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Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer (NACRFMIE)

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ClinicalTrials.gov Identifier: NCT02188615
Recruitment Status : Unknown
Verified July 2014 by Chengchu Zhu, Taizhou Hospital.
Recruitment status was:  Recruiting
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Collaborators:
Sun Yat-sen University
Fudan University
Information provided by (Responsible Party):
Chengchu Zhu, Taizhou Hospital

Study Description
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Brief Summary:
The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.

Condition or disease Intervention/treatment Phase
Squamous Cell Esophageal Carcinoma Procedure: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE Drug: Cisplatin Device: Mckeown MIE Phase 2

Detailed Description:

Esophageal cancer is one of the most difficult malignancies to cure. Surgical resection remains the primary treatment for localized esophageal cancer. It increases the chances of cure and alleviates the symptoms of dysphagia compared with nonoperative methods. Advances in surgical techniques and equipments have made minimally invasive esophagectomy (MIE) more popular and wider application since 1990s. During the past two decades, MIE has progressively been accepted as an alternative treatment for esophageal cancer around the world. The prognosis has some improvement on account of these significant advances in surgical techniques and perioperative management, But the prognosis of patients with locally advanced esophageal cancer remains 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.

Based on our preliminary study, we have demonstrated the validity and safety of vinorelbine and cisplatin-based neoadjuvant chemoradiotherapy. Then we are to carry out a clinical trial to investigate the effect of this multidisciplinary therapy, by comparing neo-adjuvant chemoradiotherapy followed by Mckeown MIE versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Institution Prospective Randomized Controlled Clinical Trial of Neo-adjuvant Chemoradiotherapy Followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE for Locally Advanced Squamous Cell Esophageal Carcinoma
Study Start Date : June 2011
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : July 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental group
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
 Procedure: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
Active Comparator: Radical Chemoradiotherapy
only Radical Chemoradiotherapy
 Drug: Cisplatin
only Radical Chemoradiotherapy
Other Name: vinorelbine
Active Comparator: Mckeown MIE
only Mckeown MIE
 Device: Mckeown MIE
only Mckeown MIE using thoracoscopy and laparoscopy
Other Names:
  • Thoracoscopy
  • Laparoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: 1 years ]
  2. Disease free survival [ Time Frame: 5years ]
  3. Overall survival rate [ Time Frame: 3years ]
  4. Overall survival rate [ Time Frame: 5years ]

Secondary Outcome Measures :
  1. the opportunity of MIE after neo-adjuvant chemoradiotherapy [ Time Frame: 4 weeks after completion of radiotherapy ]
    Criteria:Response Evaluation Criteria in Solid Tumors，RECIST

  2. Side effects of neo-adjuvant chemoradiotherapy [ Time Frame: 2 weeks after completion of radiotherapy ]
    Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0

  3. Duration of surgery [ Time Frame: Intraoperative ]
    The time between the start of surgery until the end of surgery

  4. Quantity of bleeding [ Time Frame: Intraoperative ]
    The amount of bleeding during surgery

  5. number of lymph nodes retrieved [ Time Frame: Intraoperative ]
    The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area

  6. Days of postoperative stay [ Time Frame: The duration of hospital stay after surgery, an expected average of 12 days ]
    Participants will be followed for the duration of hospital stay after surgery, an expected average of 12 days

  7. Rate of Operative Complication [ Time Frame: 30 days after surgery ]
  8. Mortality of perioperation [ Time Frame: 30 days after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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): NCT02188615


Contacts
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Contact: Cheng chu Zhu, professor 86-576-85199876 zhucc669266@163.com
Contact: min Kong, master 86-576-85199101 kongm@enzemed.com

Locations
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China, Zhejiang
Thaizhou Hospital Recruiting
Linhai, Zhejiang, China, 317000
Contact: Cheng chu Zhu, professor    +86-576-85199876    zhucc669266@163.com   
Principal Investigator: Bao fu Chen, professor         
Sponsors and Collaborators
Chengchu Zhu
Sun Yat-sen University
Fudan University
Investigators
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Study Chair: Cheng chu Zhu, professor Taizhou Hospital
Study Director: Bao fu Chen, professor Taizhou Hospital
More Information
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Responsible Party: Chengchu Zhu, Division Director, Taizhou Hospital
ClinicalTrials.gov Identifier: NCT02188615    
Other Study ID Numbers: BZhang
2011C13039-2 ( Other Grant/Funding Number: Zhejiang Provincial Science and Technology Major Projects )
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Keywords provided by Chengchu Zhu, Taizhou Hospital:
Squamous Cell Esophageal Carcinoma
minimally invasive esophagectomy
laparoscopy
thoracoscopy
Additional relevant MeSH terms:
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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
Vinorelbine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action