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Trial record 1 of 1 for:    VAR-2021-04
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Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix (ARTIA-Cervix)

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ClinicalTrials.gov Identifier: NCT05197881
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : August 3, 2023
Sponsor:
Information provided by (Responsible Party):
Varian, a Siemens Healthineers Company

Study Description
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Brief Summary:
This is a single-arm, prospective, Phase II, 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).

Condition or disease Intervention/treatment Phase
Cervical Cancer by FIGO Stage 2018 Device: Varian Ethos Adaptive Radiation Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daily Adaptive External Beam Radiation Therapy in the Treatment of Carcinoma of the Cervix: A Phase II Trial of an Individualized Approach for Intestinal Toxicity Reduction (ARTIA-Cervix)
Actual Study Start Date : May 3, 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Daily Adaptive External Beam Radiation Therapy
Daily adaptive radiation therapy delivered with Varian Ethos treatment system.
 Device: Varian Ethos Adaptive Radiation Therapy
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Acute PRO Bowel Toxicity [ Time Frame: End of external beam treatment delivery (week 5) ]
    Bowel toxicity as reported with EPIC bowel questionnaire

  2. Acute PRO Urinary Toxicity [ Time Frame: End of external beam treatment delivery (week 5) ]
    Urinary toxicity as reported with EPIC urinary questionnaire

  3. Patient Reported Quality by EQ-5D-5L [ Time Frame: 24 months post treatment ]
    Quality of life as document with EQ-5D-5L patient reported questionnaire

  4. Patient Reported Quality by EORTC [ Time Frame: 24 months post treatment ]
    Quality of life as document with EORTC patient reported questionnaire

  5. Disease-free Survival [ Time Frame: Enrollment through 2 year follow up ]
    Disease-free survival at 2 years

  6. Normal Tissue Complication Probability Model [ Time Frame: Enrollment through 2 year follow up ]
    Develop a normal tissue complication probability (NTCP) model of acute GI toxicity based on true integrated daily dose to the bowel

  7. Workflow Feasibility [ Time Frame: End of external beam treatment delivery ]
    Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT

  8. CTCAE Toxicities [ Time Frame: Enrollment through 2 year follow up ]
    Physician reported CTCAE toxicities


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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 positive LN.
  2. Patients must NOT have had a hysterectomy.
  3. 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.
  4. Patients must be planning to undergo concurrent pelvic radiation and chemotherapy.
  5. ECOG performance status ≤ 2 (Karnofsky ≥60%).
  6. Patient must be willing and able to complete the PRO-CTCAE, EQ-5D, EPIC and EORTC questionnaires as described in the study protocol.

  7. 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).
  8. Age ≥ 18 years.
  9. No known allergy to cisplatin or compounds of similar biologic composition.
  10. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Prior radiation therapy to the pelvis or abdominal cavity, para-aortic lymph glands (PALN) radiation, or previous therapy of any kind for this malignancy.
  2. Patients with PALN nodal metastasis.
  3. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  4. Prior systemic anticancer therapy due to a diagnosis of cancer (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
  5. 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).
  6. Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease.
  7. 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.).
  8. Patients with active tuberculosis (TB).
  9. Patients who are pregnant.
  10. Patients who are actively breastfeeding (or who do not agree to discontinue breastfeeding before the initiation of protocol therapy).
  11. Patients who are of child-bearing potential who do not agree to use birth control in accordance with institution's standard of care.
  12. Patients with a prior known history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.
  13. Patients who undergo a pelvic or para-aortic lymph node dissection prior to planned chemoradiation therapy.
  14. Patients with active infection of HIV; positive 1 / 2 antibodies.
  15. Patients with hip prosthetics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05197881


Contacts
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Contact: Steve Kohlmyer, MS 12062760076 steve.kohlmyer@varian.com
Contact: Sean Davidson, MS sean.davidson@varian.com

Locations
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United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Laronica Conway    205-975-4362    laronicaconway@uabmc.edu   
Contact: Ashley Anderson    205-975-2880    aranderson@uabmc.edu   
United States, California
Moores Cancer Center at UC San Diego Health Recruiting
La Jolla, California, United States, 92037
Contact: Nicole Daniel       mdaniel@health.ucsd.edu   
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Sarah Neufeld, MS    214-648-1836    sarah.hardee@utsouthwestern.edu   
Contact: Kevin Albuquerque, MD       kevin.albuquerque@utsouthwestern.edu   
Sponsors and Collaborators
Varian, a Siemens Healthineers Company
Investigators
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Principal Investigator: Jyoti Mayadev, MD University of California, San Diego
Principal Investigator: Xenia Ray, PhD University of California, San Diego
More Information
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Responsible Party: Varian, a Siemens Healthineers Company
ClinicalTrials.gov Identifier: NCT05197881    
Other Study ID Numbers: VAR-2021-04
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: August 3, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases