Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer (PFCRTESC)

Henan University of Science and Technology

Status and phase: Unknown; Phase 3

Conditions: Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma

Treatments: Radiation: Radiotherapy; Other: 4 cycles cisplatin-5-fluorouracil; Other: 2 cycles cisplatin-5-fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT02607540

PF and esophageal cancer

Details and patient eligibility

About

A two-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway.

The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 210 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.

Full description

We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into two groups.Experimental group: Two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.Control group:Four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.To evaluate the overall survival of the 2 group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.

Enrollment: 210 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 45-75years old
• Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0
• The patients have not received the surgery or chemo-radiotherapy.
• Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
• ALT、AST≤2.5*N,Cr≤1.5*N.
• performance status score 0-2

Exclusion criteria

• pregnant, lactating women
• Oxaliplatin or fluorouracil Allergy or metabolic disorders
• Radiotherapy contraindications
• History of organ transplantation
• Brain metastasis
• The peripheral nervous system disorders
• Severe infection
• Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
• Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
• Other malignant tumor in recent 5 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Two cycles PF-radiotherapy

Experimental group

Description:

2 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32. radiotherapy： 50Gy，2 Gy/d，5d/w.

Treatment:

Other: 2 cycles cisplatin-5-fluorouracil

Radiation: Radiotherapy

Four cycles PF-radiotherapy

Active Comparator group

Description:

4 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29, 57, 85；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88. radiotherapy： 50Gy，2 Gy/d，5d/w.

Treatment:

Other: 4 cycles cisplatin-5-fluorouracil

Radiation: Radiotherapy