Study of measurement of margins of area around tumour

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 - GROSS Vs FROZEN RCT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032015

Enrollment

1206

Registered

2021-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: gross examination: measurement of the surgical margin by the surgeon using sterile scale Control Intervention1: frozen section examination of the surgical margin: frozen section examina

Eligibility

Inclusion criteria

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 2. In detail assessment of the primary tumour is possible pre-operatively 3. Written informed consent 4. Age more than 18 years

Exclusion criteria

Exclusion criteria: 1. Multifocal disease 2. Clinically evident field cancerisation 3. Previous treatment for oral cavity cancer – Surgery /chemo or radiotherapy

Design outcomes

Primary

Measure	Time frame
To determine the difference between the local recurrence free survival (LRFS) between intra operative gross examination by the surgeon compared with microscopic examination of frozen sections by the pathologist for the assessment of surgical margin in patients undergoing surgery for OCSCC.Timepoint: 2 years	—

Secondary

Measure	Time frame
1.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 2. sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GE and FS for the assessment of surgical marginTimepoint: After 2 years	—

Countries

India

Contacts

Public ContactDr Vidisha Tuljapurkar

Tata Memorial Hospital

chaturvedi.pankaj@gmail.com02224177189

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026