What side effects are associated with this type of intervention?

The most common treatments for cervical cancer, particularly those involving adaptive radiotherapy and chemoradiation, can lead to several side effects. Acute side effects often include gastrointestinal toxicity, such as nausea, vomiting, diarrhea, and abdominal pain. Hematologic toxicities like anemia, leukopenia, and thrombocytopenia are also common. Long-term side effects may include radiation-induced damage to surrounding tissues, leading to issues such as bowel obstruction, bladder dysfunction, and sexual health problems. Fatigue and skin reactions at the radiation site are also frequently reported. Personalized adaptive radiotherapy aims to minimize these side effects by adjusting the radiation dose based on patient-specific changes during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for cervical cancer, including traditional radiation therapy, chemotherapy, and targeted therapies. While adaptive radiotherapy itself is a newer approach and may not have specific FDA approvals yet, the concept builds on the foundation of intensity-modulated radiation therapy (IMRT), which is an advanced form of radiation therapy that has been approved and widely used. IMRT allows for more precise targeting of tumors, minimizing damage to surrounding healthy tissue. Additionally, drugs like cisplatin and paclitaxel are commonly used in conjunction with radiation therapy to enhance its effectiveness. These treatments aim to reduce toxicity and improve patient outcomes, aligning with the goals of adaptive radiotherapy.

What other types of research exist?

Promising novel alternatives to Adaptive Radiotherapy for cervical cancer patients include: 1) Immunotherapy, particularly immune checkpoint inhibitors like pembrolizumab, which have shown efficacy in treating advanced cervical cancer. 2) Targeted therapies, such as bevacizumab, which targets angiogenesis and has been used in combination with chemotherapy. 3) Advanced imaging techniques combined with brachytherapy, which allow for more precise targeting of radiation doses. 4) Combination therapies that integrate systemic treatments (e.g., chemotherapy or immunotherapy) with radiotherapy to enhance overall treatment efficacy.

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Radiation Therapy

Adaptive Radiation Therapy for Cervical Cancer (ARTIA-Cervix Trial)

N/A

Recruiting

Led By Kevin Moore, PhD

Research Sponsored by Varian, a Siemens Healthineers Company

Eligibility Criteria Checklist

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

Must have

No known allergy to cisplatin or compounds of similar biologic composition.

Patients must NOT have had a hysterectomy.

Must not have

Patients who undergo a pelvic or para-aortic lymph node dissection prior to planned chemoradiation therapy

Patients with a prior known history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment through 2 year follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing adaptive radiotherapy for patients with advanced cervical cancer to see if it reduces stomach-related side effects. The treatment adjusts radiation doses based on changes in the patient's body during therapy, aiming to minimize irradiation of healthy tissues while ensuring accurate delivery to the tumor.

Who is the study for?

This trial is for adults with newly diagnosed advanced cervical cancer (stages IB2-IVA) who haven't had a hysterectomy or previous cancer treatments. Participants must be planning concurrent chemo and radiation, have good performance status, no severe allergies to cisplatin, and normal organ/marrow function. They should not be pregnant/breastfeeding and must agree to use birth control.

What is being tested?

The study tests Varian Ethos Adaptive Radiation Therapy in patients with locally advanced cervical cancer. It aims to show that this individualized treatment can reduce acute gastrointestinal side effects compared to traditional non-adaptive IMRT by week 5 of external beam radiotherapy.

What are the potential side effects?

While the trial focuses on reducing gastrointestinal toxicity, potential side effects may include typical reactions from radiation therapy such as skin irritation, fatigue, nausea, diarrhea, and possibly blood count changes due to concurrent chemotherapy.

Eligibility Criteria

Inclusion Criteria

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

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I am not allergic to cisplatin or similar drugs.

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I have not had a hysterectomy.

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I have not had a hysterectomy.

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I am scheduled for both pelvic radiation and chemotherapy.

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My cervical cancer is newly diagnosed, advanced, and not spread to lymph nodes.

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My blood tests show normal organ function and I'm eligible for weekly cisplatin treatment.

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I am 18 years old or older.

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I am scheduled for both pelvic radiation and chemotherapy.

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My creatinine level is below 1.5 mg/dL.

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I am not allergic to cisplatin or similar drugs.

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I have been newly diagnosed with advanced cervical cancer without positive lymph nodes.

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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.

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

Exclusion Criteria

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

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I had surgery to remove lymph nodes in my pelvis or near my aorta before starting chemoradiation.

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I have or had a fistula connecting my bladder, bowel, or colon to my vagina.

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I have a history of inflammatory bowel disease like ulcerative colitis or Crohn's Disease.

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I have a history of autoimmune diseases like rheumatoid arthritis or lupus.

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I do not have an active HIV infection.

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I have had radiation therapy in my pelvis, abdomen, or para-aortic lymph nodes, or any treatment for this cancer.

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I haven't had cancer treatment like chemotherapy in the last 3 years.

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I have active tuberculosis.

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My cancer has spread to the lymph nodes near my pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment through 2 year follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment through 2 year follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through 2 year follow up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acute Patient Reported Outcome (PRO) GI Toxicity

Secondary study objectives

Acute PRO Bowel Toxicity

Acute PRO Urinary Toxicity

CTCAE Toxicities

+6 more

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: Daily Adaptive External Beam Radiation TherapyExperimental Treatment1 Intervention

Daily adaptive radiation therapy delivered with Varian Ethos treatment system.

0 / 23Eligibility 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 radiation therapy and chemoradiation. Radiation therapy works by using high-energy rays to destroy cancer cells, while chemoradiation combines chemotherapy with radiation to enhance the effectiveness of both. Adaptive radiotherapy, a personalized form of radiation therapy, adjusts the radiation dose and targeting based on patient-specific changes during treatment, such as tumor shrinkage or movement. This approach aims to maximize the destruction of cancer cells while minimizing damage to surrounding healthy tissue, potentially reducing acute gastrointestinal toxicity and improving overall treatment outcomes. This personalized adjustment is crucial for cervical cancer patients as it can lead to more effective and safer treatment, tailored to their individual needs.

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