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 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

•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.

发起方

IPGMER Fluid Research Fund