Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the 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 thera
| Condition(s) | Cervical Cancer by FIGO Stage 2018 |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 involved paraaortic lymph nodes. 2. 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). 3. Patients must NOT have had a hysterectomy. 4. 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. 5. Patients must be planning to undergo concurrent pelvic radiat |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Varian, a Siemens Healthineers Company |
| Locations | Burmingham, Alabama, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; Philadelphia, Pennsylvania, United States; Dallas, Texas, United States |
| Start date | 2022-05-03 |
| NCT ID | NCT05197881 |
| Official listing | https://clinicaltrials.gov/study/NCT05197881 |