NCT06737822 Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cancers:
| NCT ID | NCT06737822 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | All India Institute of Medical Sciences, Jodhpur |
| Condition | Oral Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 346 participants in total. It began in 2024-12-20 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Dharma R Poonia, MS DNB
PRINCIPAL INVESTIGATOR
AIIMS Jodhpur
Frequently Asked Questions
Who can join the NCT06737822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Oral Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06737822 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 346 participants.
Is NCT06737822 currently recruiting?
Yes, NCT06737822 is actively recruiting participants. Contact the research team at pooniadr@aiimsjodhpur.edu.in for enrollment information.
Where is the NCT06737822 trial being conducted?
This trial is being conducted at Bhubaneswar, India, Jodhpur, India, Bathinda, India, Dehradun, India and 3 additional locations.
Who is sponsoring the NCT06737822 clinical trial?
NCT06737822 is sponsored by All India Institute of Medical Sciences, Jodhpur. The principal investigator is Dharma R Poonia, MS DNB at AIIMS Jodhpur. The trial plans to enroll 346 participants.
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