Cervical Cancer by FIGO Stage 2018ARTIA-CervixNCT05197881
Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix
A study testing Varian Ethos Adaptive Radiation Therapy in people with Cervical Cancer by FIGO Stage 2018, run by Varian, a Siemens Healthineers Company at 5 sites in United States.
Trial summary
This is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for locally advanced cervical cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer by FIGO Stage 2018
- What is being tested?
- Varian Ethos Adaptive Radiation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 May 2022to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2018 clinical stages IB2-IVA, without involved paraaortic lymph nodes.
- For patients with involved pelvic lymph nodes, the upper border of the CTV nodal volume may not extend above the confluence of the common iliac arteries with the aorta (i.e., aortic bifurcation).
- Patients must NOT have had a hysterectomy.
- Pelvic nodal status is to be confirmed by one or more of the following studies/procedures: PET/CT scan, CT scan, MR Scan, fine needle biopsy, extra peritoneal biopsy or laparoscopic biopsy, per institutional standard of care.
- Patients must be planning to undergo concurrent pelvic radiation and chemotherapy.
- ECOG performance status ≤ 2 (Karnofsky ≥60%).
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- Patient must be willing and able to complete the PRO-CTCAE, EQ-5D, EPIC and EORTC questionnaires as described in the study protocol.
- Patient must have normal organ and marrow function as defined below:
- leukocytes ≥ 2,500/mcL
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 100,000/mcL
- hemoglobin ≥ 8 g/dL (can be transfused with red blood cells pre-study)
- total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 3 × ULN
- alkaline phosphatase ≤ 2.5 × ULN
- creatinine < 1.5 mg/dL to receive weekly cisplatin*
- Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if there is no hydronephrosis and the estimated creatinine clearance (CCr) is >30 ml/min. For the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used:CCr=(0.85 ×(140-age)×IBW)/((Scr×72)) where age is the patient's age in years (from 20 to 80 years), Scr is the serum creatinine in mg/dL, and IBW is the ideal body weight in kg (according to the calculation IBW = 45.5 kg + 2.3 kg for each inch over 5 feet).
- Age ≥ 18 years (or meets local age of consent).
- Study participant is already intending to be prescribed a standard of care cisplatin treatment regimen.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior radiation therapy to the pelvis or abdominal cavity, para-aortic lymph glands (PALN) radiation, or previous therapy of any kind for this malignancy.
- Patients with PALN nodal metastasis.
- Patients who have undergone staging pelvic and/or paraaortic lymphadenectomy.
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Prior systemic anticancer therapy due to a diagnosis of cancer (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
- Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (with the exception of DCIS of the breast, or early stage basal cell carcinoma of the skin).
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- Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease.
- Patients with a history of other symptomatic autoimmune disease: rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's Granulomatosis); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis, multiple sclerosis.).
- Patients with active tuberculosis (TB).
- Patients who are pregnant.
- Patients who are actively breastfeeding (or who do not agree to discontinue breastfeeding before the initiation of protocol therapy).
- Patients who are of child-bearing potential who do not agree to use birth control (for a minimum of 14 months after the last dose of cisplatin) in accordance with institution's standard of care.
- Patients with a prior known history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.
- Patients who undergo a pelvic or para-aortic lymph node dissection prior to planned chemoradiation therapy.
- Patients with known active infection of HIV.
- Patients with hip prosthetics
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sean Davidson, MS contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Alabama Birmingham
Burmingham, Alabama, 35233
Cody Hughes, codyhughes@uabmc.edu
Ashley Anderson, 205-975-2880, aranderson@uabmc.edu
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Sarah Neufeld, MS, 214-648-1836, sarah.hardee@utsouthwestern.edu
Kevin Albuquerque, MD, kevin.albuquerque@utsouthwestern.edu
- Recruiting
Moores Cancer Center at UC San Diego Health
La Jolla, California, 92037
Nicole Daniel, mdaniel@health.ucsd.edu
- Recruiting
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205
Santanu Samanta, MD, ssamanta@uams.edu
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Jeremy Price, MD, jeremy.price@tuhs.temple.edu
About this study
Official title: Daily Adaptive External Beam Radiation Therapy in the Treatment of Carcinoma of the Cervix: A Prospective Trial of an Individualized Approach for Intestinal Toxicity Reduction (ARTIA-Cervix)
This is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for locally advanced cervical cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT). The timepoint for this assessment will be at week 5 of external beam radiotherapy (EBRT) and will use the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
- Conditions
- Cervical Cancer by FIGO Stage 2018
- Being tested
- Varian Ethos Adaptive Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varian Ethos Adaptive Radiation TherapyDevice
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
| Study group | Role | What they receive |
|---|---|---|
| Daily Adaptive External Beam Radiation Therapy | Experimental | Daily adaptive radiation therapy delivered with Varian Ethos treatment system. Receives: Device: Varian Ethos Adaptive Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Patient Reported Outcome (PRO) GI Toxicity
GI toxicity as reported by the patient using the gastrointestinal section of the NCI-PRO questionnaire
Measured: End of external beam treatment delivery (week 5)
Secondary outcomes (9)
Key powered secondary endpoint: Fecal Urgency
Acute reported fecal urgency (as measured by the inability to defer defecation by 15 minutes)
Measured: End of external beam treatment delivery (week 5)
Acute PRO Bowel Toxicity
Bowel toxicity as reported with EPIC bowel questionnaire
Measured: End of external beam treatment delivery (week 5)
Acute PRO Urinary Toxicity
Urinary toxicity as reported with EPIC urinary questionnaire
Measured: End of external beam treatment delivery (week 5)
Patient Reported Quality by EQ-5D-5L
Quality of life as document with EQ-5D-5L patient reported questionnaire
Measured: 24 months post treatment
Patient Reported Quality by EORTC
Quality of life as document with EORTC patient reported questionnaire
Measured: 24 months post treatment
Disease-free Survival
Disease-free survival at 2 years
Measured: Enrollment through 2 year follow up
Normal Tissue Complication Probability Model
Develop a normal tissue complication probability (NTCP) model of acute GI toxicity based on true integrated daily dose to the bowel
Measured: Enrollment through 2 year follow up
Workflow Feasibility
Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT
Measured: End of external beam treatment delivery
CTCAE Toxicities
Physician reported CTCAE toxicities
Measured: Enrollment through 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start3 May 2022
- Primary completionSep 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer by FIGO Stage 2018Studies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jyoti Mayadev, MD, Principal investigator, University of California, San DiegoXenia Ray, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197881
- Sponsor's protocol ID
- VAR-2021-04
- Acronym
- ARTIA-Cervix
- Status last verified
- Sep 2025
- First submitted
- 30 Nov 2021
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Adaptive External Beam Radiation Therapy in the Treatment of Carcinoma of the Cervix: A Prospective Trial of an Individualized Approach for Intestinal Toxicity Reduction (ARTIA-Cervix)
- ClinicalTrials.gov ID
- NCT05197881
- Acronym / sponsor ID
- ARTIA-Cervix / VAR-2021-04
- Conditions
- Cervical Cancer by FIGO Stage 2018
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for locally advanced cervical cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT). The timepoint for this assessment will be at week 5 of external beam radiotherapy (EBRT) and will use the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily Adaptive External Beam Radiation Therapy | Experimental | Device: Varian Ethos Adaptive Radiation TherapyDaily adaptive radiation therapy delivered with Varian Ethos treatment system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients must have histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2018 clinical stages IB2-IVA, without involved paraaortic lymph nodes.
- For patients with involved pelvic lymph nodes, the upper border of the CTV nodal volume may not extend above the confluence of the common iliac arteries with the aorta (i.e., aortic bifurcation).
- Patients must NOT have had a hysterectomy.
- Pelvic nodal status is to be confirmed by one or more of the following studies/procedures: PET/CT scan, CT scan, MR Scan, fine needle biopsy, extra peritoneal biopsy or laparoscopic biopsy, per institutional standard of care.
- Patients must be planning to undergo concurrent pelvic radiation and chemotherapy.
Key exclusion criteria (16 listed)
- Prior radiation therapy to the pelvis or abdominal cavity, para-aortic lymph glands (PALN) radiation, or previous therapy of any kind for this malignancy.
- Patients with PALN nodal metastasis.
- Patients who have undergone staging pelvic and/or paraaortic lymphadenectomy.
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Prior systemic anticancer therapy due to a diagnosis of cancer (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varian Ethos Adaptive Radiation TherapyDaily adaptive external beam radiation therapy delivered on Varian Ethos treatment system. | Device | Daily Adaptive External Beam Radiation Therapy |
Primary outcome
Acute Patient Reported Outcome (PRO) GI Toxicity
Time frame: End of external beam treatment delivery (week 5)
GI toxicity as reported by the patient using the gastrointestinal section of the NCI-PRO questionnaire
9 secondary outcomes
Key powered secondary endpoint: Fecal Urgency
Time frame: End of external beam treatment delivery (week 5)
Acute PRO Bowel Toxicity
Time frame: End of external beam treatment delivery (week 5)
Acute PRO Urinary Toxicity
Time frame: End of external beam treatment delivery (week 5)
Patient Reported Quality by EQ-5D-5L
Time frame: 24 months post treatment
Patient Reported Quality by EORTC
Time frame: 24 months post treatment
Disease-free Survival
Time frame: Enrollment through 2 year follow up
Normal Tissue Complication Probability Model
Time frame: Enrollment through 2 year follow up
Workflow Feasibility
Time frame: End of external beam treatment delivery
CTCAE Toxicities
Time frame: Enrollment through 2 year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean Davidson, MS contact
Jyoti Mayadev, MD principal investigator
University of California, San Diego
Xenia Ray, PhD principal investigator
University of California, San Diego
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varian Ethos Adaptive Radiation Therapy in people with Cervical Cancer by FIGO Stage 2018, run by Varian, a Siemens Healthineers Company at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heike Hausen, MD (1-650-743-7400, heike.hausen@varian.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Patient Reported Outcome (PRO) GI Toxicity (time frame: End of external beam treatment delivery (week 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.