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Perioperative Vs. Preoperative Chemotherapy With Surgery in the Squamous Carcinoma of Esophagus

NCT01225523 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2010-10-21

No results posted yet for this study

Summary

To assess whether or not a perioperative therapy with surgery can improve the outcomes among patients with potentially curable squamous carcinoma of esophagus as compared to a preoperative chemotherapy followed by surgery

Conditions

  • Squamous Carcinoma of Esophagus
  • Esophagus Disorders

Interventions

DRUG

Paclitaxel; Cisplatin; 5-Fluorouracil

Two preoperative cycles with Paclitaxel 200 mg/m² d1, Cisplatin 60 mg/m² d1, 5-Fluorouracil 700 mg/m² d1-5 repeated every 3 weeks followed by resection

DRUG

Paclitaxel; Cisplatin; 5-Fluorouracil; Capecitabine

Two postoperative cycles with Paclitaxel 200 mg/m²/day d1, Cisplatin 60 mg/m²/day d1, 5-Fluorouracil 700 mg/m²/day d1-5 repeated every 3 weeks Among patients with no responses to preoperative chemotherapy, Capecitabine 625 mg/m² twice-daily dose as alternatives to infused 5-Fluorouracil in the postoperative chemotherapy regimen

Sponsors & Collaborators

  • Xi'an Jiaotong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1997-01-31
Primary Completion
2008-12-31
Completion
2010-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225523 on ClinicalTrials.gov