NCT02630056

Brief Summary

The purpose of this study is to validate the dosimetric parameters that correlate with acute hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Status
unknown

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

First Submitted

Initial submission to the registry

November 27, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 15, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

November 27, 2015

Last Update Submit

December 14, 2015

Conditions

Rectal Neoplasm

Keywords

radiotherapy hematologic toxicity pelvic bone marrow

Outcome Measures

Primary Outcomes (1)

  • the grade of acute hematologic toxicity

    Hematologic Adverse Events That Are Related to Pelvic Bone Marrow Irradiation

    5-6 weeks

Eligibility Criteria

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

Both gender is OK and there is no limitation for age.

You may qualify if:

  • rectal cancer
  • receive neoadjuvant chemoradiotherapy

You may not qualify if:

  • hematological system disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 15, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

December 15, 2015

Record last verified: 2015-11