Clinical trial NCT02188615: Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Cell Esophageal Carcinoma
Keywords: Squamous Cell Esophageal Carcinoma
minimally invasive esophagectomy
laparoscopy
thoracoscopy
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Fudan University
First posted: 2014-07-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Overall survival rate
timeFrame: 1 years
measure: Disease free survival
timeFrame: 5years
measure: Overall survival rate
timeFrame: 3years
measure: Overall survival rate
timeFrame: 5years
Secondary outcomes:
measure: the opportunity of MIE after neo-adjuvant chemoradiotherapy
timeFrame: 4 weeks after completion of radiotherapy
measure: Side effects of neo-adjuvant chemoradiotherapy
timeFrame: 2 weeks after completion of radiotherapy
measure: Duration of surgery
timeFrame: Intraoperative
measure: Quantity of bleeding
timeFrame: Intraoperative
measure: number of lymph nodes retrieved
timeFrame: Intraoperative
measure: Days of postoperative stay
timeFrame: The duration of hospital stay after surgery, an expected average of 12 days
measure: Rate of Operative Complication
timeFrame: 30 days after surgery
measure: Mortality of perioperation
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Linhai
country: China
facility: Thaizhou Hospital
state: Zhejiang
Study officials:
affiliation: Taizhou Hospital
name: Cheng chu Zhu, professor
role: STUDY_CHAIR
affiliation: Taizhou Hospital
name: Bao fu Chen, professor
role: STUDY_DIRECTOR
References: