Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma

NCT02024217 | Unknown Phase 2

• 1 other identifier: LAGCCS001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the feasibility, safety and tolerability of Preoperative Chemoradiation in Patients With Localized Gastric Cancer. Primary endpoint: R0 resection rate. Secondary endpoint: resection rate, pathological complete regression (pCR), effectiveness and safety of regime, disease free survival(DFS) and overall survival(OS).

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  6-8 weeks after Radiation therapy，we evaluate the lesion，if it is resectable，we will give surgical therapy，

  6-8 Weeks

Secondary Outcomes (1)

• safety and tolerability of the treatment regimen

  up to 10 weeks

Other Outcomes (3)

• resection rate

  6-8 Weeks

• disease-free survival

  up to 36 months

• over-all survival

  up to 36 months

Study Arms (1)

chemoradiotherapy, S1, oxaliplatin

EXPERIMENTAL

chemoradiotherapy is given before surgical therapy,S1(Tegafur，Gimeracil and Oteracil Potassium Capsules) is given during radiation therapy and neoadjuvant chemotherapy, oxaliplatin is given during neoadjuvant chemotherapy.

Radiation: S1，oxaliplatin，radiation

Interventions

S1，oxaliplatin，radiation RADIATION

Radiation: 180 (cGy) /day, D1-5;S1: 50mg/m2,D1-5;

Also known as: S1(Tegafur，Gimeracil and Oteracil Potassium Capsules)

chemoradiotherapy, S1, oxaliplatin

Eligibility Criteria

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

You may qualify if:

• ≤ age ≤ 70, Male or Female; 2.Minimum life expectancy of 6 months; 3.Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma; 4.Patients must have a performance status of \< 2 Eastern Cooperative Oncology Group (ECOG); 5.No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy; 6.CT or MRI, endorectal ultrasonography (EUS), laparoscopic exploration are required to stage; 7.Without other benign diseases such as lung, kidney, liver infections; 8.Without participating other clinical trials; 9.Patient must sign an informed consent prior to study entry; 10.Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of \>1,500/µL, and platelet count of \> 100,000/µL), adequate liver function (bilirubin \<= 1.5 mg/dl), and adequate renal function (creatinine \<= 1.5 mg/dl). 11)Patients without cardiac disease , severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.

You may not qualify if:

• Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment;
• Female patients who planed to have a baby;
• Prior radiation therapy to the stomach, liver or kidney;
• Dysfunction of important organs such as liver, kidney or heart; 5.Abnormalities of mental status;
• Active coronary artery disease; 7.Cardiac arrhythmia, and need to receive medication therapy; 8.Severe uncontrolled hypertension; 9.Active clinical serious infection; 10.The known human immunodeficiency virus (HIV) infection history; 11.The known central nervous system diseases, including brain metastatic tumors; 12.Patients have had clinical clear gastrointestinal bleeding in 6 months; 13.Drug abuse; 14.Swallowing difficulties for drugs; 15.Poor compliance; 16.Presence of concurrent or previous malignancies (except for cervical carcinoma in situ or basal cell carcinoma of the skin); 17.Presence of peritoneal metastasis, distant organs or lymph nodes metastasis; 18.Presence history of major surgery in the past three months; 19.Poor tolerability; 20.Prior history of medication; 21.allergy for chemotherapeutic drugs.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (2)

• Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12.

  PMID: 19139439 RESULT

• Liu X, Li G, Long Z, Yin J, Zhu X, Sheng W, Huang D, Zhu H, Zhang Z, Cai H, Huang H, Zhao G, Zhou Y, Zhang Z, Wang Y. Phase II trial of preoperative chemoradiation plus perioperative SOX chemotherapy in patients with locally advanced gastric cancer. J Surg Oncol. 2018 Mar;117(4):692-698. doi: 10.1002/jso.24917. Epub 2017 Nov 30.

  PMID: 29194623 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

potassium oxonate

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Zhen Zhang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guichao Li, MD

CONTACT

862164175590; 11111230012@fudan.edu.cn

Xiaowen Liu, MD

CONTACT

liuxw1129@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Department of Radiation Oncology Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: December 31, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

CN (1)