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Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer

NCT01216527 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2017-02-27

No results posted yet for this study

Summary

The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery versus surgery, in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.

Conditions

  • Squamous Cell Esophageal Carcinoma

Interventions

PROCEDURE

Neo-adjuvant Chemoradiotherapy followed by Surgery

1. Radiotherapy combined with concomitant chemotherapy: Radiotherapy Program:External radiation with a total dose of 40.0Gy is given in 20 fractions of 2.0Gy,5 fractions a week. neo-chemotherapy program: Vinorelbine 25mg/m2, IV (in the vein) on day 1 and day 8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle;or Cisplatin 25mg/m2,IV DRIP on day 1 to day 4 of each 21 day cycle. Number of cycles:two 2. surgery:Mckeown Modification Surgery and total two-field lymphadenectomy

PROCEDURE

surgery

two field lymphadenectomy

Sponsors & Collaborators

  • Affiliated Cancer Hospital of Shantou University Medical College

    collaborator OTHER

  • Shanghai Chest Hospital

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Taizhou Hospital

    collaborator OTHER

  • The Second People's Hospital of Sichuan

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jian-hua Fu, Professor · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2019-12-31
Completion
2019-12-31

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 NCT01216527 on ClinicalTrials.gov