A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer
A Randomized Phase II Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Locoregionally Advanced Thoracic Esophageal Squamous Cell Carcinoma
1 other identifier
interventional
300
1 country
1
Brief Summary
A randomized phase II trial to estimate the optimal radiation volume of postsurgical radiation for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma (T3-4, any N, M0).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 8, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedJuly 22, 2011
March 1, 2011
2.7 years
July 8, 2011
July 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
To evaluate if the survival outcome of postsurgical radiation with a small target volume involved tumor bed only is not worse than a large volume (tumor bed and elective nodes) for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma.
Secondary Outcomes (2)
Safety and Tolerability
Failure pattern
Study Arms (2)
A
EXPERIMENTALAfter esophagectomy, patients in Arm A will receive Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy
B
ACTIVE COMPARATORAfter esophagectomy, patients in Arm B will receive small field radiation (tumor bed only) + Sequential chemotherapy
Interventions
In Arm A, postsurgical radiation target volume includes tumor bed and elective nodes area
In Arm B, postsurgical radiation target volume includes tumor bed only
Eligibility Criteria
You may qualify if:
- Age ≥ 18 and ≤70
- 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
- Pathological stage of T3-4N0-3M0
- 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
- +1 more criteria
You may not qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- The First Affiliated Hospital of Soochow Universitycollaborator
- The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, Chinacollaborator
- Jiangsu Cancer Institute & Hospitalcollaborator
- Affiliated Hospital of Jiangsu Universitycollaborator
- Zhejiang Cancer Hospitalcollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- Zhejiang Universitycollaborator
- The First Affiliated Hospital of Anhui Medical Universitycollaborator
- Anhui Provincial Hospitalcollaborator
- Fujian Cancer Hospitalcollaborator
- Shanghai Chest Hospitalcollaborator
- Shanghai Pulmonary Hospital, Shanghai, Chinacollaborator
- RenJi Hospitalcollaborator
Study Sites (1)
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiao-Long Fu, M.D, Ph.D.
Fudan University
Central Study Contacts
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 8, 2011
First Posted
July 12, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2013
Last Updated
July 22, 2011
Record last verified: 2011-03