Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix (NCT05197881) | Clinical Trial Compass
RecruitingNot Applicable
Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix
United States125 participantsStarted 2022-05-03
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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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:
Exclusion criteria
✕. 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.
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What they're measuring
1
Acute Patient Reported Outcome (PRO) GI Toxicity
Timeframe: End of external beam treatment delivery (week 5)
. 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.).