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

July 25, 2011
July 25, 2011
December 2010
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Squamous Cell Carcinoma
  • Biological: Nimotuzumab
  • Radiation: Radiation therapy
  • Radiation: radiation therapy
  • Drug: chemotherapy
  • Experimental: A
    Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
    Interventions:
    • Biological: Nimotuzumab
    • Radiation: Radiation therapy
    • Drug: chemotherapy
  • Active Comparator: B
    Patients randomized in Arm B will receive chemoradiation only
    Interventions:
    • Radiation: radiation therapy
    • Drug: chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
December 2015
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Xu-Wei Cai, M.D., Ph.D. 8621-64175590 ext 1504 birdhome2000@hotmail.com
China
 
NCT01402180
2010ESO_FU
Yes
Xiao-Long Fu / Professor, Fudan University Cancer Center
Fudan University
  • Shanghai Chest Hospital
  • Shanghai Pulmonary Hospital, Shanghai, China
  • RenJi Hospital
  • Shanghai First People's Hospital
Principal Investigator: Xiao-Long Fu, M.D, Ph.D. Fudan University
Fudan University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP