Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma

Gastric Cancer Clinical Trial

— NEWEAR  

Official title:

Phase II Study of Neoadjuvant Chemotherapy Wtih S1+Oxaliplatin (SOX) Regimen Followed by Chemoradiation Concurrent With S-1 in Patients With Potentially Resectable Gastric Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02024217
• Other study ID #: LAGCCS001
• Status: Recruiting
• Phase: Phase 2
• First received: April 5, 2013
• Last updated: December 25, 2013
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: December 2013
• Source: Fudan University
• Contact: Guichao Li, MD
• Phone: 862164175590
• Email: 11111230012[@]fudan.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Königsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with local — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	resection rate	6-8 weeks after Radiation therapy,we evaluate the lesion,if it is resectable,we will give surgical therapy,	6-8 Weeks	Yes
Other	disease-free survival	after surgical therapy,we followup the patients and stat the recurrence and death and calculate the disease-free survival	up to 36 months	Yes
Other	over-all survival	after surgical therapy,we followup the patients and stat the recurrence and death and calculate the over-all survival	up to 36 months	Yes
Primary	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	Yes
Secondary	safety and tolerability of the treatment regimen	after neoadjuvant chemotherapy and chemoradiotherapy,we evaluate the side effects , and record the side effects	up to 10 weeks	Yes