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

NCT01463605 | Completed Phase 2 DMC

• 1 other identifier: 11-49/484
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

radiotherapy; targeted therapy; esophageal cancer; older

Outcome Measures

Primary Outcomes (1)

• Safety of Nimotuzumab combined with Radiotherapy for older patients

  To observe the adverse events during the treatment

  2 years

Secondary Outcomes (1)

• Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients

  3 years

Study Arms (1)

radiotherapy

OTHER

It is just a single group assignment

Drug: Nimotuzumab

Interventions

Nimotuzumab DRUG

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

radiotherapy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients aged 70 years or older;
• treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT;
• stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system;
• estimated survival time ≥3 months;
• Karnofsky performance score ≥70;
• adequate bone marrow, as well as hepatic and renal function;
• voluntary written consent provided prior to treatment.

You may not qualify if:

• esophagobronchial or esophagomediastinal fistula;
• patients who had joined other clinical trials prior to this treatment;
• serious heart, liver, and/or kidney insufficiency;
• serious infectious disease;
• relapse disease or distant metastasis;
• recently diagnosed neoplastic diseases;
• previous receipt of surgery, chemotherapy, or radiotherapy for EC.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Related 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.

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Liang Jun, Doctor

  Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

Study Record Dates

• First Submitted: October 30, 2011
• First Posted: November 2, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

CN (1)