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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01463605
Other study ID # 11-49/484
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2011
Est. completion date February 2020

Study information

Verified date February 2021
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date February 2020
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of Nimotuzumab combined with Radiotherapy for older patients To observe the adverse events during the treatment 2 years
Secondary Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients To observe the response rate, progress-free survival and overall survival 3 years
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