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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring radiotherapy, targeted therapy, esophageal cancer, older

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

radiotherapy

Arm Description

It is just a single group assignment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2011
Last Updated
February 2, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01463605
Brief Title
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
Official Title
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
radiotherapy, targeted therapy, esophageal cancer, older

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiotherapy
Arm Type
Other
Arm Description
It is just a single group assignment
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
Nimotuzumab 200mg,once per week,for 5 to 6 weeks
Primary Outcome Measure Information:
Title
Safety of Nimotuzumab combined with Radiotherapy for older patients
Description
To observe the adverse events during the treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients
Description
To observe the response rate, progress-free survival and overall survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: esophagobronchial or esophagomediastinal fistula; patients who had joined other clinical trials prior to this treatment; serious heart, liver, and/or kidney insufficiency; serious infectious disease; relapse disease or distant metastasis; recently diagnosed neoplastic diseases; previous receipt of surgery, chemotherapy, or radiotherapy for EC.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Jun, Doctor
Organizational Affiliation
Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.elsevierhealth.com/journals/ctrv
Description
This review discuss pre-clinical data and the rationale for targeting these pathways and summarize the results of clinical trials to-date.
URL
http://www.ncbi.nlm.nih.gov/sites/entrez
Description
Changing healthcare practice of older adults with late-stage non-small cell lung cancer: practical considerations of targeted therapy in primary care and oncology.

Learn more about this trial

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

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