University of Cincinnati Cancer Center-West Chester

Researchers are evaluating a text-based program designed to help rural cancer survivors who smoke to quit smoking. This phase III trial compares an eight-week scheduled gradual reduction SGR intervention delivered via personalized text messages combined with the National Cancer Institutes Smokefree.TXT service to a control group receiving a smoking cessation booklet. The study aims to assess how effective these approaches are in achieving biochemically validated smoking cessation six months after quitting, as well as their impact on quality of life. Participants are randomly assigned to one of two groups. The first group follows a personalized eight-week gradual reduction schedule, supported by cessation messages sent by text for 12 weeks. The second group receives the NCI Clearing the Air booklet to assist in planning gradual smoking cessation. After completing the interventions, participants are followed for a total of six months post-quit date to evaluate outcomes. During the study, participants will provide urine samples and complete questionnaires to measure smoking status and quality of life at baseline, 30 days, and six months after quitting. The research team uses biochemical validation to confirm smoking cessation. Participants must have texting capability on a cell phone or smartphone and be able to read and speak English. The total participation includes the intervention period plus follow-up to monitor smoking cessation and quality of life changes.

Researchers are investigating treatments for men with prostate cancer that has returned after surgery, focusing on those who experience a rise in prostate-specific antigen PSA levels, indicating biochemical recurrence. The study examines whether adding enhanced systemic therapy apalutamide combined with abiraterone and prednisone to standard care, which includes prostate radiation therapy and short-term androgen deprivation, improves outcomes. Additionally, for patients whose cancer has spread beyond the pelvis as detected by PET imaging, the study evaluates the benefit of adding metastasis-directed radiation therapy. Participants undergo baseline PETCT or PETMR scans to determine the extent of cancer spread. Based on these results, they are randomized into one of four treatment arms standard radiation with androgen deprivation, enhanced therapy including apalutamide, or enhanced therapy plus targeted radiation for metastatic disease. Treatments involve various forms of radiation therapy, androgen deprivation drugs, and oral apalutamide, administered over six months in the absence of disease progression or unacceptable side effects. Some patients may receive repeat PET scans to assess treatment response. During the study, participants have scheduled assessments including imaging, blood tests measuring PSA levels, and quality-of-life questionnaires over up to ten years. Follow-up visits occur every three months for the first two years, then less frequently up to ten years. Researchers monitor progression-free survival, overall survival, event-free survival, PSA progression, adverse events, and quality of life measures including cognitive function and fatigue. This long-term monitoring aims to determine the effectiveness of the added therapies compared to standard treatment alone.

This trial studies patients with relapsed or refractory T-cell acute lymphoblastic leukemia T-ALL or T-cell lymphoblastic lymphoma T-LBL. It evaluates the safety, side effects, best dose, and effectiveness of OBI-3424, a chemotherapy drug designed to stop cancer cell growth by killing cells or preventing their division or spread. The study also explores how OBI-3424 affects disease remission and survival outcomes. Patients receive OBI-3424 intravenously over 30 minutes on days 1 and 8 of each 21-day cycle. Treatment can continue for up to 17 cycles if the disease does not progress and side effects remain acceptable. Those who do not show partial remission by the fourth cycle may be removed unless the investigator finds them clinically benefiting. The study includes blood tests, cerebrospinal fluid collection, bone marrow biopsy, and possible CT scans throughout treatment. Participants undergo screening with blood tests and provide samples during treatment. They are monitored regularly with bone marrow samples and imaging to assess disease status and treatment response. Follow-up visits occur monthly for one year, then every two months for another year, every three months for a third year, and every six months for up to five years from registration. Researchers measure the maximum tolerated dose, response rates, side effects, survival, and minimal residual disease among other outcomes.

Researchers are studying colorectal cancer CRC in participants aged 45 to 70 who have 1 to 2 non-advanced adenomas, which are small colon polyps without high-risk features. The trial compares two surveillance colonoscopy schedules one group receives colonoscopy at 5 and 10 years after polyp detection, while the other group has colonoscopy only at 10 years. This study aims to provide randomized data to guide optimal timing for follow-up colonoscopies to help reduce CRC incidence and improve clinical practices. Participants are randomly assigned to one of two groups the first group undergoes surveillance colonoscopy at both 5 and 10 years following their qualifying colonoscopy, and the second group undergoes colonoscopy at 10 years only. All colonoscopies, including any unscheduled ones, follow current quality guidelines and institutional preparation standards. The qualifying colonoscopy must have been complete and performed within 4 years before randomization, with all polyps fully removed. During the study, participants will undergo colonoscopies according to their assigned schedules. Researchers will monitor the incidence of colorectal cancer over 10 years as the primary outcome. Participants must be able to understand English or Spanish to complete required procedures. The study may last up to several decades, with ongoing monitoring to assess long-term cancer incidence and the effectiveness of different surveillance intervals.

Researchers are evaluating dose-escalated radiation therapy compared to usual care for patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have already completed 4 to 6 months of chemotherapy. The study is a phase III trial aiming to determine if higher doses of radiation can improve 3-year overall survival, as well as assess effects on tumor progression, chemotherapy-free intervals, treatment toxicity, and quality of life. This trial is led by NRG Oncology and focuses on patients without disease progression after initial chemotherapy. Participants are randomly assigned to one of two groups. The first group receives standard care, which may include additional chemotherapy options such as FOLFIRINOX, NALIRIFOX, or gemcitabinenab-paclitaxel, standard radiation therapy with concurrent chemotherapy, or observation. The second group receives dose-escalated radiation therapy delivered in either 5 or 25 fractions, with or without concurrent chemotherapy for the 25-fraction option. After radiation, patients who have not completed 6 months of chemotherapy are encouraged to finish it, with treatment beyond 6 months at the physicians discretion. Imaging and tissue biopsies are performed throughout the study. Participants undergo various assessments including blood sample collection, CT scans, MRI, and optional PETCT scans before and during treatment. Tumor tissue biopsies are also collected. Follow-up visits occur every 3 months for the first 2 years and annually for an additional 3 years. Researchers measure overall survival, local disease progression, progression-free survival, chemotherapy-free intervals, and adverse events. Quality of life is evaluated using specific questionnaires over the course of participation.

Researchers are evaluating how well venetoclax works in treating patients with relapsed hairy cell leukemia or its variant. This phase II trial focuses on patients whose disease has returned after previous improvement and aims to measure the response rates, including complete remission and minimal residual disease-negative status. The study also explores how genetic mutations may relate to treatment response and evaluates the safety of venetoclax in this patient group. Participants receive venetoclax by mouth once daily on days 1 through 28 of each 28-day cycle. Treatment may continue for up to 19 cycles unless the disease progresses or unacceptable side effects occur. During the study, patients undergo imaging scans like CT or MRI and blood tests regularly. Bone marrow biopsies or aspirations may also be performed, and those with central nervous system involvement may have lumbar punctures throughout the trial. Participants are monitored closely with various tests including blood samples, imaging, and possibly bone marrow and cerebrospinal fluid assessments. After finishing treatment, patients have a follow-up visit at 30 days to assess outcomes. Researchers measure the objective response rate up to 30 days after the last dose, along with remission rates, minimal residual disease status, duration of response, and safety events over this period.

This trial investigates the addition of panitumumab to standard chemotherapy for patients with KRAS wild type pancreatic ductal adenocarcinoma that cannot be removed by surgery or has spread locally or to other parts of the body. The study aims to compare overall survival and other clinical outcomes between patients receiving panitumumab plus chemotherapy and those receiving chemotherapy alone. It also evaluates quality of life, treatment toxicity, and patient-reported symptoms. Participants are randomly assigned to one of two groups. One group receives panitumumab intravenously on days 1 and 15, combined with one of several chemotherapy regimens given intravenously in 28-day cycles, repeating if tolerated without disease progression. The other group receives the same chemotherapy regimens without panitumumab, also in 28-day cycles. Throughout the study, patients undergo CT scans and blood sample collection. After treatment, they are followed for up to three years. During the study, participants will have regular imaging and blood tests to monitor disease status and treatment effects. Quality of life and symptom questionnaires are completed at specified intervals. Researchers measure overall survival, progression-free survival, response rates, duration of response, and treatment side effects. Safety is monitored up to 30 days after treatment ends. Specimens are banked for future research, and patient-reported outcomes help assess the impact of treatment over 24 weeks.

Researchers are evaluating the combination of durvalumab, gemcitabine, and cisplatin given before surgery to treat patients with high-risk liver cancer called resectable intrahepatic cholangiocarcinoma. This phase II study aims to see how well patients complete this pre-surgery therapy and proceed to surgical removal of the tumor. The study also investigates tumor response, survival rates, and the safety and feasibility of the treatment approach. Participants receive durvalumab intravenously on day 1, with gemcitabine and cisplatin given intravenously on days 1 and 8, repeated every 21 days for 4 cycles before surgery. After surgery, patients may continue the same regimen for up to 4 more cycles if disease progression or unacceptable side effects do not occur. During the study, patients undergo CT and MRI scans, blood sample collection, and tissue biopsies at screening and during treatment. Throughout the study, participants are closely monitored with imaging and laboratory tests to evaluate tumor response and detect side effects. After completing treatment, patients have follow-up visits every 3 months for 2 years, then every 6 months for 5 years, and yearly afterward to assess survival and cancer recurrence. The main outcome measured is the proportion of patients who complete the pre-surgery therapy and surgery, with additional measures including pathological response, margin status after surgery, radiological response, overall and relapse-free survival, and adverse events.

Researchers are evaluating treatments for people with skin squamous cell carcinoma that has returned or spread, focusing on those with weakened immune systems. This phase II trial compares amivantamab combined with hyaluronidase to cetuximab, both monoclonal antibodies, to see how they affect disease progression and safety. The study seeks to understand if amivantamab with hyaluronidase is as effective as cetuximab in controlling locally recurrent or metastatic disease in immunocompromised patients. Participants receive either amivantamab and hyaluronidase injected under the skin on specific days during 28-day cycles or cetuximab given intravenously on days 1 and 15 of each cycle. Treatment may continue for up to 24 cycles, provided the disease does not worsen and side effects remain acceptable. Throughout the study, patients undergo blood sample collections and imaging scans like CT or MRI to monitor their disease. Participants are involved in regular assessments including physical exams and tumor evaluations by CT or MRI. Researchers measure treatment safety by tracking toxicities in the first treatment cycle and evaluate progression-free survival over up to three years. Secondary outcomes include overall survival, time to next treatment, and response duration, with follow-up extending up to five years. Specimens may also be collected for future research. Total participation can last several years, including treatment and follow-up periods.

Researchers are evaluating the addition of BMX-001 to usual symptom management compared to usual symptom management alone to reduce oral mucositis in patients receiving chemoradiation for head and neck cancer. Oral mucositis, which causes inflammation and mouth sores, is a common side effect of chemoradiation that can lead to pain and difficulty swallowing. This phase II trial aims to compare the incidence and duration of severe oral mucositis, as well as other side effects like xerostomia and radiation dermatitis, between the two treatment groups. Participants are randomly assigned to one of two groups. Both receive cisplatin chemotherapy once weekly or every three weeks and undergo image-guided intensity-modulated radiation therapy daily for seven weeks. In addition to usual symptom management, one group receives placebo injections subcutaneously twice a week for eight weeks, while the other group receives BMX-001 injections on the same schedule. Imaging such as CT and MRI scans and optional blood, serum, or plasma collection occur during the study. Throughout the trial, participants complete questionnaires and are monitored for side effects, toxicities, and oral mucositis severity up to 24 months after completing treatment. Follow-up visits occur at 1, 2, 3, 6, 12, and 24 months. Researchers assess patient-reported symptoms, duration of oral mucositis, radiation dermatitis, and overall survival outcomes. The trial also collects biological samples for future research.