eoadjuvant Short course radiotherapy in esophageal carcinoma
- Conditions
- Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified
- Registration Number
- CTRI/2020/12/029851
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological Complete Response (pCR) rates in the resected specimenTimepoint: post surgery (week 9 - 11)
- Secondary Outcome Measures
Name Time Method Assess quality of lifeTimepoint: Baseline, post neoadjuvant chemoRT, 3 months post treatment;R0 (Complete resection) ratesTimepoint: Postoperatively;To estimate 30-day perioperative morbidityTimepoint: 30 day perioperative morbidity;To estimate 30-day perioperative mortalityTimepoint: 30-day perioperative mortality;To estimate the acute toxicities related to the regimenTimepoint: During treatment