Overview

This trial is active, not recruiting.

Condition esophageal cancer
Treatment nimotuzumab
Phase phase 2
Target EGFR
Sponsor Chinese Academy of Medical Sciences
Start date October 2011
End date August 2014
Trial size 30 participants
Trial identifier NCT01463605, 11-49/484

Summary

For patients who are unable to receive surgery or having local advanced esophageal cancer stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy for older patients because of their chemoradiotherapy intolerance. The whole world focused on targeted therapy which has strong specialties and mild toxicities. So combined targeted therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer. Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal cancer. All patients receive intensity modulated radiotherapy with conventional fraction. Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
It is just a single group assignment
nimotuzumab
Nimotuzumab 200mg,once per week,for 5 to 6 weeks

Primary Outcomes

Measure
Safety of Nimotuzumab combined with Radiotherapy for older patients
time frame: 2 years

Secondary Outcomes

Measure
Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients
time frame: 3 years

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria: 1. ≥ 70 year-old 2. Thoracic segment esophageal cancer with stage II to IV (supraclavicular lymph node metastasis only) 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed 4. Estimated survival time ≥ 3 months 5. KPS > 60 6. No serious diseases of important organs 7. Signed consent forms voluntarily Exclusion Criteria: 1. Psychopath 2. History of other malignant disease which has not been cured 3. Joining other clinical trial prior this study.

Additional Information

Official title Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial
Principal investigator Liang Jun, Doctor
Description Study Design Primary Purpose: To evaluate the response rate, progression-free survival, overall survival and complications. Study Phase: Phase II Intervention Model: Targeted therapy combined with radiotherapy Number of Arms: One Masking: No Allocation: 30 patients for one single group Enrollment: 30 patients Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Thoracic segment esophageal cancer with stage II to IV (supraclavicular lymph node metastasis only), 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS > 60, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily. Exclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Joining other clinical trial prior this study.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Chinese Academy of Medical Sciences.