Comparative Study of Treatment Outcome in the Patients suffering from Locally Advanced Esophageal Cancers without any distant metastasis, treated with either Chemotherapy followed by Radiotherapy or Chemotherapy and Radiotherapy Simultaneously.
- Conditions
- Health Condition 1: null- Locally Advanced Squamous Cell Carcinoma Of Oesophagus.
- Registration Number
- CTRI/2018/05/013773
- Lead Sponsor
- IPGMER Fluid Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method