NCT01381913

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

June 27, 2011

Status Verified

October 1, 2005

Enrollment Period

3.2 years

First QC Date

June 22, 2011

Last Update Submit

June 23, 2011

Conditions

Gastric CancerChemoradiation

Keywords

Gastric cancerChemoradiotherapyAdjacent tissue invasionFeasibility trial

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University

Kita, Kagawa-ken, 761-0793, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Shinichi Yachida, M. D. Ph. D.

    Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan

    STUDY DIRECTOR

  • Yasuyuki Suzuki, M. D. Ph. D.

    Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 27, 2011

Study Start

October 1, 2005

Primary Completion

December 1, 2008

Study Completion

May 1, 2011

Last Updated

June 27, 2011

Record last verified: 2005-10

Locations

JP(1)