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Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer

This study has been completed.
Sponsor:
Information provided by:
Kagawa University
ClinicalTrials.gov Identifier:
NCT01381913
First received: June 22, 2011
Last updated: June 23, 2011
Last verified: October 2005
History of Changes
  Purpose

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.


Condition
Gastric Cancer
Chemoradiation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kagawa University:

Biospecimen Retention:   Samples Without DNA

tissue


Enrollment: 12
Study Start Date: October 2005
Study Completion Date: May 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Histologically proven gastric adenocarcinoma
  • Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381913

Locations
Japan
Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University
Kita, Kagawa, Japan, 761-0793
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Tatsushi Inoue, Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan
ClinicalTrials.gov Identifier: NCT01381913     History of Changes
Other Study ID Numbers: NACRT-GC
Study First Received: June 22, 2011
Last Updated: June 23, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Kagawa University:
Gastric cancer
Chemoradiotherapy
Adjacent tissue invasion
Feasibility trial

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 18, 2013