A Trial of Neoadjuvant Chemotherapy for Stage II, III Eso... | NCT02915965

Studies
A Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma

NCT02915965

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Sep 27, 2016Estimated

Enrollment

80Estimated

Phase

Phase 2

Conditions

Stage II and III Esophageal Squamous Cell Carcinoma

Interventions

DCX
surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2018Estimated

Completion Date

Not provided

First Submitted Date

Sep 23, 2016

First Submission Date that Met QC Criteria

Sep 24, 2016

First Posted Date

Sep 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regional esophageal squamous cell carcinoma (ESCC).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DCX and surgery	Experimental	docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by surgery of Ivor Lewis Esophagectomy	Drug: DCX Procedure: surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DCX	Drug	docetaxel, cisplatin and capecitabine	DCX and surgery
surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival rate		2 years

Secondary Outcomes

Measure	Description	Time Frame
Pathologic response rate	Pathologic response rate is defined as tumor regression score	2 years
Disease-free survival		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II 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.

Exclusion Criteria:

Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine.
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 common toxicity criterion (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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanhong Deng, MD PHD	Contact	+86020 38379762		dengyanh@mail.sysu.edu.cn
Jiayu Ling, MD	Contact	+86020 38379762		lingjiay@mail.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Yanhong Deng, MD PHD	Sixth Affiliated Hospital, Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Sixth Affiliated Hospital of Sun Yat-sen University		Guangzhou	Guangdong	510655	China