Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal squamous cell carcinoma, chemoradiotherapy
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.
Interventions
DRUGPaclitaxel plus 5-fluorouracil
5-fluorouracil 300 mg/m2, d1-4, continuous infusion for 96 hours and paclitaxel 50 mg/m2 over 3 hours, d1 (week 1, week 2, week 3, week 4 and week 5); 5-fluorouracil 600 mg/m2/d d1-3 and paclitaxel 175 mg/m2 d1(week 9 and week 13).
DRUGCisplatin plus 5-fluorouracil
cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).
RADIATIONRadiation therapy
A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
Sponsors
Jiangsu Cancer Institute & Hospital
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Xiamen University
Fujian Cancer Hospital
Affiliated Hospital of Jiangnan University
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-yr overall survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Disease progression-free survival | 3 years |
| Local progression-free survival | 3 years |
| Number and grade of Participants with Adverse Events | 6 months |
Countries
China
Outcome results
None listed