NCT04854213Recruiting
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)
Source: ClinicalTrials.gov · Last updated 7 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 9 Apr 2021
- Start date
- 6 Oct 2021
- Primary completion date
- Jan 2025
- Lead sponsor
- National Cancer Institute, Naples
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT04854213
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 6 Oct 2021 to the primary completion date, Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Previous or concomitant malignant neoplasms (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix)
- Other concomitant uncontrolled diseases or conditions contraindicating the study drugs at clinician evaluation
Other illness
- Active or uncontrolled infections
Lab values
- 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
Other
- Presence of brain metastases
- Refusal or inability to provide informed consent
- Impossibility to guarantee follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Nazionale Tumori Fondazione G. Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.