RESPONSE OF CANCER DRUGS BEFORE SURGERY IN ESOPHAGEAL CANCER AND ALSO COMPARING TWO DIFFERENT CANCER DRUGS COMBINATIONS CISPLATIN PLUS 5FU AND PACLITAXEL AND CARBOPLATIN

Efficacy of Neoadjuvant chemotherapy in carcinoma esophagus A pilot study comparing Cisplatin plus 5FU with Paclitaxel plus Carboplatin

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009658

Enrollment

Registered

2017-09-06

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- Carcinoma esophagus

Interventions

Intervention1: ARM-1: PACLITAXEL PLUS CARBOPLATIN Control Intervention1: ARM-2: CISPLATIN PLUS 5FU

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 2. Squamous cell carcinoma of esophagus and gastroesophageal junction 3. Good performance status- ECOG (Eastern cooperative oncology group) 0,1 and 2 4. Imaging suggests potentially operable cases (Up to T4a stage)

Exclusion criteria

Exclusion criteria: 1. Medically inoperable cases like poor performance status ECOG >2 2. Gross tumor infiltration in to the mediastenal structure like- tracheal infiltration, large contact with aorta, atrium involvement 3. Cases with distant Metastasis 4. Carcinoma involving cervical esophagus 5. Patient who have already received radiotherapy or chemotherapy 6. Patient refused for consent for the study

Design outcomes

Primary

Measure	Time frame
1. To assess the radiological response rate to neoadjuvant chemotherapy in carcinoma esophagus by PERCIST (positron emission tomography response criteria in solid tumors) 2. omparison of the response in between two chemotherapy regimens ( Paclitaxel +Carboplatin and Cisplatin+5 FU) Timepoint: 3 CYCLE	—

Secondary

Measure	Time frame
1. Pathological response assessment by Mandard tumor regression grading system,Assessment of chemotherapy induced toxicity as per Common Terminology Criteria for Adverse Events (CTCAE version 4.0),Assessment of Operative morbidities and mortality, Assessment of Progression -free survival (PFS) â??It will be measured from the date of randomization to the date of first evidence of relapse, progression or death due to any cause, whichever will be observed first, Assessment of resectability rateTimepoint: AFTER SURGERY	—

Measure

Time frame

1. Pathological response assessment by Mandard tumor regression grading system,Assessment of chemotherapy induced toxicity as per Common Terminology Criteria for Adverse Events (CTCAE version 4.0),Assessment of Operative morbidities and mortality, Assessment of Progression -free survival (PFS) â??It will be measured from the date of randomization to the date of first evidence of relapse, progression or death due to any cause, whichever will be observed first, Assessment of resectability rateTimepoint: AFTER SURGERY

—

Countries

India

Contacts

Public ContactDr Naveen kumar

AIIMS

DR_SUNILK@HOTMAIL.COM9968300241

Outcome results

None listed

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