Daily Adaptive External Beam Radiation Therapy in the Treatment of Carcinoma of the Cervix: A Prospective Trial of an Individualized Approach for Intestinal Toxicity Reduction (ARTIA-Cervix)
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).
• 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\*
∙ 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).
• 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.