Status:
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)
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Colorectal Cancer Metastatic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ...
Detailed Description
PRELUDE-1 study is a monocentric pilot interventional trial. The study concerns all patients enrolled with a diagnosis of oligometastatic Colorectal Cancer (omCRC) with two-three nodules lung-limited ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04854213
Start Date
October 6 2021
End Date
March 1 2025
Last Update
November 7 2024
Active Locations (1)
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1
Istituto Nazionale Tumori - Fondazione G. Pascale
Napoli, NAPOLI, Italy, 80131