PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients with LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells)
Recruiting now · Not applicable
Conditions studied: Colorectal Cancer Metastatic
In brief
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.
Key facts
- Study ID
- NCT04854213
- Run by
- National Cancer Institute, Naples
- People needed
- 25
- Starts
- 2021-10-06
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2024-11-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 maximum normal value and/or bilirubin level >3 times the maximum normal value
- Previous or concomitant malignant neoplasms (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix)
- Active or uncontrolled infections
- Other concomitant uncontrolled diseases or conditions contraindicating the study drugs at clinician evaluation
- Presence of brain metastases
- Refusal or inability to provide informed consent
- Impossibility to guarantee follow-up
Where it is running
- Istituto Nazionale Tumori - Fondazione G. Pascale — Naples, NAPOLI, Italy (enrolling)
Full record on ClinicalTrials.gov
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