Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama Birmingham
Birmingham, Alabama 35233
Contact:
Laronica Conway
205-975-4362
laronicaconway@uabmc.edu

More Details

Status
Recruiting
Sponsor
Varian, a Siemens Healthineers Company

Study Contact

Steve Kohlmyer, MS
12628805099
steve.kohlmyer@varian.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.