View clinical trials related to Oligometastatic Disease.
Filter by:Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC). This is an interventional, open-label, non-randomised, single-arm phase II clinical trial. Eligible patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas must have received neoadjuvant FOLFIRINOX chemotherapy in cycles of 14 days, or other clinically indicated alternative. FOLFIRINOX is not a study treatment.
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.
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.
The goal of this phase 2 prospective clinical trial is to learn about the efficacy and safety of stereotactic body radiation therapy (SBRT) plus immunotherapy and targeted therapy in patients with unresectable or oligometastatic hepatocellular carcinoma (HCC). The main question to answer is: Whether combing SBRT with immunotherapy and targeted therapy could prolong PFS. Participants will receive SBRT to all visible lesions and concurrent systemic immunotherapy and targeted therapy.
This prospective observational study aims to investigate the effectiveness and safety of SBRT in the management of oligometastases from rare tumors. In addition, the study aims to identify potential differences in treatment efficacy and toxicity between different types of cancer and to provide valuable information on the use of SBRT in these contexts, potentially leading to better treatment options and outcomes for these patients.
This study aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment including the impact on survival, compared to continued standard first-line systemic treatment for oligometastatic colorectal cancer.
Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with NSCLC or RCC
In recent years, the scientific community has recognized the need to differentiate between poly- and oligo-metastatic disease (OMD) in oncology due to their distinct clinical and biological behavior. The definition of "true" and good-prognosis OMD is necessarily retrospective, as many patients initially considered oligo-metastatic develop poly-metastatic disease within one year. The PREDICTION study is a prospective, observational, and monocentric investigation. The study has two primary objectives. The first one is descriptive and aims to determine the prevalence of specific biological characteristics in OMD derived from gastrointestinal tract neoplasms (colon, stomach, biliary tract, exocrine glands of the digestive tract). These biological characteristics include genetic landscape and T lymphocyte infiltrate of the primary tumor and/or metastases. Genetic assessment will be done on formalin-fixed paraffin-embedded (FFPE) tissues or liquid biopsies with the Oncomine Solid Tumour DNA kit (Thermo Fisher Scientific, Waltham, MA, USA). Data analysis will be performed using the Torrent Suite Software v5.0 (Thermo Fisher Scientific). The analysis of T lymphocytes will be conducted through immunohistochemistry (IHC) in primary and or metastatic tissues (if available). The second co-primary objective aims to identify OMD through the prognostic effect of a score designed ad hoc. It is tested in a single pathology, namely in patients with metastatic colorectal cancer. A score is constructed based on the following characteristics, with possession of all characteristics (3+) constituting the full score: a primitive/metastasis genetic concordance >80% = 1 point; high T-lymphocyte infiltration GRZB+ (>10 cells/mm2) in the primary tumor and/or metastases (where tissue is available) = 1 point; absence of clonal evolution favoring specific key-driver genes = 1 point. The hypothesis is that patients with true OMD (score 3+) have a significantly lower rate of progression at one year, defined as recurrence after radical surgery or progression (in oligometastatic patients who are not candidates for upfront definitive local treatment) based on RECIST v 1.1 criteria since enrollment in the study, compared to those with false OMD who subsequently develop polymetastatic disease. The treatments will be chosen at the discretion of the referring Oncologist, in multidisciplinary sessions, according to normal clinical practice. The sample size was determined using a two-sided test of difference between proportions to evaluate the statistical significance of the difference in recurrence within 1 year. For this purpose, the following scenario was considered: a reasonable probability of the simultaneous occurrence of the 3 factors in true OMD (score 3+) of 60%; a recurrence rate of 20% for true OMD (score 3+), and 80% for false OMD (score <3+). With a significance level of α=0.05, a test power of 90%, and a Fisher exact test, the required number of patients to be enrolled is 32, to be recruited over an expected period of 2 years.
Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose. The purpose of this study is to compare single fraction (SF) SABR vs. multiple fraction (MF) SABR in regards to toxicities, progression-free survival, quality of life (QoL), and cost-effectiveness. In a subset of patients, we will also compare patient QoL, hospitalization rates, and cost-effectiveness between patients who complete QoL questionnaires, record symptoms and receive healthcare provider-guided intervention vs. patients who complete QoL questionnaires only.
This is a randomised prospective monoinstitutional study comparing radiosurgery at a total dose up to 24 Gy to five fraction stereotactic radiotherapy with simultaneous integrated boost (SIB) up to 50 Gy for the treatment of bone metastases in oligometastatic cancer treated with radical intent. At the end of the first 12 months from the start of the study an interim analysis will be performed taking into account all major endpoints for an initial evaluation of the study , with only an observational purpose, without subsequent protocol changes.