NCT06737822: SurVIC

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

Recruiting now Phase 3 Last updated 2 March 2025

What this trial tests

Phase 3 trial testing TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment in Oral Cancer in 346 participants. Currently enrolling.

Timeline

20 December 2024

Primary endpoint
1 October 2027

1 October 2029

Quick facts

Lead sponsor	All India Institute of Medical Sciences, Jodhpur
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	346
Start date	20 December 2024
Primary completion	1 October 2027
Estimated completion	1 October 2029
Sites	7 locations across India

Drugs / interventions tested

• TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment
• Surgery and Adjuvant Treatment

Conditions studied

• Oral Cancer — all drugs for Oral Cancer →
• Head and Neck Neoplasms — all drugs for Head and Neck Neoplasms →

Sponsor

All India Institute of Medical Sciences, Jodhpur

Who can join

Adults 18 to 75, any sex, with Oral Cancer or Head and Neck Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Disease Free Survival
  Time frame: 2 Years
  Date of randomization to the date of clinical or pathological evidence of recurrence

Sponsor's own description

A majority of oral cancer patients in India present in the advanced stage hence tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers but its role in oral cancer is not well defined in curative setting apart from radio sensitization. Attempted trials of neoadjuvant chemotherapy failed to show oncological advantage despite an excellent response rate, in part due to poor patient selection. Patients with a biologically aggressive disease are more likely to benefit, hence we intend to find out the oncological advantage of adding induction chemotherapy to oral squamous cell cancer with advanced nodal disease (N2-N3).

Earlier studies suffered from their heterogeneous patient population- all head and neck subsites together and included a spectrum ranging from early- stage operable cases to inoperable cancer. Due to such patient selection, the intended results were never met. The current study is intended to study the role of chemotherapy in curable patients who are most likely to benefit (biologically aggressive and advanced stage of presentation).

Objective

Primary:

To study the 2 year disease free survival by adding induction chemotherapy before surgery in patients of oral cancer with advanced nodal disease as compared to upfront surgery.

Secondary:

To assess treatment related outcomes between the treatment arms- Response rate; Treatment compliance; treatment related toxicity, postoperative complications and Quality of life.

To study the overall survival at 2 years. Oral cancer tissue biobanking for future translational research.

Study population Operable Oral cavity Squamous cell carcinoma with advanced nodal disease (N2-N3) Study Design Open label, Multi centric, randomized controlled trial with allocation ratio of 1:1

Sample Size The primary end point is disease-free survival. In order to have 80% power to detect a hazard ratio of 0.67, using a two-sided significance level, a total of 184 events are needed. Assuming an accrual rate of 15 patients a month, 300 patients need to be recruited. The analysis of DFS will take place 32 months after the start of the trial. The follow-up of patients will continue for 5 years. The analysis of OS will be conducted when 184 deaths are observed. taking 10% of withdrawal of consent, a total of 346 patients need to be included.

Inclusion Criteria Biopsy proven, operable oral Squamous cell carcinoma cT1-T4; cN2-N3, with adequate organ function, Age- 18-75 years, ECOG-PS:0-2 Treatment Arms

Standard Arm (SURG arm):

Surgery (Wide local Excision/composite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy

Experimental Arm (ICT):

2# TPF or TPX based induction chemotherapy followed by Surgery (Wide local Excision/composite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy

Study endpoints Primary- Disease free survival Secondary- Overall survival/ Quality of life/ Toxicity of treatment/ Treatment tolerance

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Upfront surgery versus induction chemotherapy followed by surgery in oral cavity squamous cell cancers with advanced nodal disease (SurVIC Trial): a phase 3 multicentre randomised controlled trial.
   Poonia DR, Sehrawat A, Vishnoi JR, Sharma N, et al · · 2025 · PMID 41057182 · DOI 10.1136/bmjopen-2025-106644