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

Squamous Cell Esophageal Carcinoma Clinical Trial

— NACRFMIE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02188615
• Other study ID #: BZhang
• Secondary ID: 2011C13039-2
• Status: Recruiting
• Phase: Phase 2
• First received: June 28, 2014
• Last updated: July 9, 2014
• Start date: June 2011
• Est. completion date: July 2019

Study information

• Verified date: July 2014
• Source: Taizhou Hospital
• Contact: Cheng chu Zhu, professor
• Phone: 86-576-85199876
• Email: zhucc669266[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Zhejiang Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2019
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Neoplasms
• Squamous Cell Esophageal Carcinoma

Intervention

Procedure:
• Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE

Drug:
• Cisplatin
only Radical Chemoradiotherapy

Device:
• Mckeown MIE
only Mckeown MIE using thoracoscopy and laparoscopy

Locations

Country	Name	City	State
China	Thaizhou Hospital	Linhai	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Chengchu Zhu	Fudan University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate		1 years	Yes
Primary	Disease free survival		5years	Yes
Primary	Overall survival rate		3years	Yes
Primary	Overall survival rate		5years	Yes
Secondary	the opportunity of MIE after neo-adjuvant chemoradiotherapy	Criteria:Response Evaluation Criteria in Solid Tumors,RECIST	4 weeks after completion of radiotherapy	Yes
Secondary	Side effects of neo-adjuvant chemoradiotherapy	Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0	2 weeks after completion of radiotherapy	Yes
Secondary	Duration of surgery	The time between the start of surgery until the end of surgery	Intraoperative	Yes
Secondary	Quantity of bleeding	The amount of bleeding during surgery	Intraoperative	Yes
Secondary	number of lymph nodes retrieved	The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area	Intraoperative	No
Secondary	Days of postoperative stay	Participants will be followed for the duration of hospital stay after surgery, an expected average of 12 days	The duration of hospital stay after surgery, an expected average of 12 days	No
Secondary	Rate of Operative Complication		30 days after surgery	Yes
Secondary	Mortality of perioperation		30 days after surgery	Yes