SABR boost and de-escalated chemoradiation for Human Papillomavirus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Centre Hospitalier de l'Université de Montréal, Montreal, CanadaHuman Papillomavirus+2 MoreSABR boost and de-escalated chemoradiation - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a shorter, more intense course of radiation therapy is as effective as the standard 7-week course for treating oropharynx cancer associated with the human papillomavirus.

Eligible Conditions
  • Human Papillomavirus
  • Oropharyngeal Cancers
  • Head and Neck Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: At 2- and 5-years after the end of chemoradiation

Year 2
Locoregional control
At 2- and 5-years after the end of chemoradiation
OS
PFS
Year 2
Dysphagia
Head and neck symptom burden
Month 6
Subacute toxicity
Month 6
Late toxicity
Month 2
Acute toxicity
Measured in days and reported at 2-years post-treatment
Time from treatment start to return to work

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Standard chemoradiation
1 of 2
SABR boost and de-escalated chemoradiation
1 of 2

Active Control

Experimental Treatment

106 Total Participants · 2 Treatment Groups

Primary Treatment: SABR boost and de-escalated chemoradiation · No Placebo Group · Phase 2

SABR boost and de-escalated chemoradiation
Radiation
Experimental Group · 1 Intervention: SABR boost and de-escalated chemoradiation · Intervention Types: Radiation
Standard chemoradiation
Radiation
ActiveComparator Group · 1 Intervention: Standard chemoradiation · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 2- and 5-years after the end of chemoradiation

Who is running the clinical trial?

Lawson Health Research InstituteOTHER
620 Previous Clinical Trials
403,148 Total Patients Enrolled
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
327 Previous Clinical Trials
113,781 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,824 Previous Clinical Trials
1,792,432 Total Patients Enrolled
Jewish General HospitalOTHER
135 Previous Clinical Trials
319,542 Total Patients Enrolled
David Palma, MD PhDPrincipal InvestigatorLawson Health Research Institute
Phuc-Felix Nguyen-Tan, MDStudy ChairCentre hospitalier de l'Université de Montréal (CHUM)
Jack Phan, MD PhDPrincipal InvestigatorM.D. Anderson Cancer Center
Khalil Sultanem, MDPrincipal InvestigatorMontreal Jewish General Hospital
Houda Bahig, MD PhDStudy ChairCentre hospitalier de l'Université de Montréal (CHUM)
1 Previous Clinical Trials
68 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are scheduled to receive chemotherapy and radiation therapy with the goal of curing your illness.

Frequently Asked Questions

What risks are associated with SABR boost and de-escalated chemoradiation?

"SABR boost and de-escalated chemoradiation was given a safety score of 2. This is due to the lack of efficacy data, as this is only a Phase 2 trial." - Anonymous Online Contributor

Unverified Answer

How many people are being recruited for this research project?

"That is correct, according to the clinicaltrials.gov website, this study is currently looking for participants. The trial was first posted on February 23rd 2020 and was last edited on April 24th 2022. They are hoping to enroll 106 patients at a single site." - Anonymous Online Contributor

Unverified Answer

Are volunteers being accepted for this experiment currently?

"The most recent update on clinicaltrials.gov suggests that this trial is still looking for participants. The posting date was February 23rd, 2020 and the April 24th, 2022 update confirms that recruitment is ongoing." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.