CTRI/2020/12/029851
Not yet recruiting
Phase 2
Phase 2 single arm study to evaluate safety and efficacy of neoadjuvant short course radiotherapy along with chemotherapy followed by surgery in resectable carcinoma of esophagus
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified
- Sponsor
- AIIMS Rishikesh
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Histologically Proven Esophageal or Gastroesophageal junction (Sievert 1 or 2\) Carcinoma patients who are medically fit for surgery
- •2\.Stage II to IVA
- •3\.Age: 18\-70 years
- •4\.ECOG: 0\-2
- •5\.Normal hemodynamic indices before the recruitment (including white blood cell count \>4\.0Ã?109/L, neutrophil count \>1\.5Ã?109/L, platelet count \>100Ã?109/L, hemoglobin\>\=90g/l, normal liver/kidney function)
- •6\.Able to understand this study and have signed informed consent.
Exclusion Criteria
- •1\. Have been previously treated with chemotherapy, radiotherapy and other anti\-tumour treatment except surgery for non GI cancer
- •2\. Known or suspected allergy to paclitaxel or carboplatin;
- •3\. Female in pregnancy or lactating;
- •4\. Patients with significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;
- •5\. Patients with peripheral neuropathy (CTC grade\>\=2\);
- •6\. The patient not tolerant to neoadjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, immune system diseases, nervous system diseases, cachexia, etc.
Outcomes
Primary Outcomes
Not specified
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