Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer

June 23, 2011 updated by: Kagawa University

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kagawa
      • Kita, Kagawa, Japan, 761-0793
        • Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kagawa University

Investigators

  • Study Director: Shinichi Yachida, M. D. Ph. D., Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan
  • Principal Investigator: Yasuyuki Suzuki, M. D. Ph. D., Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 23, 2011

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NACRT-GC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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