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

Phase 2

• Conditions: Squamous Cell Esophageal Carcinoma
• Interventions: Device: Mckeown MIE; Procedure: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE; Drug: Cisplatin

• Registration Number: NCT02188615
• Lead Sponsor: Chengchu Zhu

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.

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2014-06-28
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11
• Primary Completion: 2015-06
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mckeown MIE	Mckeown MIE	only Mckeown MIE
experimental group	Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE	Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
Radical Chemoradiotherapy	Cisplatin	only Radical Chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
Overall survival rate	5years
Disease free survival	5years

Secondary Outcome Measures

Name	Time	Method
Side effects of neo-adjuvant chemoradiotherapy	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
the opportunity of MIE after neo-adjuvant chemoradiotherapy	4 weeks after completion of radiotherapy	Criteria:Response Evaluation Criteria in Solid Tumors，RECIST
Days of postoperative stay	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
Mortality of perioperation	30 days after surgery
Rate of Operative Complication	30 days after surgery
Duration of surgery	Intraoperative	The time between the start of surgery until the end of surgery
Quantity of bleeding	Intraoperative	The amount of bleeding during surgery
number of lymph nodes retrieved	Intraoperative	The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area

Trial Locations

Locations (1)

Thaizhou Hospital; 🇨🇳 Linhai, Zhejiang, China