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Radiation Therapy
Ultrafractionated Radiation Therapy for Cervical Cancer
Phase 2
Recruiting
Led By Chika. Nwachukwu, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to give radiation to patients with cervical cancer that has spread. They hope this will improve how long patients live.
Who is the study for?
This trial is for adults over 18 with newly diagnosed stage IVB cervical cancer that has spread, and who are within 6 months of starting systemic therapy. Participants must have a performance status indicating they can care for themselves (ECOG 0-3) and be able to consent. Women must use birth control during the study. Those with treated or treatable brain metastases may join, but not if they've had pelvic radiation or have certain uncontrolled illnesses.
What is being tested?
The trial tests ultra-fractionated radiation therapy aimed at improving survival in patients with metastatic cervical cancer. It focuses on treating the local region where the cancer started to see if this approach helps alongside standard systemic treatments.
What are the potential side effects?
Potential side effects include skin irritation, fatigue, nausea, diarrhea, bladder issues due to radiation exposure; specific risks will depend on individual health conditions and treatment areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine if image guided ultra-fractionated stereotactic adaptive radiotherapy in metastatic/locally recurrent cervical cancer will improve overall survival outcomes
Secondary study objectives
To determine the acute and late genitourinary (GU) and gastrointestinal (GI) toxicities
To evaluate the local-regional progression after treatment
Other study objectives
To determine QOL in patients treated with radiation
To determine the treatment response after each pulse of radiation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Safety Lead InExperimental Treatment1 Intervention
An interim safety evaluation will be conducted in a minimum of 10 assessable patients who received at least 3 radiation treatments (pulses) with 90 days follow up after radiation OR who experience a dose-limiting toxicity, as defined below. Patients not meeting these requirements will still count towards the overall trial enrollment target, however, the safety lead-in will continue until 10 fully assessable patients are reached (estimate 17 total patients needed for 40% attrition). These patients initially will be enrolled to the base dose-level of 8.5Gy/fraction.
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Who is running the clinical trial?
Elekta LimitedIndustry Sponsor
10 Previous Clinical Trials
8,852 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,080 Previous Clinical Trials
1,056,283 Total Patients Enrolled
Chika. Nwachukwu, MDPrincipal InvestigatorUT Southwestern Medical Cente
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation treatment to my pelvic area.I do not have active inflammatory bowel or collagen vascular disease, nor am I on immunosuppressants.I can care for myself but may not be able to do heavy physical work.My brain cancer cannot be treated with surgery or radiation.I am 18 years old or older.I have advanced cervical cancer and started treatment within the last 6 months.My brain metastasis is stable or treatable with surgery or radiation.I agree to use birth control during and 90 days after my treatment.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Lead In
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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