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

NCT02188615 | Unknown Phase 2 DMC

• 2 other identifiers: BZhang2011C13039-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Esophageal Carcinoma

Keywords

Squamous Cell Esophageal Carcinoma; minimally invasive esophagectomy; laparoscopy; thoracoscopy

Outcome Measures

Primary Outcomes (4)

• Overall survival rate

  1 years

• Disease free survival

  5years

• Overall survival rate

  3years

• Overall survival rate

  5years

Secondary Outcomes (8)

• the opportunity of MIE after neo-adjuvant chemoradiotherapy

  4 weeks after completion of radiotherapy

• Side effects of neo-adjuvant chemoradiotherapy

  2 weeks after completion of radiotherapy

• Duration of surgery

  Intraoperative

• Quantity of bleeding

  Intraoperative

• number of lymph nodes retrieved

  Intraoperative

Study Arms (3)

experimental group

EXPERIMENTAL

Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE

Procedure: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE

Radical Chemoradiotherapy

ACTIVE COMPARATOR

only Radical Chemoradiotherapy

Drug: Cisplatin

Mckeown MIE

ACTIVE COMPARATOR

only Mckeown MIE

Device: Mckeown MIE

Interventions

Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE PROCEDURE

Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE

experimental group

Cisplatin DRUG

only Radical Chemoradiotherapy

Also known as: vinorelbine

Radical Chemoradiotherapy

Mckeown MIE DEVICE

only Mckeown MIE using thoracoscopy and laparoscopy

Also known as: Thoracoscopy, Laparoscopy

Mckeown MIE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengchu Zhu: lead
• Sun Yat-sen University: collaborator
• Fudan University: collaborator

Study Sites (1)

Thaizhou Hospital

Linhai, Zhejiang, 317000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Cisplatin; Vinorelbine; Thoracoscopy; Laparoscopy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Cheng chu Zhu, professor

  Taizhou Hospital

  STUDY CHAIR

• Bao fu Chen, professor

  Taizhou Hospital

  STUDY DIRECTOR

Central Study Contacts

Cheng chu Zhu, professor

CONTACT

86-576-85199876; zhucc669266@163.com

min Kong, master

CONTACT

86-576-85199101; kongm@enzemed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Director

Study Record Dates

• First Submitted: June 28, 2014
• First Posted: July 11, 2014
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2019
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

CN (1)