Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Is Elective Nodal Irradiation (ENI) Necessary For Patients With Thoracic Esophageal Squamous Cell Carcinoma Who Undergo Esophagectomy And With Pathological Stage Of T1-2,N+,M0 -- A Randomized Phase Ⅲ Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01398449
• Other study ID #: 2011ESO_FU_02
• Status: Recruiting
• Phase: Phase 3
• First received: July 13, 2011
• Last updated: July 19, 2011
• Start date: April 2011
• Est. completion date: December 2017

Study information

• Verified date: March 2011
• 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

Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?

Description:

Patient Population:

Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging.

R0 resection; T1-2, N+, M0.

Scheme:

After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (<3 or >=3). Then patients are randomized to 2 arms:

Arm A:

Adjuvant chemotherapy (4 cycles).

Arm B:

Adjuvant chemotherapy (4 cycles) + Elective Nodal Irradiation (bilateral supraclavicular fossa and mediastinum).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 874
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age = 18 and =70

2. ECOG performance status 0-1

3. Weight is not less than 90% of it before operation

4. Registration within 8 weeks after esophagectomy

5. Histologically proven primary thoracic esophageal squamous cell carcinoma

6. R0 resection and number of lymph nodes dissected =15 after esophagectomy

7. Stage T1-2N1-3M0 based pathological diagnosis

8. Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)

9. Without supraclavicular nodes and abdominal regions nodes existed after surgery

10. Without neo-adjuvant chemotherapy and radiotherapy

11. WBC= 4.0X109/L ,Absolute neutrophil count (ANC) = 2.0X109/L

12. Platelets = 100X109/L

13. Hemoglobin = 90g/L(without blood transfusion)

14. AST (SGOT)/ALT (SGPT) = 2.5 x upper limit of normal, Bilirubin = 1.5 x upper limit of normal

15. Creatinine = 1.5 x upper limit of normal

16. Sign study-specific informed consent prior to study entry

Exclusion Criteria:

1. Multiple primary esophageal tumors

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 systemic chemotherapy, 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

Intervention

Radiation:
• Elective nodal irradiation (ENI)

Other:
• Adjuvant chemotherapy only

Locations

Country	Name	City	State
China	Fudan University Cancer Center	Shanghai	Shanghai

Sponsors (14)

Lead Sponsor

Collaborator

Fudan University

Affiliated Hospital of Jiangsu University, Anhui Provincial Hospital, First Affiliated Hospital of Wenzhou Medical University, Fujian Cancer Hospital, Jiangsu Cancer Institute & Hospital, RenJi Hospital, Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Soochow University, Zhejiang Cancer Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0		No
Secondary	Locoregional control rate			No
Secondary	Safety and Tolerability (incidence rate of adverse events)	the incidence rate of adverse events, especially radiation-induced lung toxicity		Yes
Secondary	Failure pattern	To evaluate the rationality of ENI after esophagectomy by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences		No