Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Squamous Cell Carcinoma |
Radiation: Elective nodal irradiation (ENI) Other: Adjuvant chemotherapy only |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Overall survival [ Designated as safety issue: No ]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
- Locoregional control rate [ Designated as safety issue: No ]
- Safety and Tolerability (incidence rate of adverse events) [ Designated as safety issue: Yes ]the incidence rate of adverse events, especially radiation-induced lung toxicity
- Failure pattern [ Designated as safety issue: No ]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
| Estimated Enrollment: | 874 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: B
After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)
|
Radiation: Elective nodal irradiation (ENI) |
|
Active Comparator: A
After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only
|
Other: Adjuvant chemotherapy only |
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 and ≤70
- ECOG performance status 0-1
- Weight is not less than 90% of it before operation
- Registration within 8 weeks after esophagectomy
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- R0 resection and number of lymph nodes dissected ≥15 after esophagectomy
- Stage T1-2N1-3M0 based pathological diagnosis
- Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)
- Without supraclavicular nodes and abdominal regions nodes existed after surgery
- Without neo-adjuvant chemotherapy and radiotherapy
- 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
Exclusion Criteria:
- Multiple primary esophageal tumors
- 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:
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.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
- Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy
Contacts and Locations| Contact: Xu-Wei Cai, M.D., Ph.D. | 8621-64175590 ext 1504 | birdhome2000@hotmail.com |
| China, Shanghai | |
| Fudan University Cancer Center | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Xu-Wei Cai, M.D., Ph.D. 8621-64175590 ext 1504 birdhome2000@hotmail.com | |
| Principal Investigator: Xiao-Long Fu, M.D., Ph.D. | |
More Information
No publications provided
| Responsible Party: | Xiao-Long Fu / Professor, Fudan University Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01398449 History of Changes |
| Other Study ID Numbers: | 2011ESO_FU_02 |
| Study First Received: | July 13, 2011 |
| Last Updated: | July 19, 2011 |
| Health Authority: | People's Republic of China: State Food and Drug Administration |
Keywords provided by Fudan University:
|
thoracic esophageal squamous cell carcinoma esophagectomy elective nodal irradiation adjuvant chemotherapy |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Gastrointestinal Diseases Digestive System Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013