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

RecruitingPhase 3Ages 18 Years - 75 YearsAllAll India Institute of Medical Sciences, Jodhpur
NCT06737822 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
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.
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What it tests

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

7 sites
All India Institute of Medical Sciences, Bhubaneshwar
Bhubaneswar, India
All India Institute of Medical Sciences, Jodhpur
Jodhpur, India
All India Institute of Medical Sciences, Bathinda
Bathinda, India
Shri Mahant Indresh Hospital, Dehradun
Dehradun, India
King George's Medical University
Lucknow, India
All India Institute of Medical Sciences, Rishikesh
Rishikesh, India
Geetanjali Medical College, Udaipur
Udaipur, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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