Study to Evaluate SBRT for EGFR Mutant NSCLC Patients Receiving Osimertinib (CULTRO) (CULTRO)
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ClinicalTrials.gov Identifier: NCT05998993 |
Recruitment Status :
Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
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Condition or disease | Intervention/treatment | Phase |
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EGF-R Positive Non-Small Cell Lung Cancer Non Small Cell Lung Cancer EGFR Exon 19 Deletion EGFR Exon 21 Mutation EGFR G719X | Radiation: Stereotactic Body Radiation Therapy SBRT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study to Evaluate the Efficacy and Safety of SBRT as an Adjunctive Intervention for Oligoresidual Disease in EGFR Mutant NSCLC With First-Line Osimertinib Treatment |
Estimated Study Start Date : | November 2023 |
Estimated Primary Completion Date : | November 2026 |
Estimated Study Completion Date : | November 2028 |
Arm | Intervention/treatment |
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Experimental: Radiation
A total of 35 patients diagnosed and treated at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.
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Radiation: Stereotactic Body Radiation Therapy SBRT
This is a non-randomized Phase II study in which all patients receive the experimental treatment with Stereotactic Ablative Radiotherapy (SABR) to residual tumor lesions (up to 5 residual metastatic lesions in a maximum of 2 organs) following 12 weeks of systemic treatment with Osimertinib. The study aims to enroll 35 patients diagnosed and treated at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.
Other Name: Stereotactic radiosurgery SRS |
- Progression-Free Survival [ Time Frame: Month 12 ]Time from the initiation of systemic treatment (Osimertinib) to disease progression or death. This outcome is not influenced by second-line interventions and allows for the estimation of the relative efficacy of the treatment and its Hazard Ratio (HR)
- Overall Response Rate (ORR) [ Time Frame: Month 12 ]Proportion of patients with partial or complete response following the implementation of SBRT. This measurement does not include stable disease
- Overall Survival (OS) [ Time Frame: Month 12 ]Time from diagnosis, the first day of systemic treatment, and implementation of SBRT to death from any cause or last follow-up
- Progression-Free Time (PFT) [ Time Frame: Month 12 ]Time from the execution of SBRT to objective tumor progression, excluding death
- Adverse Events and Safety [ Time Frame: Month 12 ]Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5 from the National Cancer Institute (NCI) US
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be older than 18 years of age.
- Be capable of giving informed consent to participate in the study.
- Have histological confirmation compatible with EGFR mutant non-small cell lung cancer (NSCLC) and metastatic disease (with or without histological confirmation of metastatic lesions).
- Have confirmation of the presence of common EGFR mutations (exon 19 deletion, L858R/exon 21, or G719X) through any locally and internationally accepted standard tests.
- Have received at least 12 weeks of Osimertinib treatment (with or without the addition of chemotherapy based on FLAURA2 study results after discussion with the investigative team).
- Have a partial response defined by RECIST 1.1 criteria.
- Have a maximum of 5 residual tumor lesions in up to 2 organs suitable for treatment with Stereotactic Ablative Radiotherapy (SABR).
- Have the following imaging and clinical tests within 4 weeks before study entry:
- Contrast-enhanced brain MRI.
- Chest/abdomen/pelvis CT scan, with or without bone scan (at the investigator's discretion) if PET-CT was not performed.
- 18-FDG PET-CT.
- Spinal MRI for patients with vertebral or paravertebral metastases.
- Electrocardiogram (EKG) and transthoracic echocardiogram.
- Complete blood count and standard blood chemistry.
- Negative pregnancy test for fertile women within 4 weeks prior to starting radiotherapy.
- Liquid biopsy for assessment of tumor allelic fraction (baseline).
- ECOG performance status 0-2.
- All sites of oligoresidual disease must be safely treatable according to the following criteria:
- All brain lesions must be treatable with SRS.
- The maximum size for extracranial lesions will be up to 6 cm, with exceptions for bone metastases which may include lesions larger than 6 cm at the discretion of the investigative medical team (e.g., ribs, scapula, or pelvis).
- Life expectancy >6 months.
- Not eligible for surgical treatment.
- Osimertinib treatment must be suspended 48 hours before the start of ablative therapy and cannot be initiated within 48 hours of receiving the last fraction. In patients receiving SBRT for central lung lesions, the suspension time for Osimertinib may be extended up to 5 days before and after ablative therapy.
- Patients may have previously received treatments such as radiofrequency or microwave ablation for oligoresidual lesions, but imaging must demonstrate that the lesion persists and is treatable with SABR.
- Metastatic tumor lesions that received initial treatment with radiosurgery cannot be included for SABR treatment.
- If initial treatment was conventional radiotherapy, SABR could be considered if safe to administer. In this case, the ablative therapy must be discussed by the investigative team.
- The eligibility and prognosis criteria will be reviewed by the multidisciplinary thoracic tumor board at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.
Exclusion Criteria:
- Severe comorbidities contraindicating radiation therapy.
- Bone metastases in the femur with a high risk of fracture.
- Complete response to Osimertinib treatment (no oligoresidual disease for ablative treatment).
- Inability to treat all oligoresidual lesions with ablative intent.
- History of pneumonitis or functionally limiting interstitial lung disease. It may be considered limiting if the patient is unable to perform DLCO maneuvers or if adjusted DLCO is less than 35% of predicted, PaO2 at Bogotá altitude with FiO2 21% is less than or equal to 50 mmHg.
- Clinical or radiological evidence of symptomatic spinal cord compression.
- Dominant brain metastatic disease requiring surgical management (e.g., imminent herniation or hydrocephalus).
- Candidate for a clinical trial with an experimental drug.
- Inability to receive Osimertinib with minimal adherence.
- Oligoresidual involvement in peritoneum, pleura, or bone marrow (non-measurable disease).
- Leptomeningeal involvement (presumed based on imaging findings or confirmed by cerebrospinal fluid cytology).
- Pregnant or breastfeeding women.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05998993
Contact: Liliana Gutiérrez, RN | 3003768158 | lgutierrez@fctic.org | |
Contact: Briegel De Las Salas, Microb | 3044921963 | bcalderon@fctic.org |
Colombia | |
CTIC - Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo | |
Bogotá, Colombia | |
Contact: Liliana Gutiérrez, RN 573003768158 lgutierrez@fctic.org | |
Contact: Briegel De Las Salas, Microb 573044921963 bcalderon@fctic.org | |
Principal Investigator: Luis Rojas, MD | |
Principal Investigator: Andrés Cardona, MD | |
Principal Investigator: Iván Bobadilla, MD | |
Sub-Investigator: Jairo Zuluaga, MD | |
Sub-Investigator: Alejandro González, MD | |
Sub-Investigator: Lucía Viola, MD | |
Sub-Investigator: Stella Martínez, MD |
Principal Investigator: | Luis Rojas, MD | Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo |
Responsible Party: | Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo |
ClinicalTrials.gov Identifier: | NCT05998993 |
Other Study ID Numbers: |
CTIC001 |
First Posted: | August 21, 2023 Key Record Dates |
Last Update Posted: | August 21, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The current study is intended to be published, even if prematurely terminated. The publication may encompass all or part of the following variations: online publication of a synopsis, abstract and/or presentation at a scientific conference, or publication of a complete scientific article. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | 5 years |
Access Criteria: | Email to PI |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |