← Back to Search

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

Summary

This trial is designed to show that a new type of radiation therapy for cervical cancer will result in less severe gastrointestinal side effects than a standard radiation therapy.

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.Check my eligibility
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.See study design
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
Select...
I am not allergic to cisplatin or similar drugs.
Select...
I have not had a hysterectomy.
Select...
I have not had a hysterectomy.
Select...
I am scheduled for both pelvic radiation and chemotherapy.
Select...
My cervical cancer is newly diagnosed, advanced, and not spread to lymph nodes.
Select...
My blood tests show normal organ function and I'm eligible for weekly cisplatin treatment.
Select...
I am 18 years old or older.
Select...
I am scheduled for both pelvic radiation and chemotherapy.
Select...
My creatinine level is below 1.5 mg/dL.
Select...
I am not allergic to cisplatin or similar drugs.
Select...
I have been newly diagnosed with advanced cervical cancer without positive lymph nodes.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
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:
Select...
I had surgery to remove lymph nodes in my pelvis or near my aorta before starting chemoradiation.
Select...
I have or had a fistula connecting my bladder, bowel, or colon to my vagina.
Select...
I have a history of inflammatory bowel disease like ulcerative colitis or Crohn's Disease.
Select...
I have a history of autoimmune diseases like rheumatoid arthritis or lupus.
Select...
I do not have an active HIV infection.
Select...
I have had radiation therapy in my pelvis, abdomen, or para-aortic lymph nodes, or any treatment for this cancer.
Select...
I haven't had cancer treatment like chemotherapy in the last 3 years.
Select...
I have active tuberculosis.
Select...
My cancer has spread to the lymph nodes near my pelvis.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Patient Reported Outcome (PRO) GI Toxicity
Secondary outcome measures
Acute PRO Bowel Toxicity
Acute PRO Urinary Toxicity
CTCAE Toxicities
+6 more

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.

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.
Risk and response adapted de-intensified treatment for HPV-associated oropharyngeal cancer: Optima paradigm expanded experience.Individualized Adaptive Stereotactic Body Radiotherapy for Liver Tumors in Patients at High Risk for Liver Damage: A Phase 2 Clinical Trial.

Find a Location

Who is running the clinical trial?

Varian, a Siemens Healthineers CompanyLead Sponsor
30 Previous Clinical Trials
7,128 Total Patients Enrolled
Kevin Moore, PhDPrincipal InvestigatorUniversity of California, San Diego
Jyoti Mayadev, MDPrincipal InvestigatorUniversity of California, San Diego
2 Previous Clinical Trials
92 Total Patients Enrolled

Media Library

Varian Ethos Adaptive Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05197881 — N/A
Cervical Cancer Research Study Groups: Daily Adaptive External Beam Radiation Therapy
Cervical Cancer Clinical Trial 2023: Varian Ethos Adaptive Radiation Therapy Highlights & Side Effects. Trial Name: NCT05197881 — N/A
Varian Ethos Adaptive Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05197881 — N/A
~56 spots leftby May 2026