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Radiation Therapy

Hypofractionated Radiotherapy for Cancer (RT-PACE Trial)

N/A
Recruiting
Led By Gita Suneja, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have non-metastatic disease as determined by clinical exam or computed tomography (CT) or positron emission tomography (PET)/CT imaging
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 3 and 1 year
Awards & highlights

RT-PACE Trial Summary

This trial is testing whether delivering more radiation over a shorter time period is more effective in treating cervical or endometrial cancer with fewer side effects.

Who is the study for?
This trial is for adults over 18 with cervical or endometrial cancer, who've had a hysterectomy and are in good health post previous cancer treatments. They must be able to consent, have an ECOG status of <=2, non-metastatic disease, and a life expectancy over 2 years. Those with recent other cancers or certain medical conditions can't join.Check my eligibility
What is being tested?
The study tests hypo-fractionated radiotherapy for cervical/endometrial cancer treatment. This method uses higher radiation doses given in a shorter time frame than traditional therapy, aiming to kill more tumor cells while reducing side effects.See study design
What are the potential side effects?
While the trial aims to reduce side effects by using high-dose short-term radiation therapy, potential risks may include skin irritation at the treatment site, fatigue, mild digestive issues and possible impact on nearby organs.

RT-PACE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has not spread to distant parts of my body, confirmed by scans.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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I had a hysterectomy for cervical or endometrial cancer.

RT-PACE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 3 and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 3 and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to administer clinical trial to evaluate hypofractionated radiotherapy
Change in toxicity
Secondary outcome measures
Change in COST-FACIT Measure of Financial Toxicity
Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
Change in gastrointestinal toxicities as collected through Patient-Reported Outcomes instruments (PRO-CTCAE)
+3 more

Side effects data

From 2022 Phase 2 trial • 107 Patients • NCT03324802
80%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

RT-PACE Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (hypo-fractionated radiotherapy)Experimental Treatment1 Intervention
Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,331 Total Patients Enrolled
75 Trials studying Endometrial Cancer
72,425 Patients Enrolled for Endometrial Cancer
University of UtahLead Sponsor
1,092 Previous Clinical Trials
1,732,928 Total Patients Enrolled
3 Trials studying Endometrial Cancer
83 Patients Enrolled for Endometrial Cancer
Gita Suneja, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Media Library

Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05139368 — N/A
Endometrial Cancer Research Study Groups: Treatment (hypo-fractionated radiotherapy)
Endometrial Cancer Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT05139368 — N/A
Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139368 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for volunteers to join this research at present?

"According to the data posted on clinicaltrials.gov, this trial is still enlisting participants. The initial posting occurred on 11th November 2021 and was last revised on 1st March 2022."

Answered by AI

What is the sampling size of this research project?

"Affirmative. According to the clinicaltrials.gov website, enrollment is open for this experiment which was initially advertised on November 11th 2021 and last modified on March 1st 2022. 64 volunteers must be recruited from a single medical center."

Answered by AI

What is the primary objective of this clinical trial?

"The primary purpose of this trial, which will be conducted over Baseline to week 3 of pelvic radiotherapy, is to assess the efficacy of hypofractionated radiotherapy. Auxiliary objectives include assessing financial toxicity with a Comprehensive Score for Financial Toxicity, making use of Decision Regret Scale and looking at changes in Functional Assessment of Cancer Therapy-Cervix (all using 90% confidence intervals)."

Answered by AI
~25 spots leftby Nov 2025