| CTRI Number |
CTRI/2025/08/093784 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| 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
|
Study to evaluate acute toxicity in postoperative head and neck cancer patients undergoing radiotherapy |
|
Scientific Title of Study
|
Prospective trial to evaluate acute toxicity during post operative radiotherapy after flap reconstructive surgery in head and neck cancer patients undergoing volumetric modulated ARC therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF AMIT BAHL |
| Designation |
Professor |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
dept of radiotherapy and oncology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8219586371 |
| Fax |
|
| Email |
dramitbahl@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF AMIT BAHL |
| Designation |
Professor |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
dept of radiotherapy and oncology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8219586371 |
| Fax |
|
| Email |
dramitbahl@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF AMIT BAHL |
| Designation |
Professor |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
dept of radiotherapy and oncology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8219586371 |
| Fax |
|
| Email |
dramitbahl@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
Dept of radiotherapy and oncology, PGIMER CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kriti Dhiman |
Postgraduate Institute Of Medical Education And Research |
Department of Radiation Oncology, PGIMER Chandigarh
Chandigarh
CHANDIGARH |
8219586371
kritidhiman34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, intramural |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C04||Malignant neoplasm of floor of mouth, (3) ICD-10 Condition: C03||Malignant neoplasm of gum, (4) ICD-10 Condition: C00||Malignant neoplasm of lip, (5) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP |
Control group will receive postoperative radiotherapy to surgical flap using single dose prescription volume PTV60Gy |
| Intervention |
INTERVENTION GROUP |
Study group will receive Postoperative Radiotherapy to surgical flap using two dose prescription volume PTV60Gy and PTV54Gy. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Biopsy proven Squamous cell carcinoma of oral cavity and paranasal sinus.
2.Adult patients undergoing surgery with flap reconstruction and post operative radiotherapy.
3.Patients requiring post operative radiotherapy for any of the following indications:
T3N0M0, T1-3N1,2M0, T4aN2M0, AnyTN3M0 disease.
4.Patient requiring postoperative radiotherapy due to positive margin, close margin, extra nodal extension in Post Operative Histopathology Report.
Patients giving written consent for study and follow up |
|
| ExclusionCriteria |
| Details |
1.Patient being treated for recurrent head and neck cancer.
2.Patient with uncontrolled comorbidities like diabetes mellitus and hypertension.
3.Previous history of undergoing head and neck radiotherapy. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate acute toxicity (mucositis, dysphagia, dermatitis, xerostomia, dysgeusia, anorexia, nausea, vomiting, pain) of postoperative radiotherapy between SIB- VMAT and non SIB- VMAT treatment technique during treatment and at 3 months follow up.
|
1.During treatment
2. At 3 months follow up.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate incidence of flap complications- infection, mild dehiscence, bone exposure, fistula, hematoma, partial flap loss, complete flap loss)between SIB- VMAT and non SIB- VMAT treatment technique during treatment and at 3 months follow up.
2. To evaluate disease recurrence between the study groups at a minimum of three months follow up.
|
At 3 months follow up |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 current practice of Post operative radiotherapy in Head and Neck cancer involves radiation of the entire flap in treatment portal. This leads to a considerable increase in radiotherapy treatment volume. As a consequence, there is significant acute toxicity associated with treatment and associated flap changes. Recent literature and guidelines have recommended to include only the flap junctional area in high-risk treatment volume. The rest of flap can be included in the low dose radiotherapy treatment volume. |