Phoenixville

Researchers are evaluating whether adding chemotherapy to immunotherapy with pembrolizumab improves overall survival compared to pembrolizumab alone in older adults with advanced non-small cell lung cancer (NSCLC) stages IIIB-IV. This phase III trial focuses on patients aged 70 and above with tumors expressing PD-L1 at 1-49% and without certain genetic mutations. The study aims to assess survival, progression-free survival, response rates, toxicity, and quality of life in this vulnerable population. Participants are randomized into two groups. One group receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. The other group receives pembrolizumab plus a chemotherapy regimen chosen by the investigator, given intravenously on specific schedules repeating every 21 days for four cycles, followed by the same pembrolizumab maintenance. Imaging with MRI, CT, and/or PET scans is performed at baseline and throughout the trial. During the trial, patients undergo regular evaluations including imaging studies, laboratory tests, and quality of life questionnaires. Follow-up visits occur every three months for up to two years after treatment and then every six months up to five years. Researchers measure overall survival, disease progression, treatment response, adverse events, and patient-reported quality of life. The study also explores safety, tolerability, geriatric assessments, and correlations between gut microbes and outcomes.

Researchers are evaluating the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the player's skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the user's performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating whether adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups: one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigator’s discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients’ health and quality of life.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points: at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are evaluating patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based therapy and are at risk of heart problems. The study includes two groups: one large observational group taking beta blockers, ACE inhibitors, or ARBs alongside trastuzumab, and a smaller randomized group comparing the effects of carvedilol versus no treatment. The aim is to understand the occurrence of heart issues and whether carvedilol might help prevent cardiac side effects from chemotherapy. Participants are assigned to one of three arms based on their current medications. Patients not on beta blockers, ARBs, or ACE inhibitors are randomized to either receive carvedilol orally twice daily or no study intervention. Those already taking these heart medications enter an observational arm without additional treatment. Treatment and observation continue for up to 108 weeks unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo heart function monitoring with echocardiograms every 12 weeks and provide blood samples for biomarker analysis. Researchers track the time to the first sign of heart dysfunction and any cardiac events, as well as adherence to medication and side effects. The study also collects data to develop models predicting heart risk and banks samples for future research. Participant involvement may last over two years with regular assessments to monitor safety and heart health.

Researchers are evaluating how well serum tumor marker directed disease monitoring (STMDDM) works compared to usual care in patients with hormone receptor positive, HER2-negative metastatic breast cancer. This trial aims to see if monitoring with serum tumor markers can provide similar overall survival outcomes to the standard approach, which involves regular imaging scans. The study also looks at healthcare costs, patient anxiety, and quality of life related to these monitoring methods. Participants are randomly assigned to one of two groups. In the usual care group, patients receive imaging studies at least every 12 weeks and may have serum tumor marker tests as determined by their doctor. In the STMDDM group, patients have blood tests for specific tumor markers every 4 to 8 weeks, and imaging scans are only done if these markers indicate a possible progression of disease. Both groups continue their monitoring for up to 312 weeks unless the disease progresses. During the study, participants undergo regular assessments including blood tests for tumor markers, imaging scans as needed, and questionnaires about anxiety and quality of life. Researchers track overall survival for up to 312 weeks and compare healthcare costs and patient-reported outcomes for up to 48 to 102 weeks. The study also collects data on how often and by what methods disease monitoring is performed, along with patient and physician preferences related to monitoring.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.