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

NCT01402180 | Unknown Phase 2 DMC

• 1 other identifier: 2010ESO_FU
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival

• Adverse Events

Study Arms (2)

A

EXPERIMENTAL

Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation

Biological: Nimotuzumab; Radiation: Radiation therapy; Drug: chemotherapy

B

ACTIVE COMPARATOR

Patients randomized in Arm B will receive chemoradiation only

Radiation: radiation therapy; Drug: chemotherapy

Interventions

Nimotuzumab BIOLOGICAL

A

radiation therapy RADIATION

A

chemotherapy DRUG

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤75
• ECOG performance status 0-2
• Histologically proven primary thoracic esophageal squamous cell carcinoma before
• Diagnosis of regional lymph nodes (biosupravascular fossa or upper mediastinum) recurrence after radical esophagectomy, based on pathological finding or imaging showing lymph nodes enlargement
• Period from esophagectomy to diagnosis of regional lymph nodes recurrence should be more than 6 months
• Without prior radiotherapy
• Weight loss no more than 10% in the past 6 months
• WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
• Platelets ≥ 100X109/L
• Hemoglobin ≥ 90g/L(without blood transfusion)
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
• Creatinine ≤ 1.5 x upper limit of normal
• Sign study-specific informed consent prior to study entry

You may not qualify if:

• With recurrence or metastasis other than regional lymph nodes (biosupravascular fossa or upper mediastinum)
• 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).
• Severe, active comorbidity, defined as follows:
• 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.
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
• Prior radiation therapy or prior target drug therapy

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Chest Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• RenJi Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

nimotuzumab; Radiotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xiao-Long Fu, M.D, Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu-Wei Cai, M.D., Ph.D.

CONTACT

8621-64175590; birdhome2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: July 26, 2011

Record last verified: 2010-11

Locations

CN (1)