A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT01591135
- Lead Sponsor
- Fudan University
- Brief Summary
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.
- Detailed Description
Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a，TxNxM1a （according to AJCC2002）
Scheme:
Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio.
Arm Cisplatin:
Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.
Arm Paclitaxel:
Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 436
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cisplatin Cisplatin plus 5-fluorouracil Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles. Cisplatin Radiation therapy Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles. Paclitaxel Radiation therapy Patients randomized in Arm B will receive chemoradiation with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy with paclitaxel and 5-fluorouracil for 2 cycles. Paclitaxel Paclitaxel plus 5-fluorouracil Patients randomized in Arm B will receive chemoradiation with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy with paclitaxel and 5-fluorouracil for 2 cycles.
- Primary Outcome Measures
Name Time Method 3-yr overall survival 3 years
- Secondary Outcome Measures
Name Time Method Disease progression-free survival 3 years Local progression-free survival 3 years Number and grade of Participants with Adverse Events 6 months
Trial Locations
- Locations (1)
Fudan University Cancer Center
🇨🇳Shanghai, Shanghai, China