NCT00414232

Brief Summary

Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2006

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

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

3.9 years

First QC Date

December 20, 2006

Last Update Submit

November 22, 2019

Conditions

Rectal Cancer

Keywords

Rectal CancerChemoradiationRectal Cancer receiving chemoradiation.

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (QoL)

    Assessment of Quality of Life of Patients post standard of care radiation therapy

    1 year

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males or females greater than or equal to 18 years of age with a working diagnosis of rectal cancer.

You may qualify if:

  • All of the following questions must be answered "yes" for a patient to be eligible for this protocol.
  • Is there a working diagnosis of rectal cancer? YES NO
  • Will the patient be receiving neoadjuvant concurrent chemotherapy and pelvic radiation? YES NO
  • Is the pelvic radiation planned for a dose of 45-54 Gy and will it be delivered using a standard 3-field technique? YES NO
  • Is the patient ≥ 18 years of age? YES NO
  • Can the patient give informed consent? YES NO

You may not qualify if:

  • All of the following questions must be answered "no" for a patient to be eligible for this protocol.
  • Has there been prior radiation to the pelvis? YES NO
  • Is the patient in the "special category" designated by the Public Health Service (patients younger than 18, pregnant women, and prisoners)? YES NO

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Joseph Herman, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 21, 2006

Study Start

November 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

US(1)