Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Capecitabine: The drug is started along with radiation therapy instead of after completion of radiation therapy.
Capecitabine [Oral] 1000mg/m2 twice daily form day 1 to day 14
every 21 days..
The first cycle will start from the first day of the radiation therapy.
Sponsors
CHRISTIAN MEDICAL COLLEGE VELLORE
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women with age more than 18 years with histologically confirmed diagnosis of invasive breast cancer of stage I-III invasive mammary carcinoma irrespective of any hormone receptor status with incomplete pathological response after neoadjuvant chemotherapy. 2. Receiving radiotherapy to whole breast or chest wall â?? (treatment of regional nodes permitted) within 6 weeks of surgery date. 3. Completed full course of planned neoadjuvant chemotherapy or at least 4 cycles of neoadjuvant chemotherapy and surgery. 4. Performance score of ECOG 1 or 2. 5. The patient has personally given written, informed consent to participate in this study, and she fully understands that consent can be withdrawn at any time without suffering any disadvantages. 6. Not pregnant 7. Willing for contraception during the treatment duration. 8. No clinically significant cardiac disease. 9. No pre-existing skin diseases within the planned radiotherapy field at the time of study. 10. The patient has maintained sufficient organ function to permit valid evaluation, with respect to physiology, of the safety of capecitabine and hormone therapy (LHRH agonists, anti-estrogen agents, and aromatase- inhibitors), as shown by meeting the following criteria, and she must not have been administered a blood transfusion and/or hematopoietic factors within 2 weeks before the tests for these criteria: a. Leukocyte count: 3,000 to 12,000 /mm3 b. Absolute neutrophil count: >= 1,500 /mm3 c. Platelet count: >= 100,000 /mm3 d. Haemoglobin concentration: >= 9.0g/dL e. AST (SGOT), ALT (SGPT): institutionâ??s criteria (upper limit of normal) f. Alkaline phosphatase: g. Total bilirubin: h. Serum creatinine: i. Electrocardiography: Normal electrocardiographic parameters j. Baseline Echocardiogram: Within normal limits. (At least done within the last 4 months prior to treatment initiation)
Exclusion criteria
Exclusion criteria: 1. Patients not consenting for the study 2. Hypersensitivity to skin film 3. Inflammatory carcinoma of the breast or Pure Ductal Carcinoma in situ 4. Bilateral breast carcinoma -either simultaneous or non-simultaneous bilateral breast cancer 5. Metastatic breast cancer or History of other malignancies or synchronic multiple cancers. 6. Considered to require postoperative chemotherapy other than capecitabine. 7. Previously been treated with oral 5-FU agents (however, previous treatment with IV 5-FU is acceptable). 8. Pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding. 9. Previously had an organ transplant. 10. Hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents, regardless of the presence or absence of dihydropyrimidine dehydrogenase. 11. Currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or haemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months. 12. On treatment for epilepsy and/or central nervous system disorders. 13. If difficulty in administering orally drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract 14. For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and time to onset of grade III and IV radiation dermatitis as assessed by the NCI CTCAE criteria v4.0Timepoint: 1,2,3,4 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of other acute toxicities as assessed by the NCI CTCAE criteria v4.0.Timepoint: 1,2,3,4 and 8 weeks;Overall survival(OS) and Disease-free survival(DFS) at end of 1 and 3 years.Timepoint: 1 and 3 year;Quality of Life as measured by EORTC QLQ C30, EORTC QLQ-BR23 and FACT B.Timepoint: 0,1,2,3,4 and 8 weeks.;Skin toxicity as measured by RISRAS â?? Radiation Induced Skin Reactions Assessment score.Timepoint: 1,2,3,4 and 8 weeks | — |
Countries
India
Contacts
Public ContactTarun Jose
CHRISTIAN MEDICAL COLLEGE, VELLORE
Outcome results
None listed