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Rectal Cancer clinical trials

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NCT ID: NCT05254327 Recruiting - Rectal Cancer Clinical Trials

Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001

Start date: August 15, 2022
Phase: Phase 2
Study type: Interventional

In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.

NCT ID: NCT05243771 Recruiting - Quality of Life Clinical Trials

Norwegian Stoma Trial

Start date: September 1, 2022
Phase:
Study type: Observational

The Norwegian Stoma Trial is an open-label multicenter trial investigating the use of stomas, both diveriting and permanent, in the surgical treatment of rectal cancer. The objective is to compare the chosen strategy to surgical complications, health realted quality of life and length of stay.

NCT ID: NCT05241574 Recruiting - Rectal Cancer Clinical Trials

Planned Non-operative Management for Rectal Cancer

Start date: August 3, 2021
Phase: Phase 2
Study type: Interventional

The investigators propose to conduct an observational study on consecutive patients with low-lying or mid rectal cancers smaller than 5 cm in length and less than 50% of rectal circumferential extent. The aim of this study is to test a hypothesis that escalation of either radiation or chemotherapy dose of the routine preoperative radio(chemo)therapy leads to an increase of clinical complete response rate. The planned sample size of 23 patients was calculated based on the assumption that clinical complete response rate after routine preoperative radio(chemo)therapy is 34% [1] and expected rate after radio(chemo)therapy dose escalation is 75% [2-4]. An endorectal high dose rate iridium brachytherapy boost (2 fractions of 10 Gy) will be added after the routine preoperative treatment consisted of external beam radiotherapy (5 × 5 Gy) combined with sequential 3 cycles of consolidation FOLFOX4. However, for patients with involvement of the anal canal, additional 3 cycles of consolidation FOLFOX4 (6 cycles in total) will be added instead of brachytherapy boost to avoid severe post-radiation toxicity.

NCT ID: NCT05233787 Recruiting - Rectal Cancer Clinical Trials

Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)

GRECCAR17
Start date: March 24, 2022
Phase: N/A
Study type: Interventional

GRECCAR 17 will be the first prospective and randomized trial to assess a tailored policy in the use of defunctioning stoma after TME according to the personalized risk of anastomotic leakage. The tailored use of defunctioning stoma after TME for rectal cancer should improve both the quality of life of patients and the anorectal function, without any impact on anastomotic leakage. Moreover, for the healthcare system, this new approach could be a cost-effective strategy, leading to a decrease in healthcare expenses. The main objective is to compare the impact of tailored defunctioning stoma after TME for rectal cancer versus the systematic use of defunctioning stoma on the evolution of the specific Quality Of Life (QLQC30) during the 12 months after surgery.

NCT ID: NCT05215535 Recruiting - Rectal Cancer Clinical Trials

Liver Magnetic Resonance Imaging Before Treatment for Rectal Cancer. A Randomised Controlled Trial.

Limerick
Start date: April 12, 2022
Phase: N/A
Study type: Interventional

This multicentre randomized controlled trial aims to investigate whether an abbreviated MRI is comparable to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver, in the pretreatment radiological workup in patients with rectal cancer.

NCT ID: NCT05215379 Recruiting - Rectal Cancer Clinical Trials

Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer

Start date: October 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer. Studied in this paper combin neoadjuvant chemoradiation with immune therapy, carry out "Multicenter prospective randomized clinical trial of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer" in order to provide a high-level evidence-based medical evidence for ultra-low rectal cancer treatment and improve ultra-low rectal cancer diagnosis and treatment effect.

NCT ID: NCT05201430 Recruiting - Rectal Cancer Clinical Trials

Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

RCNAC
Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.

NCT ID: NCT05176964 Recruiting - Rectal Cancer Clinical Trials

Chemotherapy and Tislelizumab With Split-course HFRT for Locally Advanced Rectal Cancer

Start date: December 31, 2021
Phase:
Study type: Observational

The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy (HFRT) treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and tislelizumab plus split-course HFRT results in better outcomes in LARC patients.

NCT ID: NCT05136326 Recruiting - Rectal Cancer Clinical Trials

Preoperative Chemoradiotherapy With CApecitabine and Temozolomide in MGMT Silenced, MSS, Locally Advanced RecTal Cancer

CATARTIC
Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

In patients with locally advanced rectal cancer (LARC), preoperative chemo-radiotherapy (CTRT) is considered the standard of care. Preoperative CTRT approach often results in a significant tumor downstaging and local control, with evidence of complete pathological response (pCR) rate of about 15% in high volume institutions. In high-risk LARC a new strategy called total neoadjuvant therapy (TNT) has emerged, in which systemic chemotherapy with fluorouracil and oxaliplatin (RAPIDO trial) or with the triplet FOLFIRINOX (as was used in the PRODIGE 23 study) is incorporated before or after the administration of short-course RT or neoadjuvant CTRT and prior to surgery. However, given the fact that TNT may represent an overtreatment for a subset of patients, additional therapeutic strategies are warranted to improve the outcomes also in patients with lower risk that are not good candidate for a TNT. In the era of personalized medicine, tumor molecular profiling may lead to the identification of therapeutic targets for pharmacological intervention potentially useful to enhance treatment outcomes. O(6)-methylguanine-DNA-methyltransferase (MGMT) repairs DNA damage induced by alkylating agents and MGMT inactivation due to promoter methylation confers enhanced sensitivity to alkylating agents such as temozolomide (TMZ). TMZ has modest activity in patients with MGMT-methylated pretreated metastatic colorectal cancer and responses are restricted to tumors with complete MGMT loss by immunohistochemistry (IHC) and microsatellite stable (MSS) status. Both capecitabine and temozolomide induces deoxythymidine triphosphate thymidine pool depletion might induce deoxyribonucleic acid (DNA)-double strand breaks and eventually apoptosis in rapidly dividing cells. On the basis of such evidences, there is a strong biological and clinical rationale for testing the addition of TMZ to capecitabine-based CTRT in patients with MGMT silenced and MSS technically resectable LARC. The aim of this trial is investigating whether the addition of TMZ to standard concurrent capecitabine-based long-course chemoradiation may increase pCR rate as compared to historical control in patients with locally advanced rectal cancer not candidate to TNT and molecularly selected for the presence of MGMT silencing and microsatellite stable status.

NCT ID: NCT05111860 Recruiting - Rectal Cancer Clinical Trials

Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy

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

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