CTRI/2018/05/013773CompletedPhase 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 enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
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,
- •g. Serum calcium above the ULRR.
- •6. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease, TB, DM).
- •7. Any history suggestive of presence or previously treated malignancy .
- •8. Presence of tracheo-oesophageal fistula.
- •9. Distant metastasis.
Investigators
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