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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Liang Jun, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01463605
First received: October 30, 2011
Last updated: November 1, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Esophageal Cancer
 Drug: Nimotuzumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Safety of Nimotuzumab combined with Radiotherapy for older patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To observe the adverse events during the treatment


Secondary Outcome Measures:
  • Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To observe the response rate, progress-free survival and overall survival


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
radiotherapy
It is just a single group assignment
 Drug: Nimotuzumab
Nimotuzumab 200mg,once per week,for 5 to 6 weeks

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463605

Locations
China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Liang Jun, Doctor Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
  More Information

Additional Information:
This review discuss pre-clinical data and the rationale for targeting these pathways and summarize the results of clinical trials to-date.  This link exits the ClinicalTrials.gov site
Changing healthcare practice of older adults with late-stage non-small cell lung cancer: practical considerations of targeted therapy in primary care and oncology.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Liang Jun, Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01463605     History of Changes
Other Study ID Numbers: 11-49/484
Study First Received: October 30, 2011
Last Updated: November 1, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
radiotherapy
targeted therapy
esophageal cancer
older

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on June 13, 2013