Comparing gross examinations and frozen sections for surgical margins in oral cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.