Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381913
• Other study ID #: NACRT-GC
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: June 23, 2011
• Start date: October 2005
• Est. completion date: May 2011

Study information

• Verified date: October 2005
• Source: Kagawa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. This feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.

Description:

Since S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) was approved in Japan in 1999 after a large-scale clinical trial, adjuvant chemotherapy with S-1 has been the standard treatment for stage II/III gastric cancer. However, for far-advanced gastric cancer, various adjuvant chemotherapies, including S-1, have not achieved satisfactory results. Therefore, Japan Clinical Oncology Group (JCOG) is currently performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) for locally far-advanced gastric cancer. However, previous studies of NAC have reported a pathological response rate of 15-50% for the main lesion, indicating no significant effect on local tumor control.

On the other hand, other studies have reported that anticancer drugs, including S-1, have a radiosensitizing effect, and that neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. Therefore, we conducted a feasibility trial of NACRT with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2011
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologically proven gastric adenocarcinoma

• Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases

• No metastases outside of Group 2 lymph nodes

• Neither peritoneal metastasis nor liver metastasis

• No other distant metastasis

• An Eastern cooperative oncology group performance status of between 0 and 2

• No prior radiation therapy

• Sufficient organ function

Exclusion Criteria:

• A synchronous or previously active malignancy

• Insufficient oral intake

• A history of severe allergy

• Watery diarrhea

• Severe co-morbidities

• Requiring therapy for pericardial effusion or pleural effusion

• Contraindications to S-1 or radiotherapy.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chemoradiation
• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Japan	Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University	Kita	Kagawa

Sponsors (1)

Lead Sponsor	Collaborator
Kagawa University

Country where clinical trial is conducted

Japan,