Compares two ways of checking surgical edges during oral cancer removal
Compares surgeon visual checks with frozen section tests on tissue edges in oral cancer surgery.
Plain-language title generated from the registry record
Registry title: Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers
Key facts
- Where
- Mumbai, Navi Mumbai, and Varanasi, IndiaSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT04809324, who can take part
Where in India
- Tata Memorial HospitalMumbai, IndiaTaking people
- ACTREC,Advanced Centre for Treatment, Research and Education in CancerNavi Mumbai, IndiaTaking people
- Mahamana Pandit Madan Mohan Malaviya Cancer CentreVaranasi, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Dr.Pankaj Chaturvedi
- Trial code
- NCT04809324
- Record updated
- 11 April 2025
- Original description
Surgical margin is a significant prognostic factor in oral cavity squamous cell carcinoma (OCSCC)[1,2,3]. Intra-operative frozen section (FS) has been routinely used by the surgeons to achieve adequate surgical margins. However published literature has failed to show a conclusive benefit of FS in improving oncological outcomes(4-7). The overall identification rate of the inadequate margins by FS is variable with figures in the literature ranging from25-34%.(8-10)Read full original descriptionShow less
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
Surgical margin is a significant prognostic factor in oral cavity squamous cell carcinoma (OCSCC)[1,2,3]. Intra-operative frozen section (FS) has been routinely used by the surgeons to achieve adequate surgical margins. However published literature has failed to show a conclusive benefit of FS in improving oncological outcomes(4-7). The overall identification rate of the inadequate margins by FS is variable with figures in the literature ranging from25-34%.(8-10)
Revision of margins based on FS is widely practiced in centers where facility for FS is available. However this has not shown to significantly improve local control when compared to cases in which FS was not utilized , in a comparative study done at Tata memorial Hospital(TMH) (5) More-over FS is a costly procedure, and sparsely available in resource- poor countries. In a recently conducted retrospective study of 1237 patients conducted at TMH, the cost benefit ratio of FS for assessment of margin is as low as 12:1(11). In another prospective study performed at the same center , investigators found that gross examination (GE) of margins by the surgeons was as effective as FS, and achievement of gross 7mm margin all around the tumor obviated the need for FS (12). In a recent meta-analysis of 8 studies that looked at the utility of frozen section and had uniformity in frozen section analysis and definition of close margins, they concluded that revision of margins based on FS does not improve oncological outcomes and further prospective studies are needed to explore this contentious issue (13). With this background, a prospective RCT is planned to explore if gross examination by surgeon and subsequent revision of margin (if necessary) is an equally effective alternative to Frozen section based revision in a randomized controlled trial.
Inclusion: Biopsy proven treatment naïve cases of OCSCC who are planned for curative surgery with en-bloc removal of the tumor with adequate margin; In detail assessment of the primary tumor is possible pre-operatively; Written informed consent; Age more than 18 years.
Exclusion: Previous treatment for oral cavity cancer - Surgery /chemo or radiotherapy -; Multifocal disease; Clinically evident field cancerization.