| CTRI Number |
CTRI/2025/05/087040 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to find out whether patients with initial stage of mouth cancer do better if they undergo surgery followed by radiation compared to just undergoing surgery alone. |
|
Scientific Title of Study
|
Ascertaining the impact of adjuvant radiotherapy in early stage risk factor positive oral cavity squamous cell carcinoma and evaluating patterns of failure
A project of the
Young Investigators Committee under the auspices of the Head and Neck Inter Group |
| Trial Acronym |
PORTHES-OC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monali Swain |
| Designation |
Professor, Radiation Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1117 11th Floor Homi Bha Bha Block Building Tata
Mmeorial Hospital Parel Room No 205 2nd Floor Department of
Radiation Oncology Homi Bha Bha Block Building Tata Mmeorial
Hospital Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920739863 |
| Fax |
|
| Email |
drmonaliswain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monali Swain |
| Designation |
Professor, Radiation Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1117 11th Floor Homi Bha Bha Block Building Tata
Mmeorial Hospital Parel Room No 205 2nd Floor Department of
Radiation Oncology Homi Bha Bha Block Building Tata Mmeorial
Hospital Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920739863 |
| Fax |
|
| Email |
drmonaliswain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monali Swain |
| Designation |
Professor, Radiation Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1117 11th Floor Homi Bha Bha Block Building Tata
Mmeorial Hospital Parel Room No 205 2nd Floor Department of
Radiation Oncology Homi Bha Bha Block Building Tata Mmeorial
Hospital Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920739863 |
| Fax |
|
| Email |
drmonaliswain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai,India 400012 |
|
|
Primary Sponsor
|
| Name |
University of Oklahoma |
| Address |
660 Parrington Oval Norman OK 73019 United States |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Princess Alexandra Hospital |
199 Ipswich Rd Woolloongabba QLD 4102 Australia |
| Tata Memorial Hospital |
Dr E Borges Marg Parel Mumbai India |
| University of Florence |
P za di San Marco 4 50121 Firenze FI Italy |
|
|
Countries of Recruitment
|
India
United States of America
Australia
Italy |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monali Swain |
Tata Memorial Hospital |
Room No 1117, Department of Radiation Oncology, Head and Neck Disease Management group,
Dr. E Borges Marg
Parel
400012
Mumbai
MAHARASHTRA |
9920739863
drmonaliswain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D||Radiation Therapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Treated for early-stage (cT1-2N0M0) oral cavity cancer
They must have been treated with curative intent via surgery, with or without adjuvant therapies
Must have had at least two years of follow-up, or death
|
|
| ExclusionCriteria |
| Details |
Patients who are being treated for recurrence (either palliatively or by salvage surgery) or for distant metastasis at presentation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall Survival between radiation and no radiation groups.
Overall Survival between radiation and no radiation groups in patients with WPOI V
|
3 year, 5 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recurrence rates between radiation & no radiation groups.
Patterns of recurrence
|
At 2 years |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="200"
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)
|
25/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/06/2024 |
| 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)
|
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 purpose of this retrospective study is to investigate the difference in disease outcomes of patients who were treated with surgery plus adjuvant radiotherapy versus surgery alone for early-stage oral cavity squamous cell carcinoma (OC-SCC) with various risk factors. Currently, surgery is often used as the sole treatment modality of choice for patients with stage I and II OC-SCC. However, certain poor pathological features, such as higher worst pattern of invasion (WPOI), perineural invasion, and lymphovascular invasion, are associated with worse tumor biology and increase the risk of local recurrence, even in the early stages of oral cavity cancer. We seek to investigate whether patients with such high-risk features stand to gain benefit by receiving post-operative radiation therapy (PORT) in an effort to lower the risk of local recurrence, and potentially to improve overall survival. We also seek to learn more about patterns of spread, such as whether particular pathological features increase the chance of contralateral neck nodal failure |