Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Verified date | October 2018 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.
Status | Completed |
Enrollment | 436 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Joined the study voluntarily and signed informed consent form; - Age 18-75 - Both genders - Esophageal squamous cell carcinoma confirmed by pathology - Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002) - No radiotherapy, chemotherapy or other treatments prior to enrollment - PS ECOG 0-2 - Life expectancy of more than 3 months - Hemoglobin(Hb)=9 g/dL - WBC=3x109/L, Neutrophils (ANC )=1.5x109/L - platelet count (Pt) =100x 109/L - Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN - Renal function: creatinine < 1.5 x ULN - No immuno-deficiency - Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: - Complete esophageal obstruction - Deep esophageal ulcer - Esophageal perforation - Haematemesis - After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy - Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years - Participation in other interventional clinical trials within 30 days - Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives - Drug addiction - Alcoholism or AIDS - Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior - Patient who has metastasis such as lung, liver metastasis |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Cancer Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University | Affiliated Hospital of Jiangnan University, First Affiliated Hospital of Zhejiang University, Fudan University Shanghai Cancer Center Minhang Branch, Fujian Cancer Hospital, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital of Xiamen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-yr overall survival | 3 years | ||
Secondary | Disease progression-free survival | 3 years | ||
Secondary | Local progression-free survival | 3 years | ||
Secondary | Number and grade of Participants with Adverse Events | 6 months |
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