Study of surgery verses study of chemotherapy and radiation therapy in a patients with oral cancer
- Conditions
- Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified
- Registration Number
- CTRI/2021/07/034990
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Histopathology proven diagnosis of squamous cell carcinoma of the oropharynx, localized to the tonsil and /or lateralized tongue-base
2. ECOG Performance Status <=2
3. Age >=18 to 70 years
4. Anesthetic fitness obtained for surgery under general anesthesia
5. Resectable primary tumor with an anticipation of achieving resection free margins either by minimally invasive/open techniques
6. Clinical stage III or IV, i.e. T1 T2 or T3 -T4 with N0-N3.
Nodal disease with extranodal extension on clinical examination/
imaging may be included at the surgeonâ??s discretion, if the nodal disease is deemed resectable by the operating surgeon
7. HPV negative status determined by p16 status
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. Patients with no contraindications to Cisplatin chemotherapy
and radiotherapy
10. Adequate organ function
a. Hematological- Hb > 10 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.
b. Liver functions - bilirubin <= 2 x upper limit normal (ULN), AST/ALT/ALP <= 2.5 x ULN, S. albumin >= 30 g/L.
c.Renal function - Creatinine <= 1.5 ULN, Creatinine clearance > 50 mL/min.
11. Women of child bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial
12. Patients who can be followed up and must be able to provide informed consent prior to study entry
1. Prior head and neck malignancy
2. Prior invasive malignancy, unless disease free for a minimum of 3 years
3. Prior chemotherapy for a different cancer administered
within 3 years prior to registration
4. Patients who have received any neoadjuvant/ induction chemotherapy
5. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation therapy fields
6. Unresectable primary or nodal disease involving the carotid vessels, prevertebral fascia or skull base
7. Large soft palate involvement >1 cm 8. Deep extension into larynx,
pre-epiglottic space and deep invasion into extrinsic
muscles of tongue
9. Calculated GFR < 50 cc/min
10.Patients who have uncontrolled cardiac
co morbidity
a.QTc prolongation (a value of >450 milliseconds)
b.Ejection fraction below 50%
c.Presence of regional wallakinesia
11. Presence of previous episode of thrombosis or embolism or presence of a prothrombotic condition in last 1 year
12. Presence of severe malnutrition as defined by body mass index of below 16kg per m2 or presence of weight loss of greater than 20% in la
st 6 months
13. Severe active comorbidities such as severe cardiac failure, severe pulmonary compromise, type 1or 2 diabetes mellitus (Hb1ac of > 8 mg/dl) severe and active infections or life expectancy less than 6 months
14. Prior allergic reaction to cisplatin
15. Radiographic evidence of retropharyngeal and/or level VI metastasis
16. Patients on other investigational drugs within last 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method