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.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013773

Enrollment

Registered

2018-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Locally Advanced Squamous Cell Carcinoma Of Oesophagus.

Interventions

Intervention1: Arm B â?? Concurrent Chemo Radiotherapy in the management of locally advanced squamous cell carcinoma of oesophagus.: Arm B- will be given Concurrent Chemo Radiotherapy consisti

Eligibility

Inclusion 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

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 b. Platelets c. Absolute Neutrophil Count (ANC) 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.

Design outcomes

Primary

Measure	Time frame
To assess the treatment response using RECIST (Response Evaluation Criteria In Solid Tumour) criteria in terms of complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD).Timepoint: After 6-8 weeks of completion of treatment in both arm.	—

Secondary

Measure	Time frame
1. To determine acute and chronic toxicity according to RTOG / EORTC Acute and Chronic radiation morbidity Criteria. 2. To assess overall survival and disease free survival at 1 year (for complete responders) and progression free survival (for Partial Responder & Stable Disease) at 1 year in both arm. 3. To assess subjective response in terms of palliation of dysphagia. Timepoint: All the cases during and after treatment will be followed up clinically every week. Patient will be assessed at 4-6 weeks after completion of treatment and thereafter every month for first 3 months after completion of treatment and thereafter at an interval of 3 months till the end of the study.	—

Measure

Time frame

1. To determine acute and chronic toxicity according to RTOG / EORTC Acute and Chronic radiation morbidity Criteria. 2. To assess overall survival and disease free survival at 1 year (for complete responders) and progression free survival (for Partial Responder & Stable Disease) at 1 year in both arm. 3. To assess subjective response in terms of palliation of dysphagia. Timepoint: All the cases during and after treatment will be followed up clinically every week. Patient will be assessed at 4-6 weeks after completion of treatment and thereafter every month for first 3 months after completion of treatment and thereafter at an interval of 3 months till the end of the study.

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Countries

India

Contacts

Public ContactDR SILADITYA ROY CHOWDHURY

Institute of Post Graduate Medical Education And Research,S.S.K.M. Hospital.

alokeghoshdastidar@yahoo.com9831118494

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026