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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01216527
First Posted: October 7, 2010
Last Update Posted: February 27, 2017
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.
Collaborators:
Cancer Hospital of Shantou University
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
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


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

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: 3 and 5 years ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 430
Study Start Date: June 2007
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (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: 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
Active Comparator: control group
only Surgery
Procedure: surgery
two field lymphadenectomy

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 (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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216527


Locations
China, Guangdong
Sun Yat-sen Uniersity Cancer Center
GuangZhou, Guangdong, China, 510060
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515000
Sponsors and Collaborators
Sun Yat-sen University
Cancer Hospital of Shantou University
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
Principal Investigator: Jian-hua Fu, Professor Sun Yat-sen University
  More Information

Publications:
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
Herskovic A, Russell W, Liptay M, Fidler MJ, Al-Sarraf M. Esophageal carcinoma advances in treatment results for locally advanced disease: review. Ann Oncol. 2012 May;23(5):1095-103. doi: 10.1093/annonc/mdr433. Epub 2011 Oct 14. Review.
van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
Kulke MH, Muzikansky A, Clark J, Enzinger PC, Fidias P, Kinsella K, Michelini A, Fuchs CS. A Phase II trial of vinorelbine in patients with advanced gastroesophageal adenocarcinoma. Cancer Invest. 2006 Jun-Jul;24(4):346-50.
Airoldi M, Cortesina G, Giordano C, Pedani F, Bumma C, Gabriele P. Docetaxel and vinorelbine: an effective regimen in recurrent squamous cell esophageal carcinoma. Med Oncol. 2003;20(1):19-24.
Koussis H, Scola A, Bergamo F, Tonello S, Basso U, Karahontzitis P, Chiarion-Sileni V, Pasetto L, Ruol A, Loreggian L, Lora O, Bottin R, Marioni G, Donach M, Jirillo A. Neoadjuvant carboplatin and vinorelbine followed by chemoradiotherapy in locally advanced head and neck or oesophageal squamous cell carcinoma: a phase II study in elderly patients or patients with poor performance status. Anticancer Res. 2008 Mar-Apr;28(2B):1383-8.
Yang H, Fu JH, Hu Y, Lin P, Liu MZ, Li Q, Fang ZC, Hu YH. [Neo-adjuvant chemoradiotherapy followed by surgery in treatment of advanced esophageal carcinoma]. Zhonghua Yi Xue Za Zhi. 2008 Dec 9;88(45):3182-5. Chinese.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jianhua Fu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01216527     History of Changes
Other Study ID Numbers: 2007048
First Submitted: October 6, 2010
First Posted: October 7, 2010
Last Update Posted: February 27, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases


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