Squamous Cell Esophageal CarcinomaPhase 2NACRFMIENCT02188615
Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer
A Phase 2 study testing Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE, Cisplatin and Mckeown MIE in people with Squamous Cell Esophageal Carcinoma, run by Chengchu Zhu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Esophageal Carcinoma
- What is being tested?
- Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE, Cisplatin and Mckeown MIE
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Thaizhou Hospital
Linhai, Zhejiang, 317000
Cheng chu Zhu, professor, +86-576-85199876, zhucc669266@163.com
Bao fu Chen, professor
About this study
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
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.
Read the 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.
- Conditions
- Squamous Cell Esophageal Carcinoma
- Being tested
- Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE, Cisplatin, Mckeown MIE
- Keywords
- Squamous Cell Esophageal Carcinoma, minimally invasive esophagectomy, laparoscopy, thoracoscopy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIEProcedure or surgery
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
CisplatinDrug
Also called vinorelbine
only Radical Chemoradiotherapy
Mckeown MIEDevice
Also called Thoracoscopy, Laparoscopy
only Mckeown MIE using thoracoscopy and laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE Receives: Procedure: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE |
| Radical Chemoradiotherapy | Active comparator | only Radical Chemoradiotherapy Receives: Drug: Cisplatin |
| Mckeown MIE | Active comparator | only Mckeown MIE Receives: Device: Mckeown MIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: 1 years
Disease free survival
Measured: 5years
Overall survival rate
Measured: 3years
Overall survival rate
Measured: 5years
Secondary outcomes (8)
the opportunity of MIE after neo-adjuvant chemoradiotherapy
Criteria:Response Evaluation Criteria in Solid Tumors，RECIST
Measured: 4 weeks after completion of radiotherapy
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
Measured: 2 weeks after completion of radiotherapy
Duration of surgery
The time between the start of surgery until the end of surgery
Measured: Intraoperative
Quantity of bleeding
The amount of bleeding during surgery
Measured: Intraoperative
number of lymph nodes retrieved
The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area
Measured: Intraoperative
Days of postoperative stay
Participants will be followed for the duration of hospital stay after surgery, an expected average of 12 days
Measured: The duration of hospital stay after surgery, an expected average of 12 days
Rate of Operative Complication
Measured: 30 days after surgery
Mortality of perioperation
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJun 2011
- Primary completionJun 2015 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Esophageal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengchu Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Fudan University
- Responsible party
- Sponsor-investigator, Chengchu Zhu, Taizhou Hospital
- Investigators
- Cheng chu Zhu, professor, Study chair, Taizhou HospitalBao fu Chen, professor, Study director, Taizhou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188615
- Sponsor's protocol ID
- BZhang
- Other IDs
- 2011C13039-2
- Acronym
- NACRFMIE
- Status last verified
- Jul 2014
- First submitted
- 28 Jun 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02188615
- Acronym / sponsor ID
- NACRFMIE / BZhang
- Conditions
- Squamous Cell Esophageal Carcinoma
- Keywords
- Squamous Cell Esophageal Carcinoma, minimally invasive esophagectomy, laparoscopy, thoracoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chengchu ZhuUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Fudan University
- Study start
- Jun 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIENeo-adjuvant Chemoradiotherapy followed by Mckeown MIE |
| Radical Chemoradiotherapy | Active comparator | Drug: Cisplatinonly Radical Chemoradiotherapy |
| Mckeown MIE | Active comparator | Device: Mckeown MIEonly Mckeown MIE |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo-adjuvant Chemoradiotherapy followed by Mckeown MIENeo-adjuvant Chemoradiotherapy followed by Mckeown MIE | Procedure or surgery | experimental group |
| CisplatinAlso: vinorelbineonly Radical Chemoradiotherapy | Drug | Radical Chemoradiotherapy |
| Mckeown MIEAlso: Thoracoscopy, Laparoscopyonly Mckeown MIE using thoracoscopy and laparoscopy | Device | Mckeown MIE |
Primary outcome
Overall survival rate
Time frame: 1 years
Disease free survival
Time frame: 5years
Overall survival rate
Time frame: 3years
Overall survival rate
Time frame: 5years
8 secondary outcomes
the opportunity of MIE after neo-adjuvant chemoradiotherapy
Time frame: 4 weeks after completion of radiotherapy
Side effects of neo-adjuvant chemoradiotherapy
Time frame: 2 weeks after completion of radiotherapy
Duration of surgery
Time frame: Intraoperative
Quantity of bleeding
Time frame: Intraoperative
number of lymph nodes retrieved
Time frame: Intraoperative
Days of postoperative stay
Time frame: The duration of hospital stay after surgery, an expected average of 12 days
Rate of Operative Complication
Time frame: 30 days after surgery
Mortality of perioperation
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng chu Zhu, professor study chair
Taizhou Hospital
Bao fu Chen, professor study director
Taizhou Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE, Cisplatin and Mckeown MIE in people with Squamous Cell Esophageal Carcinoma, run by Chengchu Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng chu Zhu, professor (86-576-85199876, zhucc669266@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: 1 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.