NCT01671683

Brief Summary

The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant chemotherapy with capecitabine during the resting periods in patients with locally advanced rectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

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

July 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

First QC Date

August 21, 2012

Last Update Submit

August 21, 2012

Conditions

Rectal Cancer

Keywords

rectal cancerneoadjuvant chemoradiotherapyCapecitabine

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients of our hospital

You may qualify if:

  • histologically proven, locally advanced adenocarcinoma of the rectum
  • an Eastern Cooperative Oncology Group (ECOG) score of 0-2
  • adequate function of major organs
  • a signed informed consent.

You may not qualify if:

  • other co-existing malignancy or malignancy within the last 5 years prior to enrollment
  • severe concurrent medical or psychiatric disorders
  • prior RT to pelvis
  • pregnant or lactating patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ji Yeon Kim, MD., PhD

    Surgical Oncology Research Lab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 21, 2012

First Posted

August 23, 2012

Study Start

July 1, 2010

Study Completion

September 1, 2011

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

KR(1)