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Rectal Neoplasms clinical trials

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NCT ID: NCT03875781 Recruiting - Rectal Cancer Clinical Trials

Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer

NORAD01
Start date: June 5, 2019
Phase: Phase 3
Study type: Interventional

This study is a non-inferiority phase III randomised trial comparing preoperative chemotherapy alone (modified FOLFIRINOX) to chemotherapy followed by chemoradiotherapy in patients with primary resectable locally advanced rectal cancer. The primary endpoint of the study is 3-year progression free survival. Expected 3 year PFS rate in the preoperative chemotherapy followed by chemoradiotherapy arm is 75%. This hazard rate, in an exponential survival model, corresponds to a decrease in the 3-year PFS rate on the preoperative chemotherapy arm to 67%. The study will randomize 540 patients (270 in the chemotherapy group and 270 in the chemoradiotherapy group) in 42 french academic centers.

NCT ID: NCT03874559 Recruiting - Rectal Cancer Clinical Trials

Exosomes in Rectal Cancer

Start date: February 13, 2018
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT03846882 Recruiting - Rectal Cancer Clinical Trials

FDG - PET / MRI in Patients With Rectal Cancer

RECTOPET
Start date: December 1, 2015
Phase:
Study type: Observational

The combination of FDG-PET/CT and MRI at staging of rectal cancer in diagnosis is currently very little studied. The investigator have a unique opportunity to study this. Hypothetically, with PET/MR as one hybrid imaging method, alternatively as an additional method, it could increase the accuracy of rectal cancer of moderate and high risk type, especially at primary N-staging, but also in assessing other important prognostic factors such as T-staging, peritoneal involvement, metastasis to lateral lymph nodes, EMVI and MRF involvement. The same reasoning applies to the assessment of tumor regression after CRT. In the study, PET/MR is compared with PET/CT, diagnostic CT and MRI to evaluate the additional value of the hybrid imaging PET/MRI. The investigator also plan to evaluate how immunological, proliferative and prognostic biomarkers in blood and tumor tissue correlate with the radiological findings, and if the combination biomarker and radiology can provide additional prognostic information.

NCT ID: NCT03826862 Recruiting - Rectal Cancer Clinical Trials

Lateral Lymph Node Dissection for Middle-low Rectal Cancer

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

The investigators will perform CT three-dimension reconstruction for middle-low rectal cancer patients who have enlarged lateral lymph nodes to recognize the variance of pelvic vessels, by which to help reduce operative time and blood loss, localize the lateral lymph nodes, improve the lymph node harvested and positive rate. Besides, The investigators will label the vessels near the interested node to achieve node-by-node for further investigation.

NCT ID: NCT03824899 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer

Start date: October 10, 2018
Phase: N/A
Study type: Interventional

The study evaluates the associations between peak and valley concentrations of SN-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6 /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end point are toxicity and pCR rate.

NCT ID: NCT03731130 Recruiting - Quality of Life Clinical Trials

Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

NEOCARE
Start date: October 5, 2018
Phase:
Study type: Observational

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional Outcome, oncological outcome and toxicity in patients treated with neoadjuvant short term radiation or long-term chemoradiation followed by surgery

NCT ID: NCT03718351 Recruiting - Early Rectal Cancer Clinical Trials

Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.

Start date: September 24, 2018
Phase: N/A
Study type: Interventional

Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Particularly, However, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. Colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. Endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. In the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.

NCT ID: NCT03714490 Recruiting - Rectal Neoplasms Clinical Trials

MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer

SUNRISE
Start date: October 23, 2018
Phase: Phase 2
Study type: Interventional

Improvements in downstaging are required when using preoperative chemoradiation for unresectable rectal cancer. There is therefore a need to explore more effective schedules. The study arm will receive MRI simulation-guided boost in short-course preoperative radiotherapy followed by consolidation chemotherapy , which may enhance the shrinkage of tumor comparing with the concurrent chemoradiation.

NCT ID: NCT03702985 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

Start date: May 28, 2018
Phase: Phase 2
Study type: Interventional

The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. Then it will depends which regimens the patient would receive according to his or her pathological results.

NCT ID: NCT03699761 Recruiting - Rectum Cancer Clinical Trials

The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.