Clinical trial NCT01402180: Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Esophageal squamous cell carcinoma
lymph nodes recurrence
chemoradiation
Nimotuzumab
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Chest Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
name: RenJi Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2011-07-26
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Local control
Secondary outcomes:
measure: Overall survival
measure: Adverse Events
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xiao-Long Fu, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: