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This trial investigates monitoring and treatment options for patients with low risk and standard risk metastatic germ cell tumors, which are cancers that start in the cells that produce sperm or eggs. The study aims to find out if active surveillance after surgical removal of low risk tumors can maintain high survival rates, and whether carboplatin or cisplatin chemotherapy works better for treating standard risk tumors in children, adolescents, and young adults. Patients with low risk tumors undergo observation after surgery and may transfer to a standard risk treatment arm if the tumor recurs. Those with standard risk tumors are randomly assigned to receive one of two chemotherapy regimens one containing carboplatin, bleomycin, and etoposide, or the other containing cisplatin, bleomycin, and etoposide. Treatments are given intravenously in cycles every 21 days for up to 3 or 4 cycles depending on the group. Throughout the study, patients have imaging scans, blood tests, tumor biopsies, and pulmonary function tests to monitor response and side effects. Participants are followed closely during treatment and afterward with regular check-ups including CT, MRI, and chest X-rays, as well as blood sample collections. Follow-up visits occur every 2 months for the first year, then every 3-6 months up to 2 years, every 6 months for years 3 to 5, and annually up to 10 years. Researchers measure overall survival, event-free survival, hearing loss, body composition, tumor markers, and patient-reported outcomes related to hearing and neuropathy. This long-term monitoring helps assess the effects and safety of chemotherapy and surveillance strategies.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

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 studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating the effects of lenalidomide and dexamethasone with or without daratumumab in treating patients with high-risk smoldering multiple myeloma. This phase III trial aims to compare overall survival, progression-free survival, response rates, and safety between these treatments. The study also explores patient-reported quality of life, treatment adherence, minimal residual disease status, and imaging associations during therapy. Participants are randomly assigned to one of two treatment groups. The first group receives daratumumab intravenously on a detailed schedule across up to 24 courses, plus oral lenalidomide daily for 21 days and dexamethasone on specific days during the first 12 courses. The second group receives only oral lenalidomide and dexamethasone on a similar schedule for up to 24 courses. Treatment cycles repeat every 28 days unless disease progression or unacceptable side effects occur. During the study, participants complete quality-of-life questionnaires and undergo laboratory tests, including minimal residual disease assessments and PETCT imaging. Safety is closely monitored, especially infusion-related reactions and toxicity. After treatment, patients are followed for up to 15 years with periodic visits every 3 to 12 months to track long-term outcomes and survival.

Researchers are evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

This trial evaluates whether a shorter duration of HER2-targeted therapy is as effective as the standard length for treating early-stage HER2-positive breast cancer in patients who had a complete response after preoperative chemotherapy with trastuzumab. The study focuses on comparing 6 months versus 12 months of combined neoadjuvant and adjuvant HER2 blockade and also assesses quality of life and safety outcomes. The trial aims to determine if shorter treatment can maintain similar recurrence-free survival and reduce side effects. Participants are randomly assigned to receive trastuzumab and possibly pertuzumab either intravenously or subcutaneously every 21 days. One group receives treatment for up to 17 cycles about 12 months, while the other group receives treatment for up to 9 cycles about 6 months, as long as no disease progression or unacceptable toxicity occurs. Throughout the trial, patients undergo heart function tests echocardiography or MUGA and breast imaging mammography, ultrasound, or MRI. Optional blood and tissue samples may be collected for additional studies. Participants are followed for recurrence and survival for up to 10 years after treatment begins, with check-ins every 6 months for the first 5 years and then yearly afterward. The study measures recurrence-free survival, overall survival, local and distant cancer recurrence, and patient-reported quality of life using specific questionnaires. It also monitors serious side effects and symptoms like diarrhea, fatigue, and rash. This comprehensive follow-up helps evaluate long-term outcomes and treatment impact.

Researchers are evaluating zanubrutinib treatment approaches in older adults with mantle cell lymphoma MCL who have not received prior therapy. This phase III trial compares continuous zanubrutinib treatment versus intermittent treatment restarted upon disease progression after initial complete remission following zanubrutinib plus rituximab therapy. The study aims to find if stopping treatment and resuming later is as safe and effective as ongoing treatment, potentially reducing clinical and financial burdens for older patients. Patients begin with induction therapy receiving zanubrutinib orally twice daily and rituximab intravenously every 28 days for up to six cycles, unless disease progresses or toxicity occurs. Those achieving complete remission are randomized to either continuous zanubrutinib maintenance until progression Arm A or observation until progression followed by zanubrutinib restarted until second progression Arm B. Throughout the trial, patients may undergo bone marrow biopsies, PETCT or CT scans, and optional blood sample collections. Other procedures like endoscopies may be done as needed. Participants attend regular assessments including imaging and laboratory tests to monitor disease status and treatment effects. Researchers measure progression-free survival times, overall survival, response rates, adverse events, and quality of life outcomes with questionnaires and patient-reported symptom assessments. After study treatment ends, patients have follow-up visits every six months for up to ten years to monitor long-term outcomes and safety.

Researchers are comparing two radiation therapy approaches for men with high-risk prostate cancer to see if a shorter treatment duration can prevent cancer recurrence as effectively as the usual longer radiation schedule. This phase III trial evaluates stereotactic body radiation therapy SBRT, which delivers higher doses in five treatments over two weeks, against standard external beam radiation therapy EBRT, which involves 20 to 45 treatments over 4 to 9 weeks. The study includes men with specific high-risk features and uses advanced imaging to assess outcomes. Participants are randomly assigned to one of two groups. One group receives SBRT, involving five precise radiation treatments over two weeks, while the other group receives EBRT with 20 to 45 treatments over 4 to 9 weeks. Both groups undergo imaging tests such as bone scans, CT, MRI, or PETCT during screening and on study. Optional blood and urine samples may be collected during the trial. During the study, participants are followed every six months for up to five years to monitor metastasis-free survival, treatment effects on urinary, bowel, and sexual functions, fatigue, and overall quality of life. Various patient questionnaires and physician assessments track side effects and treatment burden. The trial also includes long-term evaluations of survival and disease progression, with imaging and laboratory tests supporting these assessments.