Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

NCT03211377 | Unknown

• 1 other identifier: TOTMSEJ1701
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophagogastric Junction Cancer

Outcome Measures

Primary Outcomes (1)

• disease free survival(DFS)

  time from surgery to disease recurrence or death

  up to 3 years

Secondary Outcomes (2)

• Overall survival (OS)

  up to 5 years

• Adverse events(AE)

  through study completion, up to 1 year

Study Arms (3)

neoadjuvant therapy group

Preoperation chemotherapy treatment for patients up to four cycles

adjuvant therapy

Postoperation chemotherapy treatment for patients up to six cycles

Perioperative therapy

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

Eligibility Criteria

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

Study Population

For this study patients had to be at least 18 years old with histologically or cytologically confirmed locally advanced esophagogastric junction cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anyang Tumor Hospital: lead

Study Sites (1)

Department of science and education

Anyang, Henan, China

RECRUITING

Central Study Contacts

Li Baozhong

CONTACT

0372-2923314; drlibaozhong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 7, 2017
• Study Start: March 29, 2017
• Primary Completion: March 29, 2019
• Study Completion: April 29, 2021
• Last Updated: July 11, 2017

Record last verified: 2017-06

Locations

CN (1)