Clinical trial NCT01398449: Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: thoracic esophageal squamous cell carcinoma
esophagectomy
elective nodal irradiation
adjuvant chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Soochow University
name: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
name: Jiangsu Cancer Institute & Hospital
name: Affiliated Hospital of Jiangsu University
name: Zhejiang Cancer Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Zhejiang University
name: The First Affiliated Hospital of Anhui Medical University
name: Anhui Provincial Hospital
name: Fujian Cancer Hospital
name: Shanghai Chest Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
name: RenJi Hospital
First posted: 2011-07-20
Enrollment: 874
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Locoregional control rate
measure: Safety and Tolerability (incidence rate of adverse events)
measure: Failure pattern
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
References: