Princeton

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

This research aims to collect data and samples from patients who experience side effects from immunotherapy used in cancer treatment. The goal is to better understand, predict, prevent, and treat these immune-related side effects, including serious adverse events, rare infections, or accelerated tumor growth. This observational study is led by the Alliance for Clinical Trials in Oncology and focuses on patients treated with immuno-oncology therapies who have experienced significant immune-related adverse events. Participants provide tissue and blood samples, with optional stool samples for those experiencing colitis, within 72 hours of confirming a serious immune-related adverse event and again one month later. The study also includes a review of patients' medical records for up to one year. This approach helps establish a national biorepository of biospecimens and clinical data for future research. During the study, participants will undergo sample collection at two time points and have their medical history reviewed over a year. Researchers will monitor the establishment of the biorepository and collect clinical data to support future studies. This process aims to improve knowledge about immune-related side effects from immunotherapy and contribute to better patient care over time.

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.

This research aims to assess colorectal cancer rates in participants aged 45 to 70 who have 1 to 2 non-advanced adenomatous polyps. The study compares the outcomes of surveillance colonoscopy performed once at 10 years versus twice at 5 and 10 years after the initial colonoscopy. Colorectal cancer is a common and serious disease, and while colonoscopy screening reduces its incidence, the best timing for follow-up exams after finding small non-advanced adenomas is unclear. Participants are randomly assigned to one of two groups: one group receives surveillance colonoscopies at both 5 and 10 years after the qualifying colonoscopy, and the other group receives a single surveillance colonoscopy at 10 years. Colonoscopies follow standard quality guidelines and preparation instructions. All polyps found during the initial colonoscopy must have been completely removed for participants to be eligible. Throughout the study, participants will undergo colonoscopies according to their group assignment and will be monitored for the development of colorectal cancer over 10 years. Researchers will evaluate the incidence of colorectal cancer as the primary outcome. Participants' adherence to scheduled colonoscopies and any additional procedures will be tracked. This study is designed to provide clear evidence on the optimal timing of surveillance colonoscopy after detection of small adenomas, informing future guidelines and clinical practice.

Researchers are evaluating whether high-dose gabapentin can reduce the need for opioid pain medications in patients experiencing mouth sores (oral mucositis) caused by chemotherapy and radiation treatment for squamous cell carcinoma of the head and neck. Oral mucositis can cause severe pain and complications such as difficulty swallowing, weight loss, feeding tube placement, interruptions in cancer treatment, hospitalizations, and decreased quality of life. Opioids are commonly used to treat this pain but come with significant side effects and risks of long-term use. In this phase III trial, patients are randomly assigned to receive either gabapentin or a placebo starting at radiation treatment day 8. The medication is given orally once daily on day 1, twice daily on day 2, and three times daily from day 3 onward. Both groups also receive standard chemotherapy, radiation, and pain management. Treatment continues until symptoms improve and other pain medications are stopped, followed by a gradual reduction in the study drug dose. Blood samples are collected throughout the study. After treatment, patients are followed for up to 6 months. Participants will have their need for opioids monitored during chemoradiation, along with the time to first opioid use and pain scores assessed up to 4 weeks after treatment ends. Researchers will also explore opioid use duration, symptom and quality of life changes, adverse events, medication tolerance, body weight, kidney function, immune cell counts, and feeding tube requirements. Study visits include regular assessments, blood tests, and questionnaires to gather detailed information on patient outcomes and safety.

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 whether observation alone is as effective as continuing treatment with pembrolizumab in preventing cancer recurrence in patients with early-stage triple-negative breast cancer (TNBC) who achieved a complete response after receiving chemotherapy combined with pembrolizumab before surgery. This phase III trial aims to compare these approaches in terms of recurrence-free survival, quality of life, and overall value of care. The study also examines side effects, survival rates, and financial impacts associated with the treatments. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab treatment intravenously every 3 or 6 weeks for 27 weeks, while the other group undergoes observation without additional treatment during this period. Both groups will have tumor biopsies and blood samples collected, along with imaging tests like mammography, breast ultrasound, or MRI during follow-up. Throughout the study, participants will be monitored for cancer recurrence, survival, adverse events, and quality of life using questionnaires and assessments. Blood and tumor samples will help track biological markers. The primary outcome is recurrence-free survival over up to 10 years. Secondary outcomes include adverse event rates, overall survival, and local recurrence. Additional evaluations cover financial costs, work productivity, and patient-reported side effects. The total participation may involve long-term follow-up and several assessments over approximately 27 weeks and beyond.

Researchers are evaluating a phase III trial that compares a text-based smoking cessation program to a manual booklet in rural cancer survivors who smoke. The study aims to see if a personalized eight-week gradual reduction schedule combined with supportive text messages can help reduce cigarette use to zero and improve quitting success. The trial also looks at quality of life changes after quitting smoking. Participants are randomly assigned to one of two groups. The first group follows an eight-week scheduled gradual reduction program with text message support for 12 weeks. The second group receives the National Cancer Institute's Clearing the Air booklet to help plan quitting. After completing the interventions, participants are followed up for six months. During the study, participants provide urine samples and complete questionnaires on quality of life at the start, 30 days, and six months after the quit date. Researchers measure smoking cessation using biochemical validation up to six months post-quit. Quality of life scores are also tracked at these times. The trial includes assessments throughout and monitors participant progress over a total of about six months post-quit date.

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.

Researchers are evaluating the effects of olaparib treatment for one year versus two years, with or without bevacizumab, in patients who have BRCA 1/2 mutated or homologous recombination deficient (HRD) stage III or IV ovarian cancer. This phase III trial aims to compare progression-free survival and overall survival between these treatment durations, while also assessing safety and the impact of bevacizumab use. Olaparib is a PARP inhibitor that may block enzymes needed for tumor growth, and bevacizumab is an antiangiogenic agent that may slow tumor growth by stopping blood vessel formation. Participants are randomly assigned to one of two groups. In the first group, patients receive olaparib twice daily for up to two years and may also receive bevacizumab intravenously every 21 days for up to one year. In the second group, patients receive olaparib twice daily for up to one year and may also receive bevacizumab on the same schedule as the first group. Throughout the study, patients undergo blood sample collection and imaging scans such as CT or MRI to monitor their condition. After treatment, patients are followed every three months for two years, then every six months for an additional three years. During the study, participants will have their disease status assessed using imaging and blood tests, and researchers will monitor for any side effects, including serious conditions like myelodysplastic syndrome or leukemia. The main outcome measured is progression-free survival at least 360 days after treatment begins. Additional outcomes include overall survival and safety assessments up to five years. Participants' health and response to treatment will be tracked carefully throughout the study and during the follow-up period, which may last several years.