Comparing gross examinations and frozen sections for surgical margins in oral cancers
Intra-operative Gross Examination Versus Frozen Section for Achievement of Adequate Margin in Patients Undergoing Surgery for Oral Cavity Squamous Cell Carcinoma: A Randomized Controlled Trial
This study is testing whether using frozen section analysis during surgery helps patients with oral cancer have better outcomes compared to just looking at the tissue with the naked eye.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1206 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Locations | 3 sites (Mumbai, Maharashtra and 2 other locations) |
| Trial ID | NCT04809324 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of gross examination versus frozen section analysis for assessing surgical margins in patients with oral cavity squamous cell carcinoma (OCSCC). It aims to determine whether the use of frozen section, which is often employed to ensure adequate margins during surgery, actually improves oncological outcomes compared to gross examination alone. The study will include treatment-naïve patients scheduled for curative surgery and will assess the cost-effectiveness of frozen section procedures in resource-limited settings. The findings could provide insights into the best practices for surgical management of OCSCC.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve adults over 18 years old with biopsy-proven OCSCC planned for curative surgery.
Not a fit: Patients with multifocal disease or those who have previously received treatment for oral cavity cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective surgical practices and potentially better outcomes for patients with oral cavity cancer.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of frozen section analysis in improving surgical outcomes, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Biopsy proven treatment naïve cases of OCSCC who are planned for curative surgery with en-bloc removal of the tumor with adequate margin 2. In detail assessment of the primary tumor is possible pre-operatively 3. Written informed consent 4. Age more than 18 years Exclusion Criteria: 1. Multifocal disease 2. Clinically evident field cancerization 3. Previous treatment for oral cavity cancer - Surgery /chemo or radiotherapy -
Where this trial is running
Mumbai, Maharashtra and 2 other locations
- Tata Memorial Hospital — Mumbai, Maharashtra, India (Recruiting)
- ACTREC,Advanced Centre for Treatment, Research and Education in Cancer — Navi Mumbai, Raigad, India (Recruiting)
- Mahamana Pandit Madan Mohan Malaviya Cancer Centre — Varanasi, Uttar Pradesh, India (Recruiting)
Study contacts
- Principal investigator: Pankaj Chaturvedi, MS — Tata Memorial Centre
- Study coordinator: Pankaj Chaturvedi, MS
- Email: chaturvedi.pankaj@gmail.com
- Phone: +91 02224177189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.