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

NCT05197881 | Recruiting FDA Device

• 1 other identifier: VAR-2021-04
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 5

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Acute Patient Reported Outcome (PRO) GI Toxicity

  GI toxicity as reported by the patient using the gastrointestinal section of the NCI-PRO questionnaire

  End of external beam treatment delivery (week 5)

Secondary Outcomes (9)

• Key powered secondary endpoint: Fecal Urgency

  End of external beam treatment delivery (week 5)

• Acute PRO Bowel Toxicity

  End of external beam treatment delivery (week 5)

• Acute PRO Urinary Toxicity

  End of external beam treatment delivery (week 5)

• Patient Reported Quality by EQ-5D-5L

  24 months post treatment

• Patient Reported Quality by EORTC

  24 months post treatment

Study Arms (1)

Daily Adaptive External Beam Radiation Therapy

EXPERIMENTAL

Daily adaptive radiation therapy delivered with Varian Ethos treatment system.

Device: Varian Ethos Adaptive Radiation Therapy

Interventions

Varian Ethos Adaptive Radiation Therapy DEVICE

Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

Daily Adaptive External Beam Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).
• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (5)

University of Alabama Birmingham

Burmingham, Alabama, 35233, United States

RECRUITING

University of Arkansas Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Moores Cancer Center at UC San Diego Health

La Jolla, California, 92037, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Study Officials

• Jyoti Mayadev, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Xenia Ray, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heike Hausen, MD

CONTACT

1-650-743-7400; heike.hausen@varian.com

Sean Davidson, MS

CONTACT

sean.davidson@varian.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 20, 2022
• Study Start: May 3, 2022
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)