Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Hyperthermic intracavitary cispaltin: Intraoperative procedure
Once the surgery is performed, complete visual haemostasis is checked and confirmed with Valsalva maneuverer. All instrume
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to understand the procedure and willingness to sign an informed consent 2. ECOG Performance Status 2 3. Age 18 years old, up to 65 years old 4. Histopathology proven diagnosis of squamous cell carcinoma 5. Surgically resectable Stage III/IV oral cancer, as per the multidisciplinary discussion 6. Primary tumor should be lateralised so as to not require bilateral neck dissection 7. Nodal disease with/without extranodal extension on clinical examination/imaging 8. No distant metastases below the clavicles, based upon the following minimum diagnostic workup: a. History/physical examination by the physician b. Imaging of the head and neck (Contrast enhanced MRI for local workup and Chest CT/PET-CT for distant metastatic workup) 9. Fit for major surgery, American Society of Anesthesiologists ASA 1/2 10. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2 11. Adequate organ function 12. Patients with no contraindications to Cisplatin chemotherapy and radiotherapy 13. Women of child bearing age should not be pregnant at the time of enrolment and should be willing to use adequate contraception during the treatment phase
Exclusion criteria
Exclusion criteria: 1. History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel 2. Prior invasive malignancy, unless disease free for a minimum of 3 years, with the exception of radically excised basal cell 3. Prior chemotherapy for a different cancer administered within 3 years prior to registration 4. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation therapy fields 5. Unresectable primary or nodal disease involving the carotid vessels, prevertebral fascia or skull base 6. Calculated GFR less 50 cc/min 7. Patients who have uncontrolled cardiac comorbidity 8. Presence of previous episode of thrombosis or embolism or presence of a prothrombotic condition in last 1 year 9. Presence of severe malnutrition 10. Severe active co-morbidities 11. Radiographic evidence of retropharyngeal and or level VI metastasis 12. Patients on other investigational drugs within last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicities (DLTs) from the procedureTimepoint: At baseline; 30 days post-surgery; at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine patterns of locoregional failure and survival outcomesTimepoint: 2 year;2. To determine the compliance for treatment optionsTimepoint: immediate;3. To determine distribution of HICOC in systemic circulationTimepoint: upto day 2 | — |
Countries
India
Contacts
Public ContactArjun Singh
TATA MEMORIAL CENTRE
Outcome results
None listed