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.
- Conditions
- Radiation Therapy,
- Registration Number
- CTRI/2025/05/087040
- Lead Sponsor
- University of Oklahoma
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 1500
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.
Patients who are being treated for recurrence (either palliatively or by salvage surgery) or for distant metastasis at presentation.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival between radiation and no radiation groups. 3 year, 5 year Overall Survival between radiation and no radiation groups in patients with WPOI V 3 year, 5 year
- Secondary Outcome Measures
Name Time Method Recurrence rates between radiation & no radiation groups. Patterns of recurrence
Trial Locations
- Locations (1)
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Tata Memorial Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Monali SwainPrincipal investigator9920739863drmonaliswain@gmail.com