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 · NCT04854213 · Interventional (participants receive a specific treatment) · Lead sponsor: National Cancer Institute, Naples
View the official record on ClinicalTrials.gov →Interventions studied
Stereotactic Body Radiation Therapy (SBRT)
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 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
1 location listed.
- Istituto Nazionale Tumori - Fondazione G. Pascale - Naples, NAPOLI, Italy