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 | Recruiting

• 1 other identifier: 88/20
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer Metastatic

Keywords

SBRT; liquid biopsy; metastatic disease; cancer genetics; NGS; omCRC

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of SBRT in inducing a regressive genetic trajectory of KRAS gene (evaluated by NGS technique) after SBRT treatment.

  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.

  40 days after the end of RT

Secondary Outcomes (6)

• To evaluate the response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, version 1.1 including any eventual abscopal effect.

  Up to 24 months after the end of RT

• To evaluate the responses' duration (measured from the time of documented objective response until documented tumor progression).

  Up to 24 months after the end of RT

• To evaluate the progression-free (PFS) survival (from the data of treatment start untill progression).

  Up to 24 months after the end of RT

• The toxicity, which will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute, version 5.0, November 27, 2017.

  Up to 24 months after the end of RT

• Tumor immune microenvironment in primary tumour

  40 days after the end of RT

Study Arms (1)

Liquid biopsy

OTHER

Blood samples for liquid biopsy

Device: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) DEVICE

Radiation treatment

Liquid biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Nazionale Tumori - Fondazione G. Pascale

Napoli, NAPOLI, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paolo Muto, MD

  National Cancer Institute of Naples

  PRINCIPAL INVESTIGATOR

• Alessandro Ottaiano, MD

  National Cancer Institute of Naples

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Muto, MD

CONTACT

0815903398; p.muto@istitutotumori.na.it

Alessandro Ottaiano, MD

CONTACT

0815903510; a.ottaiano@istitutotumori.na.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 22, 2021
• Study Start: October 6, 2021
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

IT (1)