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Study of Docetaxel or Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Esophageal Cancer (NEOCRTEC308)

NCT02465736 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2024-01-16

No results posted yet for this study

Summary

The primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma.

Conditions

Interventions

DRUG

Docetaxel

25mg/ m2 Docetaxel dose administered on days 1, 8, 15, and 22.

DRUG

Cisplatin

25mg/ m2 on days 1, 8, 15 and 22.

RADIATION

Radiation

Patient will receive 4 weeks of radiation therapy (44 Gy/20 fractions).

PROCEDURE

Surgery

McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 4-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.

DRUG

Vinorelbine

25mg/ m2 on days 1, 8 of each cycle (i.e. every 21 days).

DRUG

Cisplatin

75mg/ m2 on day 1 of each cycle only (i.e. every 21 days).

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hong Yang, Ph.D., M.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT02465736 on ClinicalTrials.gov