Status:
UNKNOWN
Phase II/III Study Compare Adjuvant Chemoradiotherapy, Radiotherapy and Surgery Alone for Esophageal Carcinoma
Lead Sponsor:
Zefen Xiao
Conditions:
Esophageal Neoplasms
Esophageal Cancer
Eligibility:
All Genders
18-68 years
Phase:
PHASE2
PHASE3
Brief Summary
This phase III trial is studying how well the combination of chemoradiation or radiation works in resected locally advanced cancer of the esophagus or gastroesophageal junction.
Detailed Description
Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, considerable number of esophageal cancer patients received ...
Eligibility Criteria
Inclusion
- KPS≥70
- Diagnosis of stage ⅡB or Ⅲ thoracic esophageal cancer
- Complete resection
- Adequate organ function:
- Hematopoietic Absolute granulocyte count at least 1,500/mm\^3 Platelet count at least 150,000/mm\^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension
Exclusion
- Uncontrolled diabetes
- Interval between surgery and adjuvant therapy more than 3 months
- Sign of recurrence on CT scan or ultrasound or PET-CT No palpable subclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan
- With Weight loss greater than 10% from baseline
- With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- Be pregnant
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02279134
Start Date
October 1 2014
End Date
December 1 2024
Last Update
April 3 2020
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021