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Trial Title:
Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer
NCT ID:
NCT02188615
Condition:
Squamous Cell Esophageal Carcinoma
Conditions: Official terms:
Carcinoma
Esophageal Neoplasms
Vinorelbine
Conditions: Keywords:
Squamous Cell Esophageal Carcinoma
minimally invasive esophagectomy
laparoscopy
thoracoscopy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
Description:
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
Arm group label:
experimental group
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
only Radical Chemoradiotherapy
Arm group label:
Radical Chemoradiotherapy
Other name:
vinorelbine
Intervention type:
Device
Intervention name:
Mckeown MIE
Description:
only Mckeown MIE using thoracoscopy and laparoscopy
Arm group label:
Mckeown MIE
Other name:
Thoracoscopy
Other name:
Laparoscopy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Thaizhou Hospital
Address:
City:
Linhai
Zip:
317000
Country:
China
Status:
Recruiting
Contact:
Last name:
Cheng chu Zhu, professor
Phone:
+86-576-85199876
Email:
zhucc669266@163.com
Investigator:
Last name:
Bao fu Chen, professor
Email:
Principal Investigator
Start date:
June 2011
Completion date:
July 2019
Lead sponsor:
Agency:
Chengchu Zhu
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Source:
Taizhou Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02188615
