NCT03151759

Brief Summary

To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2002

Longer than P75 for all trials

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 6, 2002

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2007

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

4.4 years

First QC Date

May 10, 2017

Last Update Submit

May 10, 2017

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Matrilysin levels

    Inflammatory markers

    1 - 6 weeks

Study Arms (3)

No radiotherapy

Surgery only

25 Gray radiotherapy

Surgery after short term radiotherapy

Radiation: Neoadjuvant radiotherapy

50 Gray radiotherapy

Surgery after long term radiotherapy

Radiation: Neoadjuvant radiotherapy

Interventions

Neoadjuvant radiotherapyRADIATION

Neoadjuvant radiotherapy prior to rectal cancer surgery

25 Gray radiotherapy50 Gray radiotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Rectal cancer patients undergoing surgery with or without neoadjuvant radiotherapy

You may qualify if:

  • Adenocarcinoma of the rectum, ability to understand written and oral information, written consent.

You may not qualify if:

  • Colon cancer, benign tumors, impaired general condition of patient, declining to participate in the study, synchronous colonic tumors, logistical reasons, inability to understand written and/or oral information, previous pelvic irradiation, ongoing immunosuppressive therapy, diabetes with systemic complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Design

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

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 12, 2017

Study Start

November 6, 2002

Primary Completion

March 16, 2007

Study Completion

March 16, 2007

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share