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

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR · Dec 12, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether starting treatment with chemotherapy before surgery can improve outcomes for patients with advanced oral cancer. The researchers want to see if this approach leads to better disease-free survival—meaning patients live without signs of cancer for at least two years—compared to having surgery right away. They believe that patients with more aggressive forms of the disease may benefit the most from this chemotherapy-first strategy. The trial will also look at other important aspects, such as how well patients tolerate the treatment, any side effects they experience, and their overall quality of life.

To participate in this trial, patients must be newly diagnosed with operable oral squamous cell carcinoma that has spread to nearby lymph nodes (classified as N2 or N3). Eligible participants are adults aged 18 to 75 with good overall health and no serious medical conditions that would prevent them from receiving treatment, such as significant liver or kidney issues. Those who join can expect to receive either standard surgery followed by radiation or chemotherapy first, followed by surgery and then radiation. The study is actively recruiting participants, and those who take part will be closely monitored for up to five years to assess their health and treatment outcomes.

Gender

ALL

Eligibility criteria

• 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.