| CTRI Number |
CTRI/2025/03/082472 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Weekly versus 3 weekly chemotherapy along with concurrent Radiotherapy in oral cavity cancer |
|
Scientific Title of Study
|
A prospective evaluation of weekly versus 3 weekly cisplatin for adjuvant chemoradiotherapy in oral cavity cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunav Basu Biswas |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department of Radiotherapy and Radiation Medicine, Sir Sunderlal Hospital, Institute of Medical Sciences, BHU.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7430911947 |
| Fax |
|
| Email |
meghbaba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Himanshu Mishra |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department of Radiotherapy and Radiation Medicine, Sir Sunderlal Hospital, Institute of Medical Sciences, BHU.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7704909900 |
| Fax |
|
| Email |
hmsra1801@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Himanshu Mishra |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department of Radiotherapy and Radiation Medicine, Sir Sunderlal Hospital, Institute of Medical Sciences, BHU.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7704909900 |
| Fax |
|
| Email |
hmsra1801@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiotherapy, Sir Sunderlal Hospital Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India. PIN-221005 |
|
|
Primary Sponsor
|
| Name |
institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Radiotherapy, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India. PIN- 221005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunav Basu Biswas |
Institute of Medical Sciences, Banaras Hindu University |
Department of Radiotherapy, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
7430911947
basubiswassunav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANARAS HINDU UNIVERSITY, INSTITUE OF MEDICAL SCIENCES, INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3 weekly chemoradiation |
For patients in 3 weekly chemoradiation arm, concurrent Cisplatin will be given once every 3 weeks at 100mg/sq. meter of body surafce area. For patients with impaired hearing function tests, Carboplatin at (AUC)5 will be given 3 weekly |
| Comparator Agent |
Weekly Chemoradiation |
For patients in weekly chemoradiation arm, concurrent Cisplatin will be given once a week at a dose of 40mg/sq.meter of body surface area, while for patients with impaired hearing function tests, Carboplatin at (AUC)2 will be given once weekly |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Post operative oral cavity carcinoma (AJCC Pathological group staging I-IVa)
2. Squamous cell carcinoma histology
3. High risk features like positive resection margin and/or Extracapsular extension
4. ECOG 0-1
5. Adequate hematologic, renal and hepatic function
6. Adequate creatinine clearance |
|
| ExclusionCriteria |
| Details |
1. Any synchronous or metachronous malignancy
2. Patients who received neo-adjuvant chemotherapy
3. Previous history of chemotherapy and/or radiotherapy for any other malignancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| loco-regional control |
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall Survival |
3 months
6 months |
| Disease Free Survival |
3 months
6 months |
| Acute Toxicity |
Weekly during chemoradiation,
upto 3 months of completion of chemoradiation |
| Late toxicity |
3 months
6 months |
| Quality of Life Assessment |
Before start of Chemoradiation,
After completion of Chemoradiation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/03/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [basubiswassunav@gmail.com].
- For how long will this data be available start date provided 01-12-2026 and end date provided 31-12-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In this study, the patients of oral cavity cancer due for adjuvant chemoradiotherapy(CRT), will be considered after applying suitable inclusion and exclusion criteria. Patients of both genders, age between 18 years to 65 years, ECOG 0-1 will be included having high risk features of margin positivity and/or extracapsular extension. Patient having prior history of malignancy, history of CRT or synchronous malignancies will be excluded. Patients will be randomized in two two arms by computer generated random number table. In one arm, along with radiation concurrent chemotherapy(CT) will be given weekly. In other arm, along with radiation, concurrent CT will be given 3 weekly. Patients will be given Cisplatin CT however patients having impaired hearing function tests, namely Pure Tone Audiometry (PTA)/ Impedance Audiometry (IA) will be given Carboplatin. In weekly arm, Cisplatin will be given at 40mg/sq. meter of body surface area weekly for 6 weeks and in 3 weekly arm, Cisplatin will be given at 100mg/sq. meter body surface area 3 weekly. For patients having impaired hearing function tests, in weekly arm Carboplatin will be given at (AUC)2 (Area Under Curve), while in 3 weekly arm Carboplatin will be given at (AUC)5. After that patients will be assessed to compare the locoregional control being the primary endpoint. And secondary end points being overall survival (OS), disease free survival (DFS), Acute toxicity, Late toxicity and Quality of Life assessment. |