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Comparative study of chemotherapy in esophagus carcinoma.

Comparative study for efficacy and safety of Paclitaxel with Platinum analogue versus 5-Fluorouracil with Platinum analogue in resectable carcinoma esophagus

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004516
Enrollment
350
Registered
2014-04-02
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- All patients of Ca Esophagus or GE Junction planned for NACT in thoracic joint clinic will be included if they are fit to receive platinum based chemotherapy

Interventions

Intervention1: 5-Fluorouracil with Platinum: 5 FU 1000mg/m2 day 1- day 4 with cisplatin 75 mg/m2 day 1 OR carboplatin AUC 6 every 3 weeks for 3 cycles. Since both these regimens are established standa

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Histologic confirmation of pathology: Squamous cell or adenocarcinoma of ca esophagus or GE junction. 2. Age 18 years or older 3. Eastern Cooperative Oncology Group performance status of 0 to 2 4. Adequate bone marrow, hepatic, renal, and pulmonary function 5. Willingness to provide written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria shall be: 1. Prior therapy for carcinoma esophagus or GE junction 2. Evidence of distant metastases 3. Received any of the investigational product in the last 30 days 4. Patients who were pregnant or lactating 5. Patients with uncontrolled or severe cardiovascular disease 6. Pre-existing neurotoxicity greater than National Cancer Instituteâ??Common Toxicity Criteria (NCI-CTC) grade 2

Design outcomes

Primary

MeasureTime frame
Primary- Efficacy of these two regimens (TRG Post Chemotherapy) Timepoint: 3 years

Secondary

MeasureTime frame
Secondary - Safety of these two regimens QOL in these two regimens Hospital admission required after chemotherapy administration R0 resection rate Progression free survival Overall Survival Timepoint: 3 years

Countries

India

Contacts

Public ContactDr Vibhor Sharma

Tata Memorial Hospital

vibhor81@yahoo.co.in07738519711

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026