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

Esophageal Squamous Cell Carcinoma Clinical Trial

— Nimotuzumab  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01402180
• Other study ID #: 2010ESO_FU
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 25, 2011
• Last updated: July 25, 2011
• Start date: December 2010
• Est. completion date: December 2015

Study information

• Verified date: November 2010
• Source: Fudan University
• Contact: Xu-Wei Cai, M.D., Ph.D.
• Phone: 8621-64175590
• Email: birdhome2000[@]hotmail.com
• Is FDA regulated: No
• Health authority: People's Republic of China: State Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Recurrence

Intervention

Biological:
• Nimotuzumab

Radiation:
• Radiation therapy

• radiation therapy

Drug:
• chemotherapy

• chemotherapy

Locations

Country	Name	City	State
China	Fudan University Cancer Center	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Fudan University	RenJi Hospital, Shanghai Chest Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	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.		No
Secondary	Adverse Events			Yes