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Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer (CRTCOESC)

H

Henan University of Science and Technology

Status and phase

Active, not recruiting
Phase 3

Conditions

Stage III Esophageal Squamous Cell Carcinoma
Stage II Esophageal Squamous Cell Carcinoma

Treatments

Radiation: Radiotherapy
Drug: Oxaliplatin(Aiheng)
Drug: Capecitabine(Aibin)

Study type

Interventional

Funder types

Other

Identifiers

NCT02025036
FirstHenanUST

Details and patient eligibility

About

A three-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. Because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical.

The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.

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 three groups.Experimental group 1 : single drug Capecitabine and concurrent radiotherapy.Experimental group 2: Capecitabine plus oxaliplatin and concurrent radiotherapy. Control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. To evaluate the adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.

Enrollment

249 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age 18-75years 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)

249 participants in 3 patient groups

Capecitabine-oxaliplatin-radiotherapy
Experimental group
Description:
oxaliplatin:65mg/m2,d1,8,22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total. radiotherapy: 50-50.4Gy ,1.8-2 Gy/d,5d/w.
Treatment:
Drug: Capecitabine(Aibin)
Drug: Oxaliplatin(Aiheng)
Radiation: Radiotherapy
cisplatin with 5-FU and radiotherapy
Active Comparator group
Description:
cisplatin: 75mg/m2 d1,29 or d1, 29, 57, 85, 5-Fu:750mg/m2 CIV24h d1-4,d29-32 or d1-4,d29-32, d57-60, d85-88. radiotherapy: 50-50.4Gy ,1.8-2 Gy/d,5d/w.
Treatment:
Radiation: Radiotherapy
Capecitabine and radiotherapy
Experimental group
Description:
capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy: 50-50.4Gy ,1.8-2 Gy/d,5d/w.
Treatment:
Drug: Capecitabine(Aibin)
Radiation: Radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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