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A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma

This study is currently recruiting participants.
Verified March 2007 by Sun Yat-sen University
Sponsor:
Collaborators:
Cancer Hospital of Shantou University
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
Fudan University
Zhejang cancer hospital
Tai Zhou Hospital of Zhejiang Province
The Second People's Hospital of Sichuan
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01216527
First received: October 6, 2010
Last updated: March 12, 2012
Last verified: March 2007
History of Changes
  Purpose

The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery versus surgery, in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.


Condition Intervention Phase
Squamous Cell Esophageal Carcinoma
 Procedure: Neo-adjuvant Chemoradiotherapy followed by Surgery
Procedure: surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery Versus Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Survival rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Disease free survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Survival rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • toxicities of neo-adjuvant chemoradiotherapy [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0).

  • assessment in perioperation [ Time Frame: perioperative period ] [ Designated as safety issue: Yes ]
    Removal rate， Time of operation， Quantity of bleeding， Thoracic Drainage， Days of Hospitalization， Rate of Operative Complication， Mortality of perioperation，

  • efficacy of neo-adjuvant chemoradiotherapy [ Time Frame: 2 weeks after neo-adjuvant chemoradiotherapy ] [ Designated as safety issue: No ]
    Criteria:Response Evaluation Criteria in Solid Tumors，RECIST


Estimated Enrollment: 640
Study Start Date: June 2007
Estimated Study Completion Date: August 2014
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental group
Neo-adjuvant Chemoradiotherapy followed by Surgery
 Procedure: Neo-adjuvant Chemoradiotherapy followed by Surgery

  1. Radiotherapy combined with concomitant chemotherapy:

    Radiotherapy Program:External radiation with a total dose of 40.0Gy is given in 20 fractions of 2.0Gy,5 fractions a week.

    neo-chemotherapy program: Navelbine 25mg/m2, IV (in the vein) on day 1 and day 8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle;or Cisplatin 25mg/m2,IV DRIP on day 1 to day 4 of each 21 day cycle.

    Number of cycles:two

  2. surgery:Mckeown Modification Surgery ang total two-field lymphadenectomy
Active Comparator: control group
only Surgery
 Procedure: surgery
two field lymphadenectomy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable.
  2. Patients must not have received any prior anticancer therapy.
  3. More than 6 months of expected survival.
  4. Age ranges from 18 to 70 years.
  5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
  6. Karnofsky performance status more than 90.
  7. Signed informed consent document on file.

Exclusion Criteria:

  1. Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.
  2. Patients with concomitant hemorrhagic disease.
  3. Pregnant or breast feeding.
  4. Inability to use gastric conduit after esophagectomy because of a prior surgery.
  5. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
  6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216527

Contacts
Contact: Fu Jian Hua, professor 86-20-87343638 fujh@sysucc.org.cn
Contact: Ting Lin, study nurse 86-20-87343628 linting@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen Uniersity Cancer Center Recruiting
GuangZhou, Guangdong, China, 510060
Contact: Jian Hua Fu, Professor     86-20-87343638     fujh@sysucc.org.cn    
Contact: Kong Jia Luo, doctor     86-20-87343258     luokj@sysucc.org.cn    
Principal Investigator: Jian Hua Fu, Professor            
Cancer Hospital of Shantou University Medical College Recruiting
Shantou, Guangdong, China, 515000
Contact: Yu Ping Chen, professor         stchenyp@hotmail.com    
Principal Investigator: Yu Ping Chen, Professor            
Sponsors and Collaborators
Sun Yat-sen University
Cancer Hospital of Shantou University
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
Fudan University
Zhejang cancer hospital
Tai Zhou Hospital of Zhejiang Province
The Second People's Hospital of Sichuan
Investigators
Principal Investigator: Jian Hua Fu, Professor Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Jianhua Fu, Sun Yat-sen University Cancer Canter
ClinicalTrials.gov Identifier: NCT01216527     History of Changes
Other Study ID Numbers: 2007048
Study First Received: October 6, 2010
Last Updated: March 12, 2012
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Stage IIB or III squamous cell esophageal carcinoma.

Additional relevant MeSH terms:
Carcinoma
Esophageal Diseases
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013