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

Sponsor
Sun Yat-sen University
Study ID
NCT02465736
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    25mg/ m2 Docetaxel dose administered on days 1, 8, 15, and 22.
  • Cisplatin — DRUG
    25mg/ m2 on days 1, 8, 15 and 22.
  • Radiation — RADIATION
    Patient will receive 4 weeks of radiation therapy (44 Gy/20 fractions).
  • Surgery — PROCEDURE
    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.
  • Vinorelbine — DRUG
    25mg/ m2 on days 1, 8 of each cycle (i.e. every 21 days).
  • Cisplatin — DRUG
    75mg/ m2 on day 1 of each cycle only (i.e. every 21 days).

Study Details

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.

Key Dates

Start date
Jul 31, 2015
Status verified
Jan 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
610 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A (DP-RT)
    • Arm A consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy and 4 weekly cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions: * Radiation: (44 Gy/20 fractions) * Drug: Docetaxel * Drug: Cisplatin
  • Experimental: B (NP-RT)
    • Arm B consists of the concurrent chemoradiotherapy followed by surgery. The patient will receive 4 weeks of radiation therapy and 2 cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Each cycle of chemotherapy lasts 21 days/3 weeks. The drugs include Vinorelbine and Cisplatin. Interventions: * Radiation: (44 Gy/20 fractions) * Drug: Vinorelbine * Drug: Cisplatin

Primary Outcome Measure

Overall survival [ Time Frame: At end of trial- up to 3 years in follow up ]

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