Health Condition 1: null- Patient with Cancer of Gingivobuccal Complex
Conditions
Interventions
None listed
Sponsors
DBT
Eligibility
Inclusion criteria
Inclusion criteria: 1. Previously untreated borderline resectable GB SCC i.e T4a lesions 2. Histological proven diagnosis of squamous cell cancer 3. Signed informed consent 4. Adequate organ function • Hematological- Hb > 9 g/dL, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L. • Liver functions- bilirubin=30 g/L. • Renal function- Creatinine 30 mL/min. • Performance score (KPS) > 80 or ECOG
Exclusion criteria
Exclusion criteria: 1. Distant metastasis present 2. Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections. 3. Patients not suitable for any chemotherapy. 4. Patient is currently enrolled in a clinical trial for another investigational therapy. 5. Pregnancy 6. Patients in whom chemotherapy is advised for a palliative intent will not be considered for the study because chemotherapy will be very varied and may be metronomic in nature which will cause wide differences in the final analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| biomarkers to predict response to chemotherapyTimepoint: 1) Pre treatment: at the time of diagnosis 2) Post treatment: after 2 cycles of chemotherapy. 3) Post surgery: surgery is done in responders after 3 cycles of chemotherapy so, biopsy at surgery will be taken as third time point (post treatment). But in non responders 3rd cycle of chemotherapy is not given if they do not respond to the first two cycles of NACT | — |
Secondary
| Measure | Time frame |
|---|---|
| Identification of novel biomarkerTimepoint: 1) Pre treatment: at the time of diagnosis 2) Post treatment: after 2 cycles of chemotherapy. 3) Post surgery: surgery is done in responders after 3 cycles of chemotherapy so, biopsy at surgery will be taken as third time point (post treatment). | — |
Countries
India
Contacts
Public ContactDr Surajit Dhara
National Institute of Biomedical Genomics (NIBMG)
Outcome results
None listed