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NCT Number: NCT04809324

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tata Memorial Hospital, Mumbai, Maharashtra, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Multifocal disease
  • Clinically evident field cancerization
  • Previous treatment for oral cavity cancer - Surgery /chemo or radiotherapy -

Treatment and study plan

Gross examination of the resection specimen

Procedure

measurement of the surgical margin by the operating surgeon using sterile scale, margins <7mm will be revised on table

Frozen section

Procedure

frozen section evaluation of the specimen by the pathologist

Primary outcomes

  1. local recurrence free survival (LRFS) between two arms

    Time frame: 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 outcomes

  1. Accuracy of gross examination

    Time frame: 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.

  2. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GE and FS for the assessment of surgical margin

    Time frame: 5years

Study contacts

Contact information is provided by the study sponsor or research team.

Pankaj Chaturvedi, MS

CONTACT

[email protected]

+91 02224177189

Vidisha V Tuljapurkar, MS MCh

CONTACT

[email protected]

+91 02224177187

Sponsors and collaborators

Lead sponsor

Dr.Pankaj Chaturvedi

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Mar 22, 2021
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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