CTRI/2018/05/013773
Completed
Phase 3
A Comparative Study Of Induction Chemotherapy Followed By Radiotherapy Versus Concurrent Chemo Radiotherapy In Locally Advanced Squamous Cell Carcinoma Of Oesophagus : A Randomized Controlled Trial.
IPGMER Fluid Research Fund0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Locally Advanced Squamous Cell Carcinoma Of Oesophagus.
- Sponsor
- IPGMER Fluid Research Fund
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histological proven squamous cell carcinoma of oesophagus.
- •2\. Locally advanced stage, clinically defined as a T3N0 or T3N1 tumour according to the 1997 UICC classification, or stage T2N0 or T2N1,.
- •3\. ECOG performance status 2 or less.
- •4\. Hematologic, hepatic, and renal functions with in normal limit.
Exclusion Criteria
- •1\. Previous radiotherapy, chemotherapy and surgical oesophageal treatment (Except laser therapy).
- •2\. Pregnancy and lactating mother.
- •3\. Known hypersensitivity to the chemotherapy drugs / irradiation under study.
- •4\. Abnormal initial haematology e.g.
- •a. Haemoglobin \< 10 gm%.
- •b. Platelets \< 75000/mm3\.
- •c. Absolute Neutrophil Count (ANC) \< 1000/mm3\.
- •d. Serum bilirubin \> 2 .5 times the upper limit of the reference range (ULRR).
- •e. Alanine amino\-transferase (ALT or SGPT) or Aspartate amino\-transferase(AST or SGOT) \>5 times the ULRR.
- •f. Creatinine \> 2\.0 times the ULRR,
Outcomes
Primary Outcomes
Not specified
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