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Recruiting Not applicable

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)

NCT04854213 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2021-10-06
Last updated
2024-11-07

Condition(s) studied

Colorectal Cancer Metastatic

Investigational drug(s) / intervention(s)

Stereotactic Body Radiation Therapy (SBRT)

Stereotactic Body Radiation Therapy (SBRT): Radiation treatment

Study 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 Cancer (omCRC) patients with two-three nodules lung-limited disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • To assess the efficacy of SBRT in inducing a regressive genetic trajectory of KRAS gene (evaluated by NGS technique) after SBRT treatment. — 40 days after the end of RT
    A genetic regressive trajectory is defined as KRAS mutated (any mutation) before SBRT and wild-type after SBRT (mutKRAS before SBRT→wtKRAS after SBRT). The sample size of the study is planned on this genetic trajectory, assuming a frequency of the phenomenon of 1/130 (as desumed from literature review). To be exhaustive, other realistic combinations are: wtKRAS→wtKRAS; mutKRAS→mutKRAS; wtKRAS→mutKRAS. Other assumptions for sample size calculation are: an alpha value of 0.05; a priori successful events rate of 0.077; 1-beta=0.60.

Trial sites (1)

FacilityCityRegionStatus
Istituto Nazionale Tumori - Fondazione G. Pascale Naples NAPOLI Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04854213 on ClinicalTrials.gov ↗ ← All trials in Italy