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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


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Esophageal Squamous Cell Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local control

Outcome Description:

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.

Safety Issue:

No

Principal Investigator

Xiao-Long Fu, M.D, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

People's Republic of China: State Food and Drug Administration

Study ID:

2010ESO_FU

NCT ID:

NCT01402180

Start Date:

December 2010

Completion Date:

December 2015

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • Esophageal squamous cell carcinoma
  • lymph nodes recurrence
  • chemoradiation
  • Nimotuzumab
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Recurrence

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