025 
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="6"
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 cancer is one of the most common cancers in India. Cisplatin given with radiotherapy is the current standard of care for patients with locally advanced disease. However, many patients cannot tolerate Cisplatin due to its side effects or poor kidney function. Carboplatin is often considered a safer alternative, but there is limited evidence comparing its effectiveness with Cisplatin when used with radiation in curative or adjuvant settings.

This study aims to compare the outcomes of patients receiving Carboplatin or Cisplatin as radiosensitizers along with radiotherapy in Stage III and IV squamous cell carcinoma of the head and neck region. The study will include patients receiving treatment in either definitive or postoperative adjuvant settings. Participants will be randomized into two arms. One group will receive concurrent Cisplatin and radiotherapy, and the other group will receive concurrent Carboplatin and radiotherapy.

The primary objective is to compare the treatment response between the two regimens based on RECIST criteria after completion of chemoradiation. Secondary objectives include comparison of toxicity profile, progression free survival, overall survival, compliance, and quality of life.

Eligible participants will be adults aged 18 years or above with histologically confirmed Stage III or IV squamous cell carcinoma of the oral cavity, pharynx, larynx, or carcinoma of unknown primary with neck node involvement. Patients will receive either weekly Carboplatin AUC 2 with radiotherapy or Cisplatin 100 mg per m2 every three weeks with radiotherapy as per institutional protocol.

Patients will be evaluated clinically and radiologically for response and toxicity during and after treatment. Follow up will continue for at least two years to assess disease control, survival, and late toxicities. The study will help determine whether Carboplatin can be used as an effective and safer alternative to Cisplatin in head and neck cancer patients undergoing chemoradiation.

 
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