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Anus Neoplasms clinical trials

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NCT ID: NCT04221893 Recruiting - Clinical trials for Stage IV Colorectal Cancer AJCC v8

Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

Start date: August 7, 2020
Phase: N/A
Study type: Interventional

This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.

NCT ID: NCT04166318 Recruiting - Clinical trials for Anal Canal Cloacogenic Carcinoma

Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study

Start date: January 2, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

NCT ID: NCT04157985 Recruiting - Colorectal Cancer Clinical Trials

Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors

Start date: November 15, 2019
Phase: Phase 3
Study type: Interventional

Based on the overwhelming positive response to this survey and the large number of patients being treated with PD-1/PD-L1 therapy in the UPMC system, the investigators are proposing a trial that will randomize patients who have disease stability to stop treatment at 1 year or continue treatment until disease progression. The investigators anticipate that the results of this study will answer questions regarding the optimal duration of treatment. therapy.

NCT ID: NCT04141449 Recruiting - Breast Cancer Clinical Trials

A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

Potlako+
Start date: November 18, 2020
Phase: Phase 2
Study type: Interventional

This study evaluates whether the Potlako+ intervention of community education, clinical provider support, and patient navigation can improve access to cancer case for patients presenting with symptoms of cancer. Half of communities will receive the Potlako+ intervention, while the other communities will continue to receive standard programs.

NCT ID: NCT04109573 Recruiting - Post Operative Pain Clinical Trials

Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

FLAN
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

High-grade squamous intraepithelial lesions (HSIL) and anal cancer are rising in incidence and at highest risk are HIV positive men who have sex with men (MSM). This pilot study assessing anal function and patient-reported outcomes before and after laser ablation of HSIL will add to the evidence that such a therapy is an acceptable and safe treatment to offer in a preventative setting.We will be recruting HIV positive and negative MSM.

NCT ID: NCT04094454 Recruiting - Anal Cancer Clinical Trials

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

DILANA
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of <20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of >35-49% as Grade 3 and a reduction >/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.

NCT ID: NCT04090060 Completed - Anal Cancer Clinical Trials

The Prevent Anal Cancer Palpation Study

Start date: January 17, 2020
Phase: N/A
Study type: Interventional

Anal cancer is a common cancer among men having sex with men (MSM). We will investigate increasing detection of anal canal tumors through self- or partner-palpation of the anal canal among MSM and trans persons. This study in Houston and Chicago will recruit a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged ≥ 25 years, who will be taught to perform an ASE or ACE. After performing the exam in private, the individual's ASE and partner's ACE will then be compared with a clinician's DARE. The assessment will be done at each of two visits, spaced 6-months apart. One-half of persons will be randomized to a practice condition to assess how practice affects accuracy and retention of exam procedure. Our hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits.

NCT ID: NCT04083053 Completed - Pain Clinical Trials

High-Resolution Anoscopy Perceived Discomfort Study

Start date: September 17, 2019
Phase: N/A
Study type: Interventional

Study should determine if performing the less uncomfortable part of the exam (the perianal exam) results in less recalled discomfort if performed last vs. if performed first.

NCT ID: NCT04066894 Terminated - Clinical trials for Low Anterior Resection Syndrome

Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study

Start date: April 12, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.

NCT ID: NCT04046133 Recruiting - Clinical trials for Anal Cancer Stage III B

Phase 1b/II Trial of Pembrolizumab Plus IMRT in Stage III/IV Carcinoma of Anus

CORINTH
Start date: October 19, 2020
Phase: Phase 1
Study type: Interventional

The CORINTH trial is for patients with more advanced (stage 3 and 4) anal cancer. The numbers of patients with anal cancer is increasing and only 65% patients with this later stage anal cancer have not had a recurrence 3 years after treatment. Anal cancer responds well to chemo-radiation (CRT) and this would be the treatment used for standard clinical care. The chemotherapy in CORINTH will be the same as standard of care (Mitomycin and 5FU or capecitabine) and the radiotherapy (RT) will be delivered using a technique where the dose intensity of RT can be modulated for different areas of the tumor (Intensity Modulated RT - IMRT). Translational samples (tissue blocks and blood) will be collected at baseline with further blood and tissue samples during and after treatment. Pembrolizumab, a relatively new drug, is a monoclonal antibody that enhances the body's immune response to cancer cells by acting on a receptor on the surface of T-cells called Programmed Death -1 (PD-1). The CORINTH study aims to see whether pembrolizumab, can be added safely to standard CRT. We will explore how safe the combination is and how well tolerated it is for patients with stage 3 and 4 anal cancer. If it is tolerable more patients will be treated to see if there is a similar or better clinical response. The trial is designed in 3 groups of patients. All patients will receive eight infusions of pembrolizumab at three weekly intervals. Each infusion lasts approximately 1 hour. The first group will not get pembrolizumab until they have already had 4 weeks of CRT (Day 29). As long as this is not found to cause too many extra side effects, the next group will have infusions at the beginning of the third week of CRT. The final group (cohort 3) will start their pembrolizumab with the first day of CRT i.e. Day 1. Initially each group will have 6 patients. Provided each group of patients finds the treatment tolerable and it is safe, more patients will be recruited into the group that receives the pembrolizumab earliest during their CRT. This will add further credence to the safety and tolerability of the combination and may provide a signal of how effective this treatment might be in improving outcomes for patients with more advanced anal cancer.