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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).
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Inclusion criteria
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
creatinine < 1.5 mg/dL to receive weekly cisplatin*
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.
Exclusion criteria
Primary purpose
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125 participants in 1 patient group
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Central trial contact
Heike Hausen, MD; Sean Davidson, MS
Data sourced from clinicaltrials.gov
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