What side effects are associated with this type of intervention?

Common treatments for cervical cancer, such as hypofractionated radiotherapy, can lead to side effects including acute gastrointestinal toxicity, fatigue, and skin reactions. Hypofractionated radiotherapy, which delivers higher doses over a shorter period, may reduce long-term side effects but can still cause acute reactions. Concurrent chemoradiation, often used in treatment, can add side effects like nausea, vomiting, and hematologic toxicity. Long-term effects may include bowel and bladder dysfunction, sexual dysfunction, and, in some cases, secondary cancers.

What prior FDA approvals exist?

The FDA has approved several treatments for cervical cancer, including chemotherapeutic agents like cisplatin and paclitaxel, often used in combination with radiation therapy. Hypofractionated radiotherapy, which delivers higher doses of radiation over a shorter period, is being studied for its potential to kill more tumor cells and reduce side effects. While specific FDA approvals for hypofractionated radiotherapy in cervical cancer are not detailed, the approach aligns with the broader trend of optimizing radiation therapy to improve outcomes and minimize toxicity.

What other types of research exist?

Promising novel alternatives to hypofractionated radiotherapy for cervical cancer patients include: 1) Concurrent chemoradiation with novel agents such as immune checkpoint inhibitors, which have shown potential in enhancing the immune response against cancer cells. 2) Targeted therapies that focus on specific molecular pathways involved in cervical cancer progression. 3) Advanced brachytherapy techniques that deliver precise radiation doses directly to the tumor while sparing surrounding healthy tissue. These approaches aim to improve treatment outcomes and reduce side effects.

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Radiation Therapy

Hypofractionated Radiotherapy for Cancer (RT-PACE Trial)

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

Summary

This trial studies using stronger doses in fewer sessions to treat cervical or endometrial cancer. It aims to kill more cancer cells and reduce 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.

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.

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:

Select...

I have a history of inflammatory bowel disease.

Select...

I have had radiation therapy to my abdomen or pelvis before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 3 and 1 year

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

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

Primary study objectives

Ability to administer clinical trial to evaluate hypofractionated radiotherapy

Change in toxicity

Secondary study objectives

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

Skin hypopigmentation

Edema limbs

Device related infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1 (Radiation Therapy, 15 Fractions)

Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

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: 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

0 / 6Eligibility criteria met

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.