Biddeford

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating the use of FDA-approved targeted therapies in patients aged 12 years and older with advanced cancer, including solid tumors, multiple myeloma, and non-Hodgkin lymphoma. The study aims to understand the safety and effectiveness of these drugs when prescribed based on specific genetic changes found in tumors. This Phase 2 trial collects real-world data from patients whose cancer has not responded to standard treatments or for whom no standard treatment is available. Participants receive one or more targeted drugs selected according to their tumor's genetic profile. Some of the drugs studied include Palbociclib, Sunitinib, Temsirolimus, Trastuzumab and Pertuzumab, Vemurafenib and Cobimetinib, Regorafenib, Olaparib, and others. Treatment plans vary based on the specific drug and tumor genetics. The study does not include all possible targeted therapies in its published details, but additional information is available through the study contacts. During the study, participants are monitored regularly to assess their cancer's response to treatment, measured by complete or partial tumor shrinkage or disease stabilization at 16 weeks. Assessments include physical and radiographic exams and genomic testing. Safety and organ function are also monitored. The study collects ongoing data from participants, including their treatment outcomes and any side effects, with results shared publicly as they become available. The trial continues to enroll patients and follow their progress over time.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

This trial studies patients with high-grade upper urinary tract urothelial carcinoma to compare the effects of adding durvalumab, an immunotherapy drug, to chemotherapy before surgery versus chemotherapy alone. The study aims to evaluate event-free survival and pathologic complete response in patients eligible or ineligible for cisplatin chemotherapy, respectively. It is a phase II/III trial that also investigates overall survival, disease-free survival, cancer-specific survival, renal function outcomes, and treatment safety. Patients eligible for cisplatin chemotherapy are randomized into two groups: one receiving durvalumab combined with accelerated methotrexate, vinblastine, doxorubicin, and cisplatin (aMVAC), and the other receiving the same chemotherapy without durvalumab. Treatments are given intravenously every 14 days for up to four cycles. Patients ineligible for cisplatin receive durvalumab with gemcitabine intravenously every 21 days for up to four cycles. Surgery to remove the affected kidney and ureter (radical nephroureterectomy) is performed within 21 to 60 days after completing systemic treatment if no metastatic or unresectable disease is detected. Participants undergo tissue biopsy, blood sample collection, and imaging with CT or MRI during the study. After treatment, they are followed up within 30 days and then every 3 to 6 months for up to 5 years. The primary outcomes measured are event-free survival for cisplatin-eligible patients and pathologic complete response at surgery for cisplatin-ineligible patients. Safety and tolerability are also monitored throughout the trial.

Researchers are evaluating whether adding stereotactic ablative radiation therapy (SABR) to standard immunotherapy improves outcomes for patients with metastatic renal cell cancer that cannot be removed by surgery. This phase II trial compares the combination of SABR and immunotherapy to immunotherapy alone. Immunotherapy drugs include monoclonal antibodies like nivolumab, ipilimumab, avelumab, pembrolizumab, and targeted therapies such as axitinib, cabozantinib, and lenvatinib. The study aims to assess kidney removal and radiographic progression-free survival as the main outcome. Participants are randomly assigned to one of two groups. One group receives immunotherapy alone, with different drug combinations given intravenously or orally as chosen by the doctor. The other group receives SABR treatment delivered in three sessions over 1 to 3 weeks alongside the same immunotherapy regimens. SABR uses high-precision radiation to target tumors with fewer doses and less damage to healthy tissue. Both groups undergo regular scans such as CT or MRI and may have bone scans and blood samples taken throughout the trial. After completing treatment, patients are followed up every six months for five years, then yearly for three more years. Researchers monitor outcomes including tumor response, disease progression, safety, side effects, survival, and biomarkers from tissue and blood samples. The study also evaluates effects on blood vessel tumors and the response of non-irradiated tumors. Total participation may last up to eight years with ongoing assessments to understand long-term benefits and risks.

Researchers are evaluating treatments for men with prostate cancer that has returned after surgery, shown by rising PSA levels. The trial tests two main questions: whether adding enhanced systemic therapy (apalutamide combined with abiraterone and prednisone) to the standard care of prostate radiation and short-term hormone therapy helps patients without cancer spread beyond the pelvis, and whether adding targeted radiation to this enhanced therapy benefits patients whose cancer has spread outside the pelvis as seen on PET imaging. This phase III study aims to see if using PET scans to guide more personalized treatment improves outcomes compared to standard care alone. Participants are divided into four groups based on PET scan results. Those without cancer outside the pelvis receive either standard radiation plus hormone therapy or the same treatment with added apalutamide. Those with cancer spread beyond the pelvis receive similar treatments but may also get targeted radiation to the metastatic sites. Treatments include various forms of radiation therapy and hormone therapies given by injection or orally. The study includes baseline PET scans, possible repeat PET scans during follow-up, and treatment lasting about six months. During the study, participants have regular assessments, including PET/CT or PET/MR imaging, blood tests, and quality-of-life questionnaires over two years and longer for some measures. Researchers track progression-free survival for up to 10 years, quality of life up to 24 months, and other outcomes like overall survival, side effects, and cognitive function. Follow-up visits occur every 3 months for two years, then less frequently up to 10 years to monitor health and treatment effects.