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Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01216527
Recruitment Status : Unknown
Verified February 2017 by Jianhua Fu, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : October 7, 2010
Last Update Posted : February 27, 2017
Sponsor:
Collaborators:
Affiliated Cancer Hospital of Shantou University Medical College
Shanghai Chest Hospital
Fudan University
Zhejiang Cancer Hospital
Taizhou Hospital
The Second People's Hospital of Sichuan
Tianjin Medical University Cancer Institute and Hospital
Information provided by (Responsible Party):
Jianhua Fu, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE October 6, 2010
First Posted Date  ICMJE October 7, 2010
Last Update Posted Date February 27, 2017
Study Start Date  ICMJE June 2007
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2013)
Overall survival rate [ Time Frame: 3 and 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2010)
  • Survival rate [ Time Frame: 3 years ]
  • Disease free survival [ Time Frame: 10 years ]
  • Survival rate [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2013)
  • toxicities of neo-adjuvant chemoradiotherapy [ Time Frame: 56 days ]
    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 ]
    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: 4 weeks after completion of radiotherapy ]
    Criteria:Response Evaluation Criteria in Solid Tumors,RECIST
  • Disease free survival rate [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2010)
  • toxicities of neo-adjuvant chemoradiotherapy [ Time Frame: 56 days ]
    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 ]
    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 ]
    Criteria:Response Evaluation Criteria in Solid Tumors,RECIST
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer
Official Title  ICMJE A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery Versus Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma
Brief Summary 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.
Detailed Description

Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 480,000 new cases and 400,000 deaths occurred annually worldwide. In China, every year, no matter new cases or deaths account for more than half of the world. Besides, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).

Surgery is the main treatment of this disease, but the prognosis of patients with locally advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.

Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the survival of EC. Nevertheless, the results of different studies were inconsistent. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. It should be noticed that only 84 cases(23%) of ESCC were enrolled in this trial with potential minimal follow-up of 2 years, which may be not perfect to evaluate the effect of this combined therapy for this tumor type.

Up till now, vinorelbine has no indications for esophageal cancer, although, some studied have reported its effect and feasibility to the therapy of EC. Vinorelbine has similar mechanism with paclitaxel and docetaxel, which are recommended for the chemotherapy of EC by NCCN. They are all classified as antimicrotubule agents, which cause mitotic arrest and eventual cell death through inhibition of microtubule dynamics. In comparison with the taxanes, vinorelbine has obvious advantage of few cardiac toxicity. This should be beneficial to prevent cardiac side effects of chemoradiotherapy, especially for the middle or lower thoracic EC, which account for over 70% of thoracic EC in China. For this group of patients, radiotherapy can hardly avoid cardiac toxicity.

Based on our preliminary study, we have demonstrated the validity and safety of vinorelbine and cisplatin-based neoadjuvant chemoradiotherapy.

We are to carry out a phased III clinical trial to investigate the effect of this multidisciplinary therapy for the overall survival of patients with locally advanced ESCC.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Esophageal Carcinoma
Intervention  ICMJE
  • 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: Vinorelbine 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 and total two-field lymphadenectomy
  • Procedure: surgery
    two field lymphadenectomy
Study Arms  ICMJE
  • Experimental: experimental group
    Neo-adjuvant Chemoradiotherapy followed by Surgery
    Intervention: Procedure: Neo-adjuvant Chemoradiotherapy followed by Surgery
  • Active Comparator: control group
    only Surgery
    Intervention: Procedure: surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 15, 2013)
430
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2010)
640
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (KPS) of 90 or more.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01216527
Other Study ID Numbers  ICMJE 2007048
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jianhua Fu, Sun Yat-sen University
Original Responsible Party Jianhua Fu, Sun Yat-sen University Cancer Canter
Current Study Sponsor  ICMJE Sun Yat-sen University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Affiliated Cancer Hospital of Shantou University Medical College
  • Shanghai Chest Hospital
  • Fudan University
  • Zhejiang Cancer Hospital
  • Taizhou Hospital
  • The Second People's Hospital of Sichuan
  • Tianjin Medical University Cancer Institute and Hospital
Investigators  ICMJE
Principal Investigator: Jian-hua Fu, Professor Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP