Accelerated Brachytherapy + Chemo Radiation for Cervical Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jessika Contreras, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Washington University School of Medicine

Disqualifiers: Prior pelvic radiotherapy, other malignancy, metastatic disease, hysterectomy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The standard treatment for locally advanced cervical cancer is well established as a combination of chemotherapy and radiation, typically over 25-28 daily fractions with the addition of a brachytherapy boost to the primary tumor. An important component to treatment efficacy is overall treatment time. Prolongation of overall treatment time has been shown to lead to worse local control and overall survival; thus, strategies to effectively deliver radiation efficiently is required. This is a pragmatic feasibility study to determine the impact of upfront brachytherapy combined with hypofractionated external beam radiation for patients with locally advanced cervical cancer (FIGO 2018 stage IB3-IVA) on late gastrointestinal and genitourinary toxicity, oncologic outcomes including recurrence free survival, and systemic and local immune response.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Accelerated Brachytherapy + Chemo Radiation for Cervical Cancer?

Research shows that using high-dose-rate brachytherapy (a type of internal radiation) with external beam radiation therapy and chemotherapy is effective for treating advanced cervical cancer, improving survival rates and patient outcomes.

^{1 2 3 4 5}

Is accelerated brachytherapy with chemo radiation generally safe for humans?

Research shows that high-dose-rate brachytherapy combined with external beam radiation and chemotherapy is commonly used for treating cervical cancer, and studies have focused on patient outcomes and toxicities. This suggests that the treatment has been evaluated for safety, although specific safety data details are not provided in the abstracts.

^{1 3 6 7 8}

How is the Accelerated Brachytherapy + Chemo Radiation treatment for cervical cancer different from other treatments?

This treatment combines high-dose-rate brachytherapy (a type of internal radiation) with chemotherapy and hypofractionated external beam radiation (a method that delivers larger doses of radiation over fewer sessions), which may improve local control and survival rates compared to traditional low-dose-rate brachytherapy and standard radiation schedules.

^{1 2 3 8 9}

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

My oncologist has approved me for targeted radiation therapy.

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

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

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

Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test day of or within 7 days prior to simulation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Brachytherapy

Participants receive 2 fractions of brachytherapy prior to initiation of EBRT-based chemoradiotherapy

1 week

Chemoradiotherapy

Participants receive hypofractionated external beam radiation therapy (EBRT) with concurrent chemotherapy

5-6 weeks

Follow-up

Participants are monitored for late gastrointestinal and genitourinary toxicity, oncologic outcomes, and immune response

2 years and 6 weeks

Participant Groups

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.

Group I: Accelerated Brachytherapy Forward Chemo Radiation Therapy Experimental Treatment 3 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.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

🇺🇸 Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

🇨🇦 Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

🇯🇵 Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

🇨🇳 Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

🇨🇭 Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Washington University School of Medicine Saint Louis, MO

Who Is Running the Clinical Trial?

Washington University School of Medicine Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

The Impact of High-Dose-Rate Brachytherapy: Measuring Clinical Outcomes in the Primary Treatment of Cervical Cancer. [2022] Radical concurrent chemoradiotherapy with combined external beam radiotherapy (EBRT) and brachytherapy is used to treat locally advanced cervical cancer. Our institution has transitioned to high-dose-rate (HDR) intracavitary brachytherapy (ICBT) from low-dose-rate (LDR) brachytherapy in 2008, and a review was conducted on the effect of this change on patient outcomes.

2. Germany pubmed.ncbi.nlm.nih.gov

Primary radiotherapy of stage IIA/B-IIIB cervical carcinoma. A comparison of continuous versus sequential regimens. [2006] Comprehensive literature on cervical cancer demonstrates, even today, the need for optimization of the timing of external-beam radiotherapy (EBRT) and high-dose-rate brachytherapy (HDR-BT) in the treatment of stage IIA/B-IIIB cervical carcinoma.

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Brachytherapy utilization rate and effect on survival in cervical cancer patients in Korea. [2021] External beam radiation therapy (EBRT) with concurrent chemotherapy followed by intracavitary brachytherapy is the standard treatment in locally advanced cervical cancer. This study examined the brachytherapy utilization rate and evaluated the effect of brachytherapy on survival in cervical cancer patients in Korea.

4. India pubmed.ncbi.nlm.nih.gov

Radical radiotherapy treatment (EBRT + HDR-ICRT) of carcinoma of the uterine cervix: outcome in patients treated at a rural center in India. [2019] To report the outcome of carcinoma of the uterine cervix patients treated radically by external beam radiotherapy (EBRT) and high-dose-rate (HDR) intracavitary radiotherapy (ICRT).

5. United States pubmed.ncbi.nlm.nih.gov

Radical External-Beam Radiotherapy in Combination With Intracavitary Brachytherapy for Localized Carcinoma of the Cervix in Sri Lanka: Is Treatment Delayed Treatment Denied? [2021] Radical external-beam radiotherapy (EBRT) followed by intracavitary brachytherapy is standard of care for patients with localized carcinoma of the cervix unsuitable for radical surgery. However, outcome data are scarce in resource-limited settings. We conducted a retrospective analysis of survival in a cohort of patients treated with this strategy in Sri Lanka.

6. United States pubmed.ncbi.nlm.nih.gov

Outcome of 6 fractions of 5.3 Gray HDR brachytherapy in combination with external beam radiotherapy for treatment of cervical cancer. [2018] To review the characteristics, outcomes and toxicities of cervical cancer patients treated with 6 fractions of brachytherapy after external beam radiotherapy (EBRT).

7. United States pubmed.ncbi.nlm.nih.gov

Multifractionated high-dose-rate brachytherapy with concomitant daily teletherapy for cervical cancer. [2019] High-dose-rate (HDR) brachytherapy has been the preferred treatment for cervical cancer at Wayne State University since 1987. The outcome of the first 105 patients treated is analyzed.

8. England pubmed.ncbi.nlm.nih.gov

Brachytherapy versus radical hysterectomy after external beam chemoradiation: a non-randomized matched comparison in IB2-IIB cervical cancer patients. [2022] A current paradigm in the treatment of cervical cancer with radiation therapy is that intracavitary brachytherapy is an essential component of radical treatment. This is a matched retrospective comparison of the results of treatment in patients treated with external beam chemoradiation (EBRT-CT) and radical hysterectomy versus those treated with identical chemoradiation followed by brachytherapy.

9. France pubmed.ncbi.nlm.nih.gov

[Curietherapy in uterine cervix cancers: what therapeutic trends?]. [2019] Brachytherapy is a fundamental step in the treatment of patients with cervical cancer. Brachytherapy allows a significant increase in the local control rate as well as the survival rate. Brachytherapy has to be performed as soon as possible after external irradiation in order to maintain the overall treatment time below 53 days. Technical and dosimetric data characterizing low dose-rate brachytherapy using ICRU 38 recommendations have led to an improvement in local control and a decrease in complications. Data are less well known for other dose rates. The role of interstitial brachytherapy is not clearly defined and its potential benefit is probably balanced by an increase in severe complications. Concomitant brachy-chemotherapy requires further clinical investigations, even if concomitant radio-chemotherapy has become a standard in advanced cervical cancers.