CUPISCOTargeted Therapy vs. Chemotherapy for Cancer of Unknown Primary Site
This study aims to evaluate the effectiveness of targeted therapy compared to chemotherapy in improving progression-free survival in patients with cancer of an unknown primary site.
Alectinib
+ Vismodegib
+ Ipatasertib
Neoplasm Metastasis+3
+ Neoplasms
+ Neoplasms, Unknown Primary
Treatment Study
Summary
Study start date: July 10, 2018
Actual date on which the first participant was enrolled.This clinical trial aims to evaluate the effectiveness and safety of two different treatment approaches for patients with cancer of unknown primary site (CUP), a condition where the original tumor location is not identified. The study focuses on patients who have already received three cycles of chemotherapy containing platinum and have shown some disease control. Researchers are comparing the traditional chemotherapy method to a more personalized treatment approach, which uses genetic profiling to guide therapy decisions. This study is important because it could lead to more effective treatment strategies for patients with CUP, potentially improving their outcomes and quality of life. Participants in this study will be randomly assigned to receive either the standard platinum-based chemotherapy or a targeted therapy guided by their unique genetic profile. The targeted therapy or cancer immunotherapy is administered based on specific genetic markers found in the patient's tumor. The main goal is to measure how long the patients live without their cancer worsening, known as progression-free survival. The effectiveness of each treatment will be assessed by investigators using established criteria to evaluate tumor response. While the study aims to find a more effective treatment, participants may experience typical chemotherapy side effects or, in the case of targeted therapy, side effects specific to the drugs used. The hope is to discover whether personalized treatment provides better results compared to the traditional approach.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.529 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologically-confirmed unresectable cancer of unknown primary site (CUP) diagnosed according to criteria defined in the 2015 European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for CUP * No prior lines of systemic therapy for the treatment of CUP * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Candidate for platinum-based chemotherapy (according to the reference information for the intended chemotherapy) * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) * Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue sample \</= 4 months old that is expected to be sufficient for generation of a comprehensive genomic profile at a central reference pathology laboratory Exclusion Criteria: * Squamous cell CUP * Participants who can be assigned to a specific subset of CUP for which a specific treatment is recommended by the 2015 ESMO Clinical Practice Guidelines for CUP or with a clinical and IHC profile indicative of a specific primary tumor (favorable prognosis CUP subsets): Poorly differentiated carcinoma with midline distribution; women with papillary adenocarcinoma of the peritoneal cavity; women with adenocarcinoma involving only the axillary lymph nodes; squamous cell carcinoma of the cervical lymph nodes; poorly differentiated neuroendocrine tumors; men with blastic bone metastases and elevated prostate-specific antigen (PSA); participants with a single, small, potentially resectable tumor; colon cancer-type CUP, including participants with a CK7 negative, CK20 positive, CDX-2 positive immunohistochemistry profile; CK7-positive, CK20-negative and TTF-1 positive tumors in a context suggestive of lung adenocarcinoma or thyroid cancer; IHC profile definitely indicative of breast cancer OR an IHC profile indicative of breast cancer and either a history of breast cancer or lymph nodes in the drainage areas of the breast; high-grade serious carcinoma histology and elevated CA125 tumor marker and/or a mass in the gynecological tract or any tumor mass or lymph node in the abdominal cavity; IHC profile suggestive of renal cell carcinoma and renal lesions, with a Bosniak classification higher than IIF; IHC profile compatible with cholangiocarcinoma or pancreatobiliary (or upper gastrointestinal carcinoma) AND 1 or 2 liver lesions without extrahepatic disease or with only pulmonary metastases and/or lymph nodes in the drainage areas of the liver * Known presence of brain or spinal cord metastasis (including metastases that have been irradiated only) * Histology and immunohistology profiles (per 2015 ESMO guidelines) that are not adenocarcinoma or poorly differentiated carcinoma/adenocarcinoma * History or known presence of leptomeningeal disease * Known human immunodeficiency virus (HIV) infection * Significant cardiovascular disease * Prior allogeneic stem cell or solid organ transplantation * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or for up to 7 months after the final dose of treatment
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 125 locations
Southampton General Hospital
Southampton, United KingdomTorbay Hospital
Torquay, United KingdomBlacktown Hospital
Blacktown, Australia