Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma

Phase 2

• Conditions: Gastric Cancer
• Interventions: Radiation: S1，oxaliplatin，radiation

• Registration Number: NCT02024217
• Lead Sponsor: Fudan University

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).

Detailed Description

The prognosis of gastric cancer is poor partially due to low R0 resection rate. Neoadjuvant chemoradiotherapy was reported to be effective in this setting by several phase II studies. The investigators aim to evaluate the efficacy and toxicity of neoadjuvant chemoradiotherapy in a prospective phase II study.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-04-05
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-25
• Last Update Submitted: 2013-12-25
• Study First Posted: 2013-12-31
• Last Update Posted: 2013-12-31
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.18 ≤ 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.

Exclusion Criteria

1. Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment;
2. Female patients who planed to have a baby;
3. Prior radiation therapy to the stomach, liver or kidney;
4. Dysfunction of important organs such as liver, kidney or heart; 5.Abnormalities of mental status;

6.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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemoradiotherapy, S1, oxaliplatin	S1，oxaliplatin，radiation	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.

Primary Outcome Measures

Name	Time	Method
R0 resection rate	6-8 Weeks	6-8 weeks after Radiation therapy，we evaluate the lesion，if it is resectable，we will give surgical therapy，

Secondary Outcome Measures

Name	Time	Method
safety and tolerability of the treatment regimen	up to 10 weeks	after neoadjuvant chemotherapy and chemoradiotherapy，we evaluate the side effects , and record the side effects

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China