| CTRI Number |
CTRI/2025/12/099280 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective, Observational, Analytical, Open Level Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see how taking breaks during treatment with combined chemotherapy and radiotherapy affects recovery and disease progression in people with head and neck cancer patients. |
|
Scientific Title of Study
|
A Prospective Observational study to assess the Impact of Treatment Interruption on disease
outcome in Head and Neck Squamous Cell Carcinoma treated with Concomitant Chemo-
Radiotherapy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1332-8998 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreshth Vinaik |
| Designation |
Junior Registrar Year 1 |
| Affiliation |
Institute of Post Graduate Medical Education and Research Kolkata |
| Address |
Department of Radiotherapy
Chest and Cancer Block
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
7417258805 |
| Fax |
|
| Email |
shreshthvinaik2803@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Niladri B Patra |
| Designation |
Professor and Head of the Department |
| Affiliation |
Institute of Post Graduate Medical Education and Research Kolkata |
| Address |
Department of Radiotherapy
Chest and Cancer Block
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9874038399 |
| Fax |
|
| Email |
nbpatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niladri B Patra |
| Designation |
Professor and Head of the Department |
| Affiliation |
Institute of Post Graduate Medical Education and Research Kolkata |
| Address |
Department of Radiotherapy
Chest and Cancer Block
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9874038399 |
| Fax |
|
| Email |
nbpatra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shreshth Vinaik |
| Address |
Department of Radiotherapy IPGMER and SSKM Hospital
244 AJC Bose Road Kolkata |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Post Graduate Medical Education and Research Kolkata |
Department of Radiotherapy
Chest and Cancer Block
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata 700020 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreshth Vinaik |
Institute of Post Graduate Medical Education and Research Kolkata |
Department of Radiotherapy
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata
Kolkata
WEST BENGAL |
7417258805
shreshthvinaik2803@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Concurrent Chemo-Radiotherapy to treat Head and Neck Squamous Cell Carcinoma |
EBRT with 2 Grey per fraction, one fraction
per day, 5 days per week for 6.5 weeks (Monday to Friday) resulting in a total of
about 66 Grey with weekly Concurrent Chemotherapy with Inj. Cisplatin 40 mg/m2
. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
A. Patients willing to participate in the study by giving written consent.
B. Histopathologically proven Head and Neck Squamous cell carcinoma
C. Follows AJCC TNM Staging: will include T3 and T4 stages and/or N1-3 and M0
D. Adult patient (20 years to 70 years)
E. Performance status (ECOG 0-2)
F. Normal haematological parameters at the time of start of the treatment: Haemoglobin more than 10
gm/dL, Absolute Neutrophil Count (ANC) more than 1500/cu.mm., Platelet count more than 1L/cu.mm.
G. Normal biochemical blood parameters like Liver function test and Renal function test:
Liver enzymes (ALT/AST) less than 3UNL, Est. Creatinine Clearance more than 50
H. Patient willing to come for follow up. |
|
| ExclusionCriteria |
| Details |
1. Carcinoma of the Nasopharynx
2. Patients requiring Neoadjuvant Chemotherapy
3. Comorbidities, unrelated to the disease in study
4. Prior treatment with radiotherapy or surgery with curative intent for the disease under
study/ Recurrent disease
5. Any second primary or other malignancies within the last 5 years
6. Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the Impact of Treatment Interruption on overall disease response and Progression Free Survival of patients treated with Concomitant Chemo-Radiotherapy for Head and Neck Squamous Cell Carcinoma. |
3 weeks, 3 months, and then 3 monthly follow ups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the factors causing treatment interruption in Head & Neck Squamous Cell Carcinoma patient on Concomitant Chemo-Radiotherapy |
End of Treatment ie after the 45 day long standard Radiation Regime |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
27/12/2025 |
| 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="1"
Months="6"
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
|
The outcome We plan to reach with this research is to best find the impact of prolonged overall treatment time due to treatment interruptions in a planned RT schedule of HNSCC patients on the overall response and disease progression of the patients. We expect by this study to see that a delay in treatment will lead to poor outcomes in the patients. The poor outcomes that are caused by such RT delays in our setting will serve as a suggestion to find out the causes and remedy them, especially the easily avoidable factors. |