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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463605
• Other study ID #: 11-49/484
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

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

External Links

•   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 review discuss pre-clinical data and the rationale for targeting these pathways and summarize the results of clinical trials to-date.