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Oligometastatic Disease clinical trials

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NCT ID: NCT06373497 Not yet recruiting - Clinical trials for Oligometastatic Disease

Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography

Start date: September 2024
Phase: Early Phase 1
Study type: Interventional

The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to: 1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure 2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and 3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction. Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT.

NCT ID: NCT06356779 Recruiting - Surgery Clinical Trials

Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease

OLIGO-DK
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This prospective national multicenter observational and interventional study aims to assess the longitudinal disease trajectory of patients with oligometastatic disease (OMD) who receive local metastasis-directed therapy. Patients with any category of OMD from any non-hematological cancer are eligible for inclusion. Local ablative therapy (LAT) includes surgical metastasectomy, radiotherapy, thermal ablation, and electroporations. The primary objective is to assess the time to failure of LAT strategy in patients with OMD from any primary cancer treated with all LAT modalities.

NCT ID: NCT06299852 Recruiting - Clinical trials for Oligometastatic Disease

Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT. The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT. The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure.

NCT ID: NCT06212583 Recruiting - Prostate Cancer Clinical Trials

High-Risk Metachronous Oligometastatic Prostate Cancer Trial

KNIGHTS
Start date: April 17, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer.

NCT ID: NCT06207292 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Stereotactic Ablative Radiotherapy in Synchronous and Metachronous Oligo-Metastatic Non Small Cell Lung Cancer

STARTNEWERA-OM
Start date: December 2016
Phase: N/A
Study type: Interventional

This is a prospective, non-randomized, single arm, single institution phase II trial to evaluate the safety and effectiveness of stereotactic ablative radiotherapy (SABR) in oncogene addicted and non-oncogene addicted synchronous and/or metachronous oligo-metastatic (oligoM) non-small cell lung cancer (NSCLC) patients.

NCT ID: NCT06190782 Recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Local Therapy for Oligometastatic Esophageal Squamous Cell Cancer Patients Treated With PD-1 Inhibitor: a Prospective, Randomized, Phase III Clinical Trial.

Start date: September 27, 2022
Phase: Phase 3
Study type: Interventional

Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone. The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.

NCT ID: NCT06180356 Not yet recruiting - Ovarian Cancer Clinical Trials

Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

ANALLISA
Start date: August 2024
Phase: Phase 2
Study type: Interventional

The ANALLISA study is a fast, proof-of-concept, phase II clinical trial which aims to assess the efficacy of niraparib rechallenge treatment after secondary cytoreductive surgery in ovarian cancer (OC) patients with oligometastatic progression (OMP) after first maintenance therapy with any PARP inhibitor. A total of 30 patients with OC and OMP will be enrolled and will receive treatment with niraparib 300 or 200 mg, according to body weight or platelet count. Patients will start treatment within 6 weeks after surgery and will receive it until progressive disease or treatment discontinuation. The main purpose of the study is to evaluate progression-free survival (PFS) of niraparib rechallenge in OC patients with OMP and no residual disease after secondary cytoreductive surgery.

NCT ID: NCT06122480 Not yet recruiting - Clinical trials for Pancreatic Ductal Adenocarcinoma

Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

Start date: March 25, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II, Open-Label, Single Arm trial investigating the outcomes of neoadjuvant FOLFIRINOX chemotherapy in patients with hepatic or pulmonary oligometastatic pancreatic adenocarcinoma.

NCT ID: NCT06121700 Recruiting - Metastatic Cancer Clinical Trials

Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer

Miracle-G
Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of radiotherapy combined with chemotherapy and anti-PD-1 immunotherapy followed by surgery for the primary and metastatic lesions in patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies will improve the survival of this group of patients. 2) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies can be performed safely in this group of patients. Participants will receive short course hypofractionated radiotherapy (HFRT) for the primary lesion, HFRT or stereotactic body radiotherapy (SBRT) for metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For patients with HER2-positive cancer (defined as IHC 3+ or 2+/ISH+), trastuzumab is used along with chemotherapy and anti-PD-1 antibody. Then, surgical resections of primary and metastatic lesions are performed as much as possible. For patients who need a widely invasive surgical approach or are inoperable, local ablative therapies such as radiofrequency ablation (RFA) and microwave ablation (MVA) can be alternatives. For patients undergoing surgical resections, postoperative treatment includes chemotherapy, which is determined by the researcher, and PD-1 antibody, which will be maintained until one year after surgery.

NCT ID: NCT05951127 Active, not recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC

LEO
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

At present, there are relatively clear treatment guidelines for colorectal cancer with oligometastases, while the treatment mode for resectable esophageal cancer with oligometastases is not clear and there is a lack of research results in this field. The aim of this study is to provide evidence of the optimal therapy model for the local resectable esophageal cancer with oligometastases ESCC patients, by investigating whether 2-year OS of the patients could benefit from additional local consolidative esophagectomy.