Evaluating the effects of radiation therapy on colorectal cancer patients with lung-limited metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.