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

Arm | Intervention/treatment |
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Experimental: experimental group
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
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Procedure: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE |
Active Comparator: Radical Chemoradiotherapy
only Radical Chemoradiotherapy
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Drug: Cisplatin
only Radical Chemoradiotherapy
Other Name: vinorelbine |
Active Comparator: Mckeown MIE
only Mckeown MIE
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Device: Mckeown MIE
only Mckeown MIE using thoracoscopy and laparoscopy
Other Names:
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- Overall survival rate [ Time Frame: 1 years ]
- Disease free survival [ Time Frame: 5years ]
- Overall survival rate [ Time Frame: 3years ]
- Overall survival rate [ Time Frame: 5years ]
- the opportunity of MIE after neo-adjuvant chemoradiotherapy [ Time Frame: 4 weeks after completion of radiotherapy ]Criteria:Response Evaluation Criteria in Solid Tumors,RECIST
- 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
- Duration of surgery [ Time Frame: Intraoperative ]The time between the start of surgery until the end of surgery
- Quantity of bleeding [ Time Frame: Intraoperative ]The amount of bleeding during surgery
- number of lymph nodes retrieved [ Time Frame: Intraoperative ]The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area
- 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
- Rate of Operative Complication [ Time Frame: 30 days after surgery ]
- Mortality of perioperation [ Time Frame: 30 days after surgery ]

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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 |
Inclusion Criteria:
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable.
- Patients must not have received any prior anticancer therapy.
- More than 6 months of expected survival.
- Age ranges from 18 to 70 years.
- 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.
- Karnofsky performance status (KPS) of 90 or more.
- Signed informed consent document on file.
Exclusion Criteria:
- Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.
- Patients with concomitant hemorrhagic disease.
- Pregnant or breast feeding.
- Inability to use gastric conduit after esophagectomy because of a prior surgery.
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
- Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

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
Contact: Cheng chu Zhu, professor | 86-576-85199876 | zhucc669266@163.com | |
Contact: min Kong, master | 86-576-85199101 | kongm@enzemed.com |
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 |
Study Chair: | Cheng chu Zhu, professor | Taizhou Hospital | |
Study Director: | Bao fu Chen, professor | Taizhou Hospital |
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 |
Squamous Cell Esophageal Carcinoma minimally invasive esophagectomy laparoscopy thoracoscopy |
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 |