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

Phase 2

Completed

• Conditions: Esophageal Cancer
• Interventions: Drug: Nimotuzumab

• Registration Number: NCT01463605
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-10-30
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-02
• Primary Completion: 2016-12
• Study Completion: 2020-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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

Exclusion Criteria

1. esophagobronchial or esophagomediastinal fistula;
2. patients who had joined other clinical trials prior to this treatment;
3. serious heart, liver, and/or kidney insufficiency;
4. serious infectious disease;
5. relapse disease or distant metastasis;
6. recently diagnosed neoplastic diseases;
7. previous receipt of surgery, chemotherapy, or radiotherapy for EC.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiotherapy	Nimotuzumab	It is just a single group assignment

Primary Outcome Measures

Name	Time	Method
Safety of Nimotuzumab combined with Radiotherapy for older patients	2 years	To observe the adverse events during the treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China