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

NCT ID: NCT01463605

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2020-02-29

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiotherapy

It is just a single group assignment

Group Type: OTHER

Nimotuzumab

Intervention Type: DRUG

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

Interventions

Nimotuzumab

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Liang Jun

Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang Jun, Doctor

Role: PRINCIPAL_INVESTIGATOR

Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Related Links

http://www.elsevierhealth.com/journals/ctrv

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

http://www.ncbi.nlm.nih.gov/sites/entrez

Changing healthcare practice of older adults with late-stage non-small cell lung cancer: practical considerations of targeted therapy in primary care and oncology.

Other Identifiers

11-49/484

Identifier Type: -

Identifier Source: org_study_id