Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2010 by Fudan University
Sponsor:
Collaborators:
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
RenJi Hospital
Shanghai First People's Hospital
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01402180
First received: July 25, 2011
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

A randomized phase II tials to study whether it's benefit of adding Nimotuzumab to chemoradiation for patients with esophageal squamous cell carcinoma after radical esophagectomy who suffer with locoregional lymph nodes recurrence.


Condition Intervention Phase
Esophageal Squamous Cell Carcinoma
Biological: Nimotuzumab
Radiation: Radiation therapy
Radiation: radiation therapy
Drug: chemotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial Evaluating The Addition Of Nimotuzumab To Chemoradiation For Patients With Esophageal Squamous Cell Carcinoma After Radical Esophagectomy Who Suffer With Lymph Nodes Recurrence

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Local control [ Designated as safety issue: No ]
    To evaluate if the addition of nimotuzumab to chemoradiation improves local control compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.


Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
    To evaluate if the addition of nimotuzumab to chemoradiation improves overall survival compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.

  • Adverse Events [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
Biological: Nimotuzumab Radiation: Radiation therapy Drug: chemotherapy
Active Comparator: B
Patients randomized in Arm B will receive chemoradiation only
Radiation: radiation therapy Drug: chemotherapy

Detailed Description:

Patient population:

Esophageal squamous cell carcinoma after radical esophagectomy, then recurrent with lymph nodes in bilateral supravascular fossa or upper mediastinum 6 months beyond esophagectomy.

Scheme:

Eligible recurrent patients with esophageal cancer will first be stratified by recurrent time after esophagectomy (within 2 years after esophagectomy, or beyond 2 years after esophagectomy), then randomized to 2 arms at 1:1 ratio.

Arm A:

Chemoradiation + weekly Nimotuzumab for 6 weeks concurrent with radiation.

Arm B:

Chemoradiation only.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and ≤75
  2. ECOG performance status 0-2
  3. Histologically proven primary thoracic esophageal squamous cell carcinoma before
  4. Diagnosis of regional lymph nodes (biosupravascular fossa or upper mediastinum) recurrence after radical esophagectomy, based on pathological finding or imaging showing lymph nodes enlargement
  5. Period from esophagectomy to diagnosis of regional lymph nodes recurrence should be more than 6 months
  6. Without prior radiotherapy
  7. Weight loss no more than 10% in the past 6 months
  8. WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
  9. Platelets ≥ 100X109/L
  10. Hemoglobin ≥ 90g/L(without blood transfusion)
  11. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
  12. Creatinine ≤ 1.5 x upper limit of normal
  13. Sign study-specific informed consent prior to study entry

Exclusion Criteria:

  1. With recurrence or metastasis other than regional lymph nodes (biosupravascular fossa or upper mediastinum)
  2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  3. Severe, active comorbidity, defined as follows:

    3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

  4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
  5. Prior radiation therapy or prior target drug therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402180

Contacts
Contact: Xu-Wei Cai, M.D., Ph.D. 8621-64175590 ext 1504 birdhome2000@hotmail.com

Locations
China, Shanghai
Fudan University Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xu-Wei Cai, M.D., Ph.D.    8621-64175590 ext 1504    birdhome2000@hotmail.com   
Principal Investigator: Xiao-Long Fu, M.D., Ph.D.         
Sponsors and Collaborators
Fudan University
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
RenJi Hospital
Shanghai First People's Hospital
Investigators
Principal Investigator: Xiao-Long Fu, M.D, Ph.D. Fudan University
  More Information

No publications provided

Responsible Party: Xiao-Long Fu / Professor, Fudan University Cancer Center
ClinicalTrials.gov Identifier: NCT01402180     History of Changes
Other Study ID Numbers: 2010ESO_FU
Study First Received: July 25, 2011
Last Updated: July 25, 2011
Health Authority: People's Republic of China: State Food and Drug Administration

Keywords provided by Fudan University:
Esophageal squamous cell carcinoma
lymph nodes recurrence
chemoradiation
Nimotuzumab

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Recurrence
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Disease Attributes
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014