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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
Must not have
Prior history of inflammatory bowel disease
Prior abdominal or pelvic irradiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 3 and 1 year
Awards & highlights

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of inflammatory bowel disease.
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I have had radiation therapy to my abdomen or pelvis before.

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 2023 Phase 3 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)

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 3
~130

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for cervical cancer include surgery, radiation therapy, and chemotherapy. Surgery involves the physical removal of cancerous tissue, which is crucial for early-stage cervical cancer. Radiation therapy uses high-energy rays to kill cancer cells by damaging their DNA, preventing them from growing and dividing. Hypofractionated radiotherapy, a form of radiation therapy, delivers higher doses of radiation over a shorter period, potentially killing more tumor cells and reducing side effects. Chemotherapy uses drugs to kill cancer cells or stop them from dividing. These treatments are vital for cervical cancer patients as they target and eliminate cancer cells, reduce the risk of recurrence, and improve survival rates. Hypofractionated radiotherapy, in particular, offers the advantage of shorter treatment times and potentially fewer side effects, which can significantly enhance the patient's quality of life during and after treatment.
Human papillomavirus-associated oropharynx cancer (HPV-OPC): treatment options.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,337 Total Patients Enrolled
University of UtahLead Sponsor
1,110 Previous Clinical Trials
1,788,492 Total Patients Enrolled
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
Cervical Cancer Research Study Groups: Treatment (hypo-fractionated radiotherapy)
Cervical 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
~20 spots leftby Nov 2025