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

October 30, 2011
November 1, 2011
October 2011
August 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01463605 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
Drug: Nimotuzumab
Nimotuzumab 200mg,once per week,for 5 to 6 weeks
radiotherapy
It is just a single group assignment
Intervention: Drug: Nimotuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
October 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01463605
11-49/484
Yes
Liang Jun, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: Liang Jun, Doctor Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP