Actively Recruiting
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)
Led by National Cancer Institute, Naples · Updated on 2024-11-07
25
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age less than 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) tissue of resected primary tumor
- Negative pregnancy test for all potentially childbearing women
- Candidate for stereotactic body radiation therapy (SBRT)
You will not qualify if you...
- Previous systemic anti-tumor treatments except capecitabine or fluorouracil and radiotherapy in neoadjuvant setting completed at least 6 months before
- Neutrophils less than 2000/mm³, platelets less than 100,000/mm³, or hemoglobin less than 9 g/dl
- Serum creatinine level greater than 1.5 times the maximum normal value
- GOT and/or GPT greater than 5 times the maximum normal value and/or bilirubin greater than 3 times the maximum normal value
- Previous or current malignant neoplasms excluding certain skin cancers and in situ cervical carcinoma
- Active or uncontrolled infections
- Other uncontrolled diseases or conditions contraindicating study drugs as judged by clinician
- Presence of brain metastases
- Refusal or inability to provide informed consent
- Inability to guarantee follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituto Nazionale Tumori - Fondazione G. Pascale
Naples, NAPOLI, Italy, 80131
Actively Recruiting
Research Team
P
Paolo Muto, MD
CONTACT
A
Alessandro Ottaiano, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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