Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Tab.Capecitabine: Capecitabine tablet will be given for patients not eligible for cisplatin chemotherapy during radiation therapy
No comparator agent
Intervention2: Capecitabine based c
Sponsors
Cancer Institute WIA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Untreated squamous cell carcinoma of cervix who are planned for definitive chemoradiation 2. Cisplatin ineligible â?? Sensorineural hearing loss, Sensory/Motor neuropathy > grade 2, Borderline renal dysfunction (Calculated creatinine clearance > 30 - 60ml/min), or patientâ??s unwillingness to receive cisplatin/intravenous chemotherapy. 3. Eastern Cooperative Oncology Group performance status of 0, 1, or 2. 4. Adequate Aspartate transaminase (AST) and Alanine transaminase (ALT) within 3 times the upper limit of normal (ULN), serum bilirubin less than 2 mg/dL
Exclusion criteria
Exclusion criteria: 1. Preexisting coronary heart disease (Unstable angina, Echocardiography showing regional wall motion abnormalities or ejection fraction NYHA (Newyork Heart Association) class > 2 2. Known dihydropyramidine dehydrogenase (DPD) mutation 3. Creatinine clearance 4. Uncontrolled comorbid illness 5. Inflammatory bowel disease 6. Patient taking oral anti coagulants like warfarin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical treatment response of tumor using RECIST [Response Evaluation Criteria In Solid Tumors] criteria, 3 months after completion of radiation therapyTimepoint: Clinical Treatment Response assessment will be done at completion of external radiation [6 weeks], completion of internal radiation [8 weeks]and 3 months after completion of treatment [20 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival 2. Progression Free survival 3. Radiation treatment breaks 4. ToxicityTimepoint: 1. Overall survival at 2 years 2. Progression Free survival at 2 years 3. Radiation treatment breaks - during 8 weeks of radiation therapy 4. Toxicity - acute toxicities during treatment and late toxicities upto 2 years | — |
Countries
India
Contacts
Public ContactDrRam Madhavan MD
Cancer Institute [WIA] Adyar
Outcome results
None listed