Comparing upfront surgery and chemotherapy followed by surgery for oral cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• All India Institute of Medical Sciences, Jodhpur
  Jodhpur, Rajasthan, India Recruiting
• All India Institute of Medical Sciences, Bhubaneshwar
  Bhubaneswar, Odisha, India Not yet 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

Study contacts

• Principal investigator: Dharma R Poonia, MS DNB — AIIMS Jodhpur
• Study coordinator: Dharma R Poonia, MS DNB
• Email: pooniadr@aiimsjodhpur.edu.in
• Phone: 9958654196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.