PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal C
PRELUDE-1 study is a pilot intervention trial that aims to describe the immunologic and genetic evolutions induced by stereotactic body radiationtherapy (SBRT) treatment in oligometastatic Colorectal Cancer (omCRC) patients with two-three nodules lung-limited disease.
| Condition(s) | Colorectal Cancer Metastatic |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | PRELUDE-1 study is a pilot intervention trial that aims to describe the immunologic and genetic evolutions induced by stereotactic body radiationtherapy (SBRT) treatment in oligometastatic Colorectal Cancer (omCRC) patients with two-three nodules lung-limited disease. |
| Who can participate | Inclusion Criteria: * Age \<80 years * Cytological or histological diagnosis of colorectal adenocarcinoma * Two or three asymptomatic lung nodules smaller than 25 mm * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Available Formalin Fixed Paraffin Embedded (FFPE) of resected primary tumor * Negative pregnancy test for all potentially childbearing women * Patient candidates to SBRT Exclusion Criteria: * Previous systemic anti-tumor treatments (allowed treatment with capecitabine or fluorouracil and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated at least 6 months before) * Neutrophils \<2000/mm³ or platelets \<100.000/mm³ or hemoglobin \<9 g/dl; serum creatinine level\> 1.5 times the maximum normal value; GOT and/or GPT \>5 times the |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | National Cancer Institute, Naples |
| Locations | Naples, NAPOLI, Italy |
| Start date | 2021-10-06 |
| NCT ID | NCT04854213 |
| Official listing | https://clinicaltrials.gov/study/NCT04854213 |