Hydrogel Packing System for Cervical Cancer

N/A

Waitlist Available

Led By Kara Romano

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

FIGO IB1 - IVB Staging according to FIGO and TNM guidelines

Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1

Must not have

Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the cancer of interest

Known contraindications to brachytherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up fractions/radiation treatments 2 - 5: about 1-4 weeks after starting brachytherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, low cost packing system for brachytherapy to see if it is as effective as the standard options, and to understand any associated discomfort and safety concerns.

Who is the study for?

This trial is for adults over 18 with cervical cancer who are planning to receive brachytherapy. They must have a performance status indicating they can carry out daily activities and agree to lifestyle considerations during the study. Those with prior pelvic radiation, hysterectomy, or pregnant/lactating individuals cannot participate.

What is being tested?

The study compares a new low-cost packing system called 'BrachyGel VHPS' against standard options used in high-dose-rate (HDR) brachytherapy for cervical cancer. It aims to ensure BrachyGel VHPS protects nearby organs from radiation effectively and assesses patient safety and comfort.

What are the potential side effects?

While specific side effects of BrachyGel VHPS aren't detailed, potential risks may include discomfort at the application site, possible allergic reactions to materials in the hydrogel, and typical brachytherapy-related side effects like localized pain or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cervical cancer is between stages IB1 and IVB.

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I am mostly able to care for myself and carry out daily activities.

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I am planning to undergo brachytherapy for my cervical cancer treatment.

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My biopsy shows I have cervical cancer.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for external beam radiation therapy as my main cancer treatment.

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I cannot have brachytherapy due to health reasons.

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I have had a hysterectomy.

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I have had radiation therapy in my pelvis or abdomen not related to my current cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ fractions/radiation treatments 2 - 5: about 1-4 weeks after starting brachytherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~fractions/radiation treatments 2 - 5: about 1-4 weeks after starting brachytherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and fractions/radiation treatments 2 - 5: about 1-4 weeks after starting brachytherapy for reporting.