Intensity-modulated radiation therapy for Cancer of Rectum

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Cancer of Rectum+1 More
Intensity-modulated radiation therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this research study is to find out how safe and effective is treating patients with locally advanced rectal cancer (LARC) with chemotherapy first and then follow with radiation therapy to a higher dose than what is usually delivered and see if patients could have complete response and be spared from surgery.

Eligible Conditions

  • Cancer of Rectum
  • Rectal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Disease-free Survival (DFS) rate
Overall Survival (OS)
Percentage of Participants with Documented Distant Metastasis
Percentage of Participants with Documented Local Control
Up to 30 months
Health-related Quality of Life (HRQOL) Scores: Patient-Reported Outcomes Measurement Information System (PROMIS)
Health-related Quality of Life (HRQOL) Scores: Pittsburgh Sleep Quality Index (PSQI)
Incidence of Acute and Long-Term Toxicity After Start of Study Therapy
Incidence of Toxicity Among Participants After Start Receiving MRI-g Pelvic ART
Up to 6 months
Percentage of Real Negatives

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

SMART TNT Plan I
1 of 2
SMART TNT Plan II
1 of 2
Experimental Treatment

25 Total Participants · 2 Treatment Groups

Primary Treatment: Intensity-modulated radiation therapy · No Placebo Group · Phase 1

SMART TNT Plan IExperimental Group · 5 Interventions: Intensity-modulated radiation therapy, Leucovorin, 5-fluorouracil, Oxaliplatin, Capecitabine · Intervention Types: Radiation, Drug, Drug, Drug, Drug
SMART TNT Plan II
Radiation
Experimental Group · 1 Intervention: Accelerated Radiation Therapy · Intervention Types: Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-modulated radiation therapy
2006
Completed Phase 3
~1230
Leucovorin
2014
Completed Phase 4
~5100
5-fluorouracil
2005
Completed Phase 4
~7820
Oxaliplatin
2003
Completed Phase 4
~4430
Capecitabine
2002
Completed Phase 3
~3010

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: University of Miami · Miami, FL
Photo of University of Miami 1Photo of University of Miami 2Photo of University of Miami 3
1991First Recorded Clinical Trial
0 TrialsResearching Cancer of Rectum
621 CompletedClinical Trials

Who is running the clinical trial?

University of MiamiLead Sponsor
780 Previous Clinical Trials
381,737 Total Patients Enrolled
Lorraine Portelance, MDPrincipal InvestigatorUniversity of Miami

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a primary tumor located ≤ 18 cm from margin verge.
You are 18 years of age or older.\n
You have liver function tests within the range of 1.5 x Upper Limit of Normal (within 6 weeks of enrollment).
You are of child-bearing potential.
You are able to understand the nature and purpose of the study and the risks and benefits of participating in the study.
You have a performance status of 0-2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.