Rectal Cancer Clinical Trials

The purpose of this study is to demonstrate the functionality of a novel endorectal photoacoustic ultrasound imaging modality in humans with rectal cancer. The study involves testing a previously developed endorectal device to determine its ability to accurately assess rectal tumor response to preoperative treatment. The investigators hypothesize that in vivo photoacoustic imaging will be capable of differentiating residual malignant tissue from complete response. Read Less

The iCaRe2 is a multi-institutional resource created and maintained by the Fred \& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies. Read Less

The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer. Read Less

The purpose of the study is to learn more about how the body responds to standard treatment (chemoradiation and chemotherapy). The study will use the results of testing down on participants' blook, tissue, and scans to learn more about how people with rectal cancer respond to chemoradiation and chemotherapy treatment and if it is useful for predicting whether a person's cancer get better, gets worse, or stats the same after treatment. Read Less

The purpose of this study is to test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions. Read Less

The study aims to recruit 60 Spanish speaking individuals who identify as Latinos, are 18 years or older and attend the Saint Thomas More (STM) Church in Chapel Hill. Study participants will be asked to attend an educational session at STM Church during which their baseline knowledge on colorectal cancer (CRC) and willingness to participate in cancer clinical trials (CCT) will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational videos on CRC in Spanish. After watching the videos, CRC knowledge and willingness to participate in CCTs will be reassessed. Thirty +/- 7 days after participation in the educational session, participants will be invited back at STM Church in order to complete a follow-up questionnaire assessing CRC knowledge, willingness to participate in CCTs and perceived barriers preventing Latinos from participating in CCTs. Twenty of the 60 recruited participants will be asked to participate in a qualitative one-on-one interview aimed at identifying barriers preventing Latinos from participating in CCTs. It should be noted that cancer is the leading cause of death in the United States (US) Latino community, with CRC accounting for 10% of this overall mortality. Despite this, Latinos suffer from disparities in access to care, cancer screening, treatment, and representation in CCTs. In fact, although Latino individuals are among the largest and fastest growing communities of color in the US, currently comprising 18.7%, their representation in CCTs remains low. This is of concern because: 1) advances arising from trials with limited Latino representation may not be applicable to the Latino population, and 2) decreased Latino participation in CCTs may delay Latino access to novel therapies in a timely fashion. The investigators conducting this study believe that low cancer-specific health knowledge may be impacting Latino representation and willingness to participate in CCTs and can be addressed through culturally and linguistically appropriate community-based educational interventions. Latino CCT underrepresentation is a multifaceted phenomenon and bidirectional barriers at the physician-, healthcare system-, and patient-level are significant contributors. Therefore, understanding the multiple driving forces and barriers is essential to identifying potential targets for improvement. Read Less

Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences. Read Less

The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. The researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer. Read Less

Enrolled patients will receive upfront (week 1) short-course radiotherapy to gross pelvic disease (25Gy in 5fx) in combination with AB928 (150 mg orally, once daily as part of a continuous dose regimen). This will be followed by consolidation chemotherapy (weeks 3-20) with mFOLFOX x9 cycles in combination with AB928 and AB122. Read Less

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors. Read Less

This trial (molecular characterization trial) focuses on rectal cancer, a common cancer that is treated with radiotherapy (RT) as standard of care and represents a setting in which to study the effects of RT on the immune system. Read Less

The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict. Read Less