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Rectal Neoplasms clinical trials

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NCT ID: NCT04947020 Active, not recruiting - Rectal Cancer Clinical Trials

dataBase for Analysis of Rectal Cancer Oncological Results

BARO
Start date: August 1, 2021
Phase:
Study type: Observational

The data will be obtained from 10 tertiary centers located in Poland (Cracow - coordinating center, Warsaw - 3 centers, Sosnowiec, Szczecin, Bydgoszcz, Lublin, Gdansk, Poznan) and 5 foreign centers. The analyses will include patients with rectal cancer operated on between 2013-2019. A database in MS Excel is prepared that consists of following data: - Type of neoadjuvant treatment (if any) - Time-interval between the end of neoadjuvant treatment and surgery - Type of surgery - Staging of rectal cancer i.e. (y)pTNM - Number of retrieved lymph nodes - Number of lymph nodes with metastases - R classification (R0, R1, R2) - Preoperative medications (metformin, statins, NSAIDs, anticoagulants) - Recurrence date and type (local, systemic, both diagnosed at the same time) - Date of death or date of last follow-up visit The aims of the study are following: 1. Establishing whether neoadjuvant treatment (PSCR or chemoradiotherapy) influences number of retrieved lymph nodes in rectal cancer 2. Establishing whether time-interval between the end of PSCR and surgery influences lymph node yield 3. Establishing the prognostic value of lymph node ratio - validation of the previously calculated cutoff point at the level of 0.41 4. Determining independent prognostic factors in rectal cancer - in particular related to medications taken before the operation, metformin and anti diabetic drugs in the first place

NCT ID: NCT04942626 Active, not recruiting - Rectal Cancer Clinical Trials

Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients

ACO/ARO/AIO-21
Start date: August 20, 2021
Phase: Phase 1
Study type: Interventional

The ACO/ARO/AIO-21 investigator-driven, open-labeled, phase I drug re-purposing trial will assess whether the IL-1 receptor antagonist Anakinra can be safely combined with fluoropyrimidine-based chemoradiotherapy (CRT) in patients with rectal cancer.

NCT ID: NCT04939103 Completed - Rectal Cancer Clinical Trials

TRUS-FNA For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer

Start date: July 1, 2021
Phase:
Study type: Observational [Patient Registry]

Colorectal cancer is one of the most malignancies worldwide. The dominant clinical research strategy of LARC includes neoadjuvant chemoradiotherapy before radical surgery followed combined with adjuvant treatment. Approximately 15% to 20% of the patients after nCRT can achieve a pathologic complete response (pCR)---no residual tumor is reported at histology after a standard resection. Some researchers suggest that those patients with pCR can be spared the morbidities of surgery instead by a nonoperative approach---watch- and-wait(W&W). However, neither FDG-PET, MRI, CT, nor enteroscopy can accurately determine a pCR. EUS-FNA has been an important technique for the diagnosis of rectal cancer for its high accuracy and little harm. However, data on the TRUS-FNA for the cytologic diagnosis of pCR in rectal cancer is scarce. Our hypothesis is that adding transrectal ultrasound-guided fine needle aspiration (TRUS-FNA) compared with enteroscopy , MR, and CT alone can improve the accuracy of predicting pCR after nCRT.Therefore, the aim of the study is to assess the performance characteristics of EUS-FNA in this setting.

NCT ID: NCT04938336 Recruiting - Rectal Cancer Clinical Trials

Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

Start date: April 22, 2022
Phase:
Study type: Observational

Adapt and evaluate a decision aid for patients with rectal cancer. Phase 1 : decision aid testing (Delphi) multicentric Phase 2: pilot test decision aid

NCT ID: NCT04936581 Recruiting - Rectal Cancer Clinical Trials

Patient Reported Outcomes Following Cancer of the Rectum

PROCaRe
Start date: September 1, 2021
Phase:
Study type: Observational

The surgical management of rectal cancer includes a Total Mesorectal Excison (TME); depending on the height of the tumor, the problem of preservation of the anal sphincter arises, being able to perform a low anterior resection, an ultra-low anterior resection (RAUB) or an intersphincteric dissection. In some cases invading the sphincters or the puborectalis muscle, an abdominoperineal resection needs to be performed, being the gold standard in this particular situation so far. TME can be performed by open, laparoscopic, robotic or transanal approaches, as long as the oncological principles for the resection are achieved. Unfortunately, up to 90% of these patients will present a change in bowel habit, ranging from an increased frequency of bowel movements to the degree of fecal incontinence or evacuation dysfunction. Of these patients, 25-50% will have a severe alteration in the quality of life. This wide spectrum of symptoms has been called "low anterior resection syndrome" (LARS). Other collateral damage is the change in sexual and urinary function, due to hypogastric plexus injury. There is a significant lack of multicenter prospective studies that provide evidence, and that reveal the functional results and quality of life of these techniques available to date for the management of rectal cancer. The study is set up as a prospective multicentre observational study. Inclusion criteria are: 1) patients over 18 years old, 2) diagnosed with rectal cancer located below the peritoneal reflection, defined by preoperative MRI, 3) undergoing Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches, 4) with/without derivative stoma and 5) with/without neoadjuvant treatment. Exclusion criteria are: 1) Upper rectal cancer, located above the peritoneal reflection, 2) previous radical prostatectomy, 3) previous pelvic radiotherapy, 4) rectal resection without primary anastomosis, 5) intraoperative findings of peritoneal carcinomatosis, 6) stage IV disease, 7) multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder, 8) rectal resection due to a benign condition, 9) rectal resection due to a recurrence of rectal cancer (previous anterior resection or another primary neoplasm), 10) rectal resection following a 'watch & wait' program, 11) emergency surgery, 12) previous derivative colostomy 13) inflammatory bowel disease.

NCT ID: NCT04929028 Recruiting - HIV Infection Clinical Trials

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Start date: August 9, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, 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. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.

NCT ID: NCT04928807 Active, not recruiting - Rectal Cancer Clinical Trials

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)

Start date: July 20, 2021
Phase: Phase 3
Study type: Interventional

The study is a multicenter, open-label, randomized controlled clinical study, and the purpose of the study is to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-term radiotherapy, sequential Camrelizumab and CAPOX (group A) to long-term concurrent chemoradiotherapy, sequential CAPOX (group B) in patients with LARC. A total of 230 patients were included in this study.

NCT ID: NCT04927897 Recruiting - Rectal Cancer Clinical Trials

DETECT: Target Volume for Rectal Endoluminal Radiation Boosting

DETECT
Start date: August 16, 2022
Phase:
Study type: Observational

The aim of the study is to provide prospective data regarding microscopic tumor spread in all directions from the macroscopic tumor in pathology specimens, as seen by eye, and on imaging to define the target volume for endoluminal radiation boosting in rectal cancer patients.

NCT ID: NCT04926324 Recruiting - Rectal Neoplasms Clinical Trials

A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers

Start date: July 7, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is designed to determine the maximum tolerated dose of niraparib when combined with dostarlimab and hypofractionated radiation for locally advanced rectal cancer. Once this is determined, this dose will be tested to identify what impact it has on the tumor as well as patient reported outcome measures.

NCT ID: NCT04923620 Recruiting - Rectal Cancer Clinical Trials

Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

Start date: October 20, 2021
Phase:
Study type: Observational [Patient Registry]

Prospectively Investigate the effectiveness and safety of neoadjuvant cetuximab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS wild-type locally advanced rectal cancer