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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01402180

Acronym

Nimotuzumab

Enrollment

128

Registered

2011-07-26

Start date

2010-12-31

Completion date

2015-12-31

Last updated

2011-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal squamous cell carcinoma, lymph nodes recurrence, chemoradiation, Nimotuzumab

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.

Interventions

BIOLOGICALNimotuzumab

RADIATIONRadiation therapy

RADIATIONradiation therapy

DRUGchemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Adverse Events	—	—

Countries

China

Contacts

Primary ContactXu-Wei Cai, M.D., Ph.D.

birdhome2000@hotmail.com8621-64175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026