Chemoradiation + EBRT Boost for Stage II Rectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Stage II Rectal CancerChemoradiation + EBRT Boost - Radiation
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying two different types of radiation therapy for rectal cancer.

Eligible Conditions
  • Stage II Rectal Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 5 years post treatment

2 years post treatment
Local Recurrence
Rectum preservation in treated patients
TME-free survival
5 years post treatment
Disease-free survival
Overall Quality of life
Overall survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Chemoradiation + EBRT Boost
1 of 2
Chemoradiation + HDRBT Boost
1 of 2

Experimental Treatment

145 Total Participants · 2 Treatment Groups

Primary Treatment: Chemoradiation + EBRT Boost · No Placebo Group · Phase 2 & 3

Chemoradiation + EBRT BoostExperimental Group · 2 Interventions: Complete responders and Non-complete responders, Chemoradiation + EBRT Boost · Intervention Types: Procedure, Radiation
Chemoradiation + HDRBT BoostExperimental Group · 2 Interventions: Complete responders and Non-complete responders, Chemoradiation + HDRBT Boost · Intervention Types: Procedure, Radiation

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years post treatment

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
52 Previous Clinical Trials
18,538 Total Patients Enrolled
Te Vuong, MDPrincipal InvestigatorSir Mortimer Jewish General Hospital
6 Previous Clinical Trials
292 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a tumor located at less than 10 cm from the anal verge.
You have a rectal cancer staged as N0 by MRI or EUS/TRUS.
You have a tumor less than 5 cm on its largest dimension.
The tumor is less than 5 mm in the mesorectal fat.
The lumen of the colon is accessible for colonoscopy.
Patient should be a suitable candidate for brachytherapy and chemotherapy.