Health Condition 1: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
Intervention1: ICT arm: 2 Cycle of chemotherapy followed by surgery
2 Cycles of Induction chemotherapy at 3 weekly intervals with the dose schedule- Inj. Docetaxel 75mg/m2 IV Over 60 minutes Day-1
Inj. Cisplatin 75mg/m2 IV Over 60 minutes Over 60 minutes Day-1
Inj. 5 FU 850-1000mg/m2 IV Over 12 hours on Day1 to Day4 with GCSF/Peg-GCSF Support.
Replacement of infusional 5FU with Tab. Capecitabine 850-1000mg/m2 twice a day for 14 days in a three weekly cycle
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
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
Exclusion criteria
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, or Patients with known HIV, hepatitis B or C infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 2 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess treatment related outcomes between the treatment arms- Response rate; Treatment compliance; treatment related toxicity, postoperative complications & Quality of life.Timepoint: 3 Months;To study the overall survival at 2 years.Timepoint: 2 Years;Oral cancer tissue biobanking for future translational research.Timepoint: NA | — |
Countries
India
Contacts
Public ContactDharma Ram Poonia
AIIMS Jodhpur
Outcome results
None listed