Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jyoti Mayadev, MDKevin Moore, PhD
Headshot of Jyoti Mayadev
Jyoti Mayadev
Headshot of Kevin Moore
Kevin Moore

Description

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).

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)

Keywords

Cervical Cancer by FIGO Stage 2018 Uterine Cervical Neoplasms Varian Ethos Adaptive Radiation Therapy

Eligibility

You can join if…

Open to females ages 18 years and up

  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:
  8. leukocytes ≥ 2,500/mcL
  9. absolute neutrophil count ≥ 1,500/mcL
  10. platelets ≥ 100,000/mcL
  11. hemoglobin ≥ 8 g/dL (can be transfused with red blood cells pre-study)
  12. total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
  13. AST(SGOT)/ALT(SGPT) ≤ 3 × ULN
  14. alkaline phosphatase ≤ 2.5 × ULN
  15. creatinine < 1.5 mg/dL to receive weekly cisplatin*
  16. 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).
  17. Age ≥ 18 years.
  18. No known allergy to cisplatin or compounds of similar biologic composition.
  19. . Ability to understand and the willingness to sign a written informed consent document.

You CAN'T join if...

  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

Locations

  • Moores Cancer Center at UC San Diego Health not yet accepting patients
    La Jolla California 92037 United States
  • University of Texas Southwestern accepting new patients
    Dallas Texas 75390 United States

Lead Scientists at UCSD

  • Jyoti Mayadev, MD
    Professor Of Clinical, Radiation Medicine and Applied Science, Vc-health Sciences-schools. Authored (or co-authored) 78 research publications
  • Kevin Moore, PhD
    Dr. Moore is the Deputy Director of the Medical Physics Division and Associate Director of Research. Dr. Moore is a pioneer in the nascent field of knowledge-based planning. Knowledge-based planning involves applying prior knowledge from large datasets of previously treated patients in order to optimize treatment planning of new patients, significantly improving plan quality and efficiency.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Varian, a Siemens Healthineers Company
ID
NCT05197881
Study Type
Interventional
Participants
Expecting 125 study participants
Last Updated