{
  "abstract": "Introduction Most oral cancers in India present in advanced stages and tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers, but its role in oral cancer is still not well-defined in curative settings beyond radiosensitisation. Despite an excellent response rate, neoadjuvant chemotherapy trials have failed to show an oncological advantage. Earlier studies were limited by their heterogeneous patient population, including all head and neck subsites, and included both inoperable cancer and early-stage operable cases. Due to such patient selection, the intended results were never met. Patients with biologically aggressive diseases (advanced nodal disease) may derive greater benefit from induction chemotherapy (ICT). Therefore, we aim to determine the oncological advantage of adding ICT to oral squamous cell cancer with advanced nodal disease (N2–N3).Methods and analysis The study is an open-label, multicentre, randomised controlled trial, with an allocation ratio of 1:1, being conducted at seven leading cancer centres in India. The primary objective is to compare survival outcomes with and without ICT before surgery in patients with oral squamous cell carcinoma (OSCC) and advanced nodal disease, specifically focusing on 2-year disease-free survival (DFS). Secondary objectives include assessing overall survival (OS), clinical and pathological response rates, treatment compliance, treatment completion rates, adverse events, treatment-related toxicity (using Common Terminology Criteria for Adverse Events, V.5.0), quality of life (measured with Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Head and Neck) and postoperative complications (using the modified Clavien-Dindo classification).The study population consists of patients with operable OSCC and advanced nodal disease (N2–N3), adequate organ function, aged 18–65 years and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2. The treatment arms are the standard arm Surgery arm (SURG), which involves surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, and the experimental arm (ICT), in which patients will receive two cycles of ICT using either cisplatin, docetaxel and 5-fluorouracil or cisplatin, docetaxel and capecitabine, followed by surgery and adjuvant radiotherapy with or without concurrent chemotherapy. The sample size was calculated to detect an HR of 0.67 with 80% power. A total of 184 events are required, and with an accrual rate of 15 patients per month, 300 patients will be recruited. DFS analysis will occur 32 months after the trial begins, and follow-up will continue for 5 years. OS analysis will be conducted when 184 deaths are observed. Taking 10% of the withdrawal of consent, a total of 346 patients need to be included.Ethics and dissemination This trial aims to establish the potential superiority of ICT or definitively determine its futility in OSCC with advanced nodal disease. A positive outcome could provide practice-changing data, particularly for Indian patients, whereas negative results could halt the use of ICT in this setting, directing research efforts towards more effective treatment strategies.Trial registration number CTRI/2024/03/064586; NCT06737822; Institutional Ethics Committee (IEC) number: AIIMS/IEC/2023/4622 (lead site).",
  "authors": [
    {
      "affiliations": [
        "Department of Surgical Oncology, AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Dharma Ram Poonia"
    },
    {
      "affiliations": [
        "Medical Oncology, AIIMS Rishikesh, Rishikesh, Uttarakhand, India"
      ],
      "name": "Amit Sehrawat"
    },
    {
      "affiliations": [
        "Department of Surgical Oncology, AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Jeewan Ram Vishnoi"
    },
    {
      "affiliations": [
        "AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Nivedita Sharma"
    },
    {
      "affiliations": [
        "Medical Oncology, AIIMS Jodhpur, Jodhpur, India"
      ],
      "name": "Parmod Kumar"
    },
    {
      "affiliations": [
        "AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Bharti Devnani"
    },
    {
      "affiliations": [
        "Surgical Oncology, Homi Bhabha Cancer Hospital and Research Centre, Visakhapatnam, Andhra Pradesh, India"
      ],
      "name": "Aparna Warriere"
    },
    {
      "affiliations": [
        "AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Akanksha Solanki"
    },
    {
      "affiliations": [
        "AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Puneet Pareek"
    },
    {
      "affiliations": [
        "AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Divya Aggarwal"
    },
    {
      "affiliations": [
        "AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Taruna Yadav"
    },
    {
      "affiliations": [
        "Department of Community Medicine and Family Medicine, All India Institute of Medical Sciences, New Delhi, Delhi, India"
      ],
      "name": "Prem Prakash Sharma"
    },
    {
      "affiliations": [
        "Department of Surgical Oncology, AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Ashita Gadwal"
    },
    {
      "affiliations": [
        "AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Anushka Goyal"
    },
    {
      "affiliations": [
        "All India Institute of Medical Sciences, New Delhi, India"
      ],
      "name": "Poonam Elhence"
    },
    {
      "affiliations": [
        "AIIMS Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Pushpinder Khera"
    },
    {
      "affiliations": [
        "Surgical Oncology, Geetanjali University, Geetanjali Medical College and Hospital, Udaipur, India"
      ],
      "name": "Ashish Jakhetiya"
    },
    {
      "affiliations": [
        "Surgical Oncology, AIIMS Bhubaneswar, Bhubaneswar, Odisha, India"
      ],
      "name": "Pnahindra Swaim"
    },
    {
      "affiliations": [
        "Surgical Oncology, AIIMS Bhubaneswar, Bhubaneswar, Odisha, India"
      ],
      "name": "Dillip Muduly"
    },
    {
      "affiliations": [
        "Radiation Oncology, AIIMS Bathinda, Bathinda, Punjab, India"
      ],
      "name": "Rohit Mahajan"
    },
    {
      "affiliations": [
        "Surgical Oncology, Shri Mahant Indiresh Hospital, Dehradun, Uttarakhand, India"
      ],
      "name": "Pankaj Garg"
    },
    {
      "affiliations": [
        "King George's Medical University, Lucknow, Uttar Pradesh, India"
      ],
      "name": "Vijay Kumar"
    },
    {
      "affiliations": [
        "Surgical Oncology, AIIMS Darbhanga, Darbhanga, Bihar, India"
      ],
      "name": "Madhabananda Kar"
    },
    {
      "affiliations": [
        "Department of Surgical Oncology, All India Institute of Medical Sciences Jodhpur, Jodhpur, Rajasthan, India"
      ],
      "name": "Sanjeev Misra"
    }
  ],
  "title": "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",
  "uid": "89301b19-020d-55f3-b383-caa7b2bc8861"
}