Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma

Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study ID
NCT01752205
Phase
PHASE3
Status
Unknown

Conditions

  • Esophageal Squamous Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    45mg/m2/w,total 6 weeks
  • Erlotinib — DRUG
    150mg/d,days 1-42,total 6 weeks
  • Radiation therapy — RADIATION

Study Details

The purpose of this study is to test the safety and effectiveness of erlotinib and chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous cancer .

Key Dates

First listed
Dec 19, 2012
Start date
Nov 30, 2012
Status verified
Dec 2012
Primary completion
May 31, 2014
Completion
Nov 30, 2014

Study Design

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

Arms

  • Active Comparator: Chemoradiotherapy
    The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w.
  • Experimental: Erlotinib and chemoradiotherapy
    The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.

Primary Outcome Measure

Progression free survival [ Time Frame: 2 year ]

Central Contacts