Comparing upfront surgery and chemotherapy followed by surgery for oral cancer

Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cavity Squamous Cell Cancers With Advanced Nodal Disease (SurVIC Trial): A Phase 3 Multicentric Randomized Controlled Trial

This study is testing if starting with chemotherapy before surgery can help people with advanced oral cancer do better than having surgery right away.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: All India Institute of Medical Sciences, Jodhpur (Government)
• Drugs / interventions: Chemotherapy
• Locations: 7 sites (Bhubaneswar, Odisha and 6 other locations)
• Trial ID: NCT06737822 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of induction chemotherapy followed by surgery in patients with advanced oral squamous cell carcinoma (OSCC) compared to immediate surgery. The study focuses on patients with clinically staged N2-N3 disease, who are typically at a higher risk for poor outcomes. By selecting a more homogeneous patient population, the trial seeks to determine if the addition of chemotherapy can improve oncological outcomes. The treatment regimen includes TPF or TPX chemotherapy followed by surgical intervention and adjuvant treatment.

Who should consider this trial

Good fit: Ideal candidates are newly diagnosed, treatment-naïve patients with biopsy-proven OSCC at clinical stages cT1-4a and cN2-N3.

Not a fit: Patients with distant metastases, significant weight loss, or those with certain comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and better treatment outcomes for patients with advanced oral cancer.

How similar studies have performed: Previous studies on neoadjuvant chemotherapy in head and neck cancers have shown mixed results, indicating that this approach is still being explored for its potential benefits.

Eligibility criteria

Inclusion Criteria:

* Newly diagnosed, treatment naïve, biopsy or cytology proven OSCC
* Clinical Stage cT1-4a, cN2-N3\*\*, M0- as per UICC 2018
* No evidence of distant metastases on chest x-ray and/or CT Thorax
* ECOG PS 0-2
* No contraindication to Cisplatin or radiotherapy\*\*\*
* Patients eligible for definitive curative intent treatment after discussion in multidisciplinary tumour board
* Adequate organ function at time of participation, defined as Haematological: Haemoglobin \> 9gm/dl, ANC ≥ 1500/cmm3, Platelet ≥100000/cmm3 Liver Function test: Bilirubin ≤2 x upper limit normal (ULN), AST/ALT/ ALP ≤ 2.5 x ULN Renal Function test: Creatinine ≤ 1.5 ULN, Creatinine Clearance ≥60 ml/min.

Exclusion Criteria:

* Pregnant
* History of moderate to severe hearing loss.
* History of previous malignancy excluding non-melanoma skin cancers or cervical carcinoma in situ.
* Documented Weight loss of more than 15% in the last 6 months.
* Patients with known HIV, hepatitis B or C infection.

Where this trial is running

Bhubaneswar, Odisha and 6 other locations

• All India Institute of Medical Sciences, Bhubaneshwar — Bhubaneswar, Odisha, India (Not_yet_recruiting)
• All India Institute of Medical Sciences, Jodhpur — Jodhpur, Rajasthan, India (Recruiting)
• All India Institute of Medical Sciences, Bathinda — Bathinda, India (Not_yet_recruiting)
• Shri Mahant Indresh Hospital, Dehradun — Dehradun, India (Not_yet_recruiting)
• King George's Medical University — Lucknow, India (Not_yet_recruiting)
• All India Institute of Medical Sciences, Rishikesh — Rishikesh, India (Not_yet_recruiting)
• Geetanjali Medical College, Udaipur — Udaipur, India (Not_yet_recruiting)

Study contacts

• Principal investigator: Dharma R Poonia, MS DNB — AIIMS Jodhpur
• Study coordinator: Dharma R Poonia, MS DNB

Conditions Oral Cancer; Head and Neck Neoplasms