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

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: radiation therapy; Biological: Nimotuzumab; Drug: chemotherapy

• Registration Number: NCT01402180
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2010-11
• Study Start: 2010-12
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Last Update Submitted: 2011-07-25
• Study First Posted: 2011-07-26
• Last Update Posted: 2011-07-26
• Primary Completion: 2013-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	radiation therapy	Patients randomized in Arm B will receive chemoradiation only
A	radiation therapy	Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
A	Nimotuzumab	Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
A	chemotherapy	Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
B	chemotherapy	Patients randomized in Arm B will receive chemoradiation only

Primary Outcome Measures

Name	Time	Method
Local control		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

Name	Time	Method
Adverse Events
Overall survival		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.

Trial Locations

Locations (1)

Fudan University Cancer Center; 🇨🇳 Shanghai, Shanghai, China