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Chemotherapy

Accelerated Brachytherapy + Chemo Radiation for Cervical Cancer

Phase 1 & 2

Recruiting

Led By Jessika A Contreras, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Newly diagnosed biopsy proven FIGO (2018) clinical stage IB3-IVA cervical carcinoma

Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix

Must not have

Any prior pelvic radiotherapy

Any prior gynecologic or other pelvic malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 year follow-up (estimated to be 2 years and 6 weeks)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the effects of using a combination of brachytherapy and hypofractionated radiation as an initial treatment for cervical cancer. The goal is to see how this treatment impacts side

Who is the study for?

This trial is for individuals with locally advanced cervical cancer (stages IB3-IVA). Participants must be eligible to receive chemotherapy and radiation. Specific details about inclusion and exclusion criteria are not provided, but typically these would outline health requirements and any factors that could interfere with treatment or skew results.

What is being tested?

The study tests a new approach called ABC-RT which combines upfront brachytherapy (a type of internal radiation) with hypofractionated external beam radiation, alongside standard chemotherapy. The goal is to see if this method can improve outcomes while reducing treatment time.

What are the potential side effects?

Potential side effects may include gastrointestinal issues like nausea or diarrhea, genitourinary problems such as bladder irritation or urinary incontinence, fatigue from chemotherapy, and localized reactions from the radiation therapy.

Eligibility Criteria

Inclusion Criteria

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

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I have been newly diagnosed with stage IB3 to IVA cervical cancer.

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My cervical cancer is one of three types: squamous, adenocarcinoma, or adenosquamous.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

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

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I have had radiation therapy to my pelvic area before.

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I have had cancer in my reproductive or pelvic area before.

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My cancer has spread beyond the pelvic area.

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I have had a hysterectomy or will have one as part of my cervical cancer treatment.

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I have not had major surgery in the last 3 weeks or have fully recovered from one before that.

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I do not have any serious, uncontrolled health conditions or infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 year follow-up (estimated to be 2 years and 6 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 year follow-up (estimated to be 2 years and 6 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 year follow-up (estimated to be 2 years and 6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participant

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: Accelerated Brachytherapy Forward Chemo Radiation TherapyExperimental Treatment3 Interventions

Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) combines hypofractionated external beam radiation therapy (EBRT) with concurrent chemotherapy and early upfront, image-guided brachytherapy. In this study, patients start with 2 fractions of brachytherapy prior to initiation of EBRT-based chemoradiotherapy. Total time from treatment planning is approximately 36-42 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Image-guided brachytherapy

2011

Completed Phase 2

~100