Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

NCT ID: NCT03211377

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-29

Study Completion Date

2021-04-29

Brief Summary

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This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction

Detailed Description

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Conditions

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Esophagogastric Junction Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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neoadjuvant therapy group

Preoperation chemotherapy treatment for patients up to four cycles

No interventions assigned to this group

adjuvant therapy

Postoperation chemotherapy treatment for patients up to six cycles

No interventions assigned to this group

Perioperative therapy

Preoperation chemotherapy treatment for patients up to four cycles and postoperation chemotherapy up to six cycles

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytological proved locally advanced esophagogastric junction cancer
* ECOG performance status ≦2
* Stage IIa-IIIc
* No distant metastasis (M0)
* Sign in Informed Consent Form

Exclusion Criteria

* History of hypersensitivity to fluoropyrimidines, Tegafur,Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
* Pregnancy or lactation women,
* Inadequate hematopoietic function: WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
* Inadequate organ function which is defined as below:

Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN); serum creatinine \> 1.5 mg/dL, and Ccr \> 60 ml/min (estimated by Cockcroft-Gault formulation);

* Symptomatic peripheral neuropathy
* Receiving a concomitant treatment with other fluoropyrimidines
* Fluoropyrimidines (DPD) congenital absence
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anyang Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of science and education

Anyang, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Baozhong

Role: CONTACT

0372-2923314

Facility Contacts

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Wang, MD

Role: primary

0372-2923314

Other Identifiers

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TOTMSEJ1701

Identifier Type: -

Identifier Source: org_study_id

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