Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers

Not Applicable

Recruiting

• Conditions: Oral Cavity Cancer
• Interventions: Procedure: Frozen section; Procedure: Gross examination of the resection specimen

• Registration Number: NCT04809324
• Lead Sponsor: Dr.Pankaj Chaturvedi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-22
• Study Start: 2021-11-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1206

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frozen section	Frozen section	frozen section examination of surgical margins will be done by the pathologist.
Gross examination	Gross examination of the resection specimen	measurement of the surgical margins will be done by the surgeon in the operating room using sterile scale after resection of the primary tumor .

Primary Outcome Measures

Name	Time	Method
local recurrence free survival (LRFS) between two arms	2 years	To determine the difference between the local recurrence free survival (LRFS) between intra operative gross examination by the surgeon compared with microscopic examination using frozen sections by the pathologist for the assessment of surgical margin in patients undergoing surgery for OCSCC.; Local recurrence will be defined as - tumor recurrence at the same subsite or or at margins of previous surgery \&/ reconstruction with or without nodal recurrence /distant metastases withing two years after completion of the treatment.; - Isolated regional \&/or distant metastasis without recurrence at local site will be recorded however it will not be considered as the event for measuring LRFS

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GE and FS for the assessment of surgical margin	5years
Accuracy of gross examination	5 years	To determine the accuracy of intra operative gross examination by the surgeon compared with microscopic examination of frozen sections by the pathologist for the assessment of surgical margin as compared to the final histopathology report as the gold standard.

Trial Locations

Locations (3)

Tata Memorial Hospital; 🇮🇳 Mumbai, Maharashtra, India

ACTREC,Advanced Centre for Treatment, Research and Education in Cancer; 🇮🇳 Navi Mumbai, Raigad, India

Mahamana Pandit Madan Mohan Malaviya Cancer Centre; 🇮🇳 Varanasi, Uttar Pradesh, India