Esophageal Cancer Clinical Trial
Official title:
Long-term Results of Definitive Concurrent Chemoradiotherapy Using Paclitaxel Plus Oxaliplatin in Unresectable Locally Advanced Esophageal Cancer.
Verified date | February 2016 |
Source | Hangzhou Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.
Status | Completed |
Enrollment | 34 |
Est. completion date | November 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Cytologically or histologically confirmed esophageal carcinoma 2. Age of 20 -80 3. ECOG performance status: 0-1; 4. No treatments prior to enrollment; 5. At least one measurable lesion on CT, MRI or esophageal barium exam; 6. Normal functions of heart, lung, liver, kidney and bone marrow 7. Blood exams qualified for chemotherapy, which included hemoglobulin =9 g/dl, neutrophil =1.5×109/L and platelet (PLT) =100×109/L, creatinine =1.5 UNL 8. Informed consent signed Exclusion Criteria: 1. Prior treatments of chemotherapy or irradiation; 2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable; 3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis; 4. Participating in other clinical trials; 5. Pregnancy, breast feeding, or not adopting birth control; 6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities 7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hangzhou Cancer Hospital |
Zhang P, Xie CY, Wu SX. [Concurrent chemoradiation with paclitaxel and platinum for locally advanced esophageal cancer]. Zhonghua Zhong Liu Za Zhi. 2007 Oct;29(10):773-7. Chinese. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rate | Response rate was done after 4 weeks following the last radiotherapy session. | week 4 | |
Secondary | Survival outcome | Progression-free survival (PFS) was calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining. Overall survival (OS) was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death. | year 0- year 5 | |
Secondary | Toxicity | Acute toxicities and late toxicities based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0). | year 0- year 5 |
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