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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment through 2 year follow up

Awards & highlights

ARTIA-Cervix Trial 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.

ARTIA-Cervix Trial 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.

ARTIA-Cervix Trial 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

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

+5 more

ARTIA-Cervix 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 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Varian, a Siemens Healthineers CompanyLead Sponsor

30 Previous Clinical Trials

7,148 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this investigation currently available?

"Patient enrollment is ongoing as evidenced by the clinicaltrials.gov listing, which was first posted on May 3rd 2022 and updated lastly on June 7th 2022."

Answered by AI

What is the upper-limit of participants in this experiment?

"This clinical trial necessitates 125 suitable test subjects to be recruited, who match the designated inclusion criteria. People can enroll at medical centres like University of Alabama Birmingham in Birmingham or University of Texas Southwestern in Dallas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix

2022. "Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05197881.