Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01463605

Collaborator

(none)

Enrollment

Location

Arm

104

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: Nimotuzumab	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial

Actual Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: radiotherapy It is just a single group assignment	Drug: Nimotuzumab Nimotuzumab 200mg,once per week,for 5 to 6 weeks

Arm

Intervention/Treatment

Other: radiotherapy

It is just a single group assignment

Drug: Nimotuzumab

Nimotuzumab 200mg,once per week,for 5 to 6 weeks

Outcome Measures

Primary Outcome Measures

Safety of Nimotuzumab combined with Radiotherapy for older patients [2 years]
To observe the adverse events during the treatment

Secondary Outcome Measures

Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients [3 years]
To observe the response rate, progress-free survival and overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients aged 70 years or older;
treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT;
stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system;
estimated survival time ≥3 months;
Karnofsky performance score ≥70;
adequate bone marrow, as well as hepatic and renal function;
voluntary written consent provided prior to treatment.