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Rectal Neoplasms clinical trials

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NCT ID: NCT03170115 Terminated - Clinical trials for Locally Advanced Malignant Neoplasm

Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer

ICAR
Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

The benefit of aspirin in cancer of the colon and rectum is already known. Recently, it was described its potential activity during chemoradiotherapy, with higher rate of tumor downstaging. Furthermore, induction chemotherapy followed by chemoradiation represents an attractive approach, with more favorable compliance and toxicity profiles. The aim of this study was to evaluate the efficacy of total neoadjuvant treatment and assess the efficacy and feasibility of aspirin use during chemoradiotherapy for high-risk rectal cancer.

NCT ID: NCT03161574 Withdrawn - Rectal Cancer Clinical Trials

FOLFOXIRI Chemotherapy Alone as Neoadjuvant Treatment for Circumferential Radial Margin (CRM) Positive Rectal Cancer

Start date: August 11, 2017
Phase: Phase 2
Study type: Interventional

Neoadjuvant 5-Fu based chemoradiation followed by surgery is a standard treatment for locally advanced rectal cancer. However, radiation-related side effects could not be neglected. But this multimodality strategy failed to improve survival. Neoadjuvant chemotherapy alone may be an alternative strategy to minimize treatment-related toxicities without compromising the oncology outcome. Thus, patients with MRI-defined CRM-positive rectal cancer will receive 6 cycles of neoadjuvant treatment with FOLFOXIRI followed by surgery. The purpose of the study is to evaluate the efficacy of FOLFOXIRI alone as neoadjuvant treatment in treating patients with locally advanced rectal cancer.

NCT ID: NCT03156036 Completed - Clinical trials for Advanced Rectal Cancer

Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC

Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

This is a prospective biomarker-stratified, randomised phase II study of preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer. The primary endpoint is pathologic complete response rates defined as total regression of the primary tumor. For each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with temozolomide plus capecitabine arms. According to the prior phase I results, MGMT hypermethylated arm is estimated as 70% of total patients and the target pathologic complete response rate was assumed as 35% in this population when treated with preoperative CRT with temozolomide and capecitabine (15% in the standard treatment arm or those with unmethylated MGMT). Investigator would like to demonstrate the superiority in terms of pathologic complete responses when treated with preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer, and to validate the predictive role of MGMT status

NCT ID: NCT03154190 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Start date: August 8, 2017
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.

NCT ID: NCT03152370 Completed - Clinical trials for Neoadjuvant Therapy in Rectal Cancer

Preoperative Radiotherapy and E7046 in Rectum Cancer

PRAER 1
Start date: May 17, 2017
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, Phase 1b study in participants with locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety, to assess the tolerability, and to determine the recommended Phase 2 dose (RP2D) of E7046 in combination with pre-operative chemoradiotherapy. The study will also assess the efficacy of the combination in the expansion part at RP2D.

NCT ID: NCT03151759 Completed - Rectal Cancer Clinical Trials

MMP-7 Modulation by Short and Long Term Radiotherapy in Rectal Cancer Patients

MMP-7
Start date: November 6, 2002
Phase: N/A
Study type: Observational

To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients.

NCT ID: NCT03149978 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis

Start date: July 1, 2014
Phase: N/A
Study type: Observational

This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer

NCT ID: NCT03144765 Active, not recruiting - Surgery Clinical Trials

Multicenter Phase II Study of Transanal TME (taTME)

Start date: January 19, 2018
Phase: N/A
Study type: Interventional

Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation treatment (CRT), complete TME with negative resection margins is associated with sustained local and systemic control even in locally advanced disease. Over the last 2 decades, laparoscopic and robotic techniques have been increasingly adopted due to reduced surgical trauma and faster patient recovery. Yet, both approaches are associated with equivalent postoperative morbidity and disturbances in sexual, urinary and defecatory function relative to open TME. Furthermore, laparoscopic and robotic TME remain associated with substantial conversion rates and variable rates of TME completeness as a result of the procedural difficulties reaching the low rectum from the abdominal approach. Transanal TME (taTME) with laparoscopic assistance was developed to facilitate completion of TME using a primary transanal endoscopic approach. Transanal TME uses a "bottom-up approach" to overcome the technical difficulties of low pelvic dissection using an abdominal approach. Published results from single-center taTME series and an international registry suggest the short-term procedural and oncologic safety of this approach in resectable rectal cancer. No multicenter phase II study has yet been conducted to validate the procedural safety, functional outcomes or long-term oncologic outcomes of this approach. Study Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic assistance in 100 eligible subjects with resectable rectal cancer. Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.

NCT ID: NCT03133286 Recruiting - Cancer Clinical Trials

Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

RADIANT
Start date: April 6, 2017
Phase:
Study type: Observational

Collect blood samples and associated clinical data prior to, during, and post radiation treatment.

NCT ID: NCT03127007 Active, not recruiting - Rectal Neoplasms Clinical Trials

Safety and Efficacy of Atezolizumab Combined to Preoperative Radio-chemotherapy in Localized Rectal Cancer

R-IMMUNE
Start date: April 27, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The study has a phase Ib and a phase II part. The phase Ib part of the study aims to determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks, concomitantly to the standard preoperative radio-chemotherapy. The phase II part of the study aims to explore efficacy of atezolizumab in combination with the standard preoperative chemo/radiotherapy in stage II and III rectal cancers.