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 Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Nimotuzumab

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: radiotherapy; It is just a single group assignment	Drug: Nimotuzumab; Nimotuzumab 200mg,once per week,for 5 to 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Nimotuzumab combined with Radiotherapy for older patients	To observe the adverse events during the treatment	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients	To observe the response rate, progress-free survival and overall survival	3 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Liang Jun, Doctor, Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: October 30, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (Estimate): November 2, 2011

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: radiotherapy; esophageal cancer; targeted therapy; older
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: 11-49/484