Evaluating the effects of radiation therapy on colorectal cancer patients with lung-limited metastases
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)
This study is testing if a special type of radiation therapy can help people with colorectal cancer that has spread to their lungs by looking at changes in their tumor DNA and genetics before and after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Naples, NAPOLI) |
| Trial ID | NCT04854213 on ClinicalTrials.gov |
What this trial studies
The PRELUDE-1 study is a pilot intervention trial focused on patients with oligometastatic colorectal cancer who have two to three lung nodules. It aims to assess the immunologic and genetic changes induced by stereotactic body radiation therapy (SBRT). Participants will undergo liquid biopsies before and after treatment to monitor tumor DNA evolution, alongside genetic assessments of their primary tumor tissues. The study will span 48 months, including 24 months for patient enrollment and up to 24 months of follow-up evaluations.
Who should consider this trial
Good fit: Ideal candidates are patients under 80 years old with a diagnosis of colorectal adenocarcinoma and two to three asymptomatic lung nodules smaller than 25 mm.
Not a fit: Patients with previous systemic anti-tumor treatments or those with significant blood count abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of how radiation therapy affects tumor genetics and immune response, potentially enhancing treatment strategies for colorectal cancer patients.
How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in understanding the effects of radiation on tumor biology.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Naples, NAPOLI
- Istituto Nazionale Tumori - Fondazione G. Pascale — Naples, Napoli, Italy (Recruiting)
Study contacts
- Principal investigator: Paolo Muto, MD — National Cancer Institute of Naples
- Study coordinator: Paolo Muto, MD
- Email: p.muto@istitutotumori.na.it
- Phone: 0815903398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.