Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02603159
Other study ID # Capecitabine and esophageal
Secondary ID
Status Recruiting
Phase Phase 3
First received November 9, 2015
Last updated November 9, 2015
Start date October 2014
Est. completion date December 2019

Study information

Verified date October 2015
Source The First Affiliated Hospital of Henan University of Science and Technology
Contact Shegan Gao, Doctor
Phone 18638859977
Email gsg112258@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

Definitive chemoradiotherapy with cisplatin 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, Capecitabine is widely used in the chemotherapy of esophageal cancer.

The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.


Description:

We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2019
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Capecitabine(Aibin)
Capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total
Radiation:
radiotherapy
Concurrent radiotherapy: 50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity

Locations

Country Name City State
China The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Henan University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (1)

Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival, OS 2 years Yes
Secondary progression-free survival 2 years Yes
Secondary overall remission rate, ORR 16 weeks Yes
Secondary serious adverse event 16 weeks Yes
Secondary quality of life, Qol 16 weeks No
Secondary pathologic complete response rate 16 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT02628665 - Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer Phase 3
Recruiting NCT02607540 - Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer Phase 3
Recruiting NCT02604615 - The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy Phase 3
Active, not recruiting NCT02025036 - Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer Phase 3
Completed NCT02644408 - Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy Phase 3
Recruiting NCT02812641 - Neoadjuvant CCRT With/Without Bevacizumab for Locally Advanced ESCC Phase 2
Completed NCT02459457 - A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer Phase 3