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Clinical Trials/CTRI/2018/05/013773
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
IPGMER Fluid Research Fund

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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