Clinical trial NCT01463605: Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
Official title: Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: radiotherapy
targeted therapy
esophageal cancer
older
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2011-11-02
Enrollment: 46
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety of Nimotuzumab combined with Radiotherapy for older patients
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
name: Liang Jun, Doctor
role: PRINCIPAL_INVESTIGATOR
References: