Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cancers:

NCT06737822 | Recruiting Phase 3 DMC

• 1 other identifier: 2023/5784
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Oral Cancer; Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  Date of randomization to the date of clinical or pathological evidence of recurrence

  2 Years

Secondary Outcomes (9)

• Overall Survival

  2 Years

• Treatment Completion Rate

  2 Years

• Treatment Related Toxicity

  2 Years

• Quality of Life using PROs

  3 Months; 6 Months; 12 Months; 18 Months; 24 Months; 36 Months; 48 Months; 60 Months

• Postoperative Surgical Morbidity

  30 Days and 90 Days

Study Arms (2)

Surg Arm

ACTIVE COMPARATOR

Wide Local Excision (WLE) with Comprehensive neck dissection Adjuvant Treatment as per current standard Guidelines

Combination Product: Surgery and Adjuvant Treatment

ICT Arm

EXPERIMENTAL

2# of Chemotherapy before the Stadrard Surery: Either TPF or TPX Wide Local Excision (WLE) with Comprehensive neck dissection Adjuvant Treatment as per current standard Guidelines

Combination Product: TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment

Interventions

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

TPF: IINJ DOCETAXEL 75mg/M2 in 500 ML NORMAL SALINE(PVC free container/glass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG/M 2 IN 500 ML NS IV OVER 1 HOUR ON DAY1 ONLY INJ. 5FU 750 MG/M2 IV THROUGH INFUSION PUMP OVER 24 HOURS D 1-4 Or TPX Regimen INJ DOCETAXEL 75mg/M2 in 500 ML NORMAL SALINE(PVC free container/glass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG/M 2 IN 500 ML NS IV OVER 1 HOUR ON D1 ONLY TAB. CAPECITABINE 850-1000MG/M2 TWICE A DAY 30 MINUTES AFTER MEALS FOR 14 DAYS IN A THREE WEEKLY CYCLE Surgery and Adjuvant Treatment Patients with PR/CR or SD will go for surgical resection. Patients having PD but still localized and resectable will be offered surgical resection, other would undergo radical CTRT or Palliative Treatment.

ICT Arm

Surgery and Adjuvant Treatment COMBINATION_PRODUCT

Wide Local Excision (WLE) with Comprehensive neck dissection and Adjuvant Treatment as per current standard Guidelines.

Surg Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Jodhpur: lead
• All India Institute of Medical Sciences, Rishikesh: collaborator
• All India Institute of Medical Sciences, Bhubaneswar: collaborator
• All India Institute of Medical Sciences, Bathinda: collaborator
• King George's Medical University: collaborator
• Shri Mahant Indiresh Hospital, Dehradun: collaborator
• Geetanjali Medical College, Udaipur: collaborator

Study Sites (7)

All India Institute of Medical Sciences, Bhubaneshwar

Bhubaneshwar, Orisa, 751019, India

NOT YET RECRUITING

All India Institute of Medical Sciences, Jodhpur

Jodhpur, Rajasthan, 342005, 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

Related Publications (1)

• Poonia DR, Sehrawat A, Vishnoi JR, Sharma N, Kumar P, Devnani B, Warriere A, Solanki A, Pareek P, Aggarwal D, Yadav T, Sharma PP, Gadwal A, Goyal A, Elhence P, Khera P, Jakhetiya A, Swaim P, Muduly D, Mahajan R, Garg P, Kumar V, Kar M, Misra S. 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. BMJ Open. 2025 Oct 6;15(10):e106644. doi: 10.1136/bmjopen-2025-106644.

  PMID: 41057182 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms; Head and Neck Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dharma R Poonia, MS DNB

  AIIMS Jodhpur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dharma R Poonia, MS DNB

CONTACT

9958654196; pooniadr@aiimsjodhpur.edu.in

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator & Associate Professor Surgical Oncology

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: December 17, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (7)