Active clinical trials for "Rectal Neoplasms"

An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.

AIM OF RESEARCH. The aim of our research is to improve the results of the combined treatment of patients with locally advanced rectal cancer using endovascular methods and reservoir and plastic surgery. TASKS OF RESEARCH. To assess the immediate and long-term results of combined (chemoradiation and surgical) treatment for locally advanced rectal cancer. To make a comparative evaluation of the results of independent surgical and combined (chemoradiation and surgery) treatment of patients with locally advanced rectal cancer. To examine functional results of surgical treatment with the formation of "neosphincter" and "neorectum" in patients with colorectal cancer.. To study features of blood supply to the rectum from the pools of the inferior mesenteric and internal iliac arteries, using the method of selective angiography, in connection with the development of endovascular treatment of rectal cancer. To develop and introduce into clinical practice method of one-stage selective intra-arterial oil chemoembolization of upper, middle and lower rectal arteries in patients with locally advanced rectal cancer, who have a contraindication to preoperative radiotherapy. To assess the immediate and long-term results of combined (endovascular and surgical) treatment for locally advanced rectal cancer. To optimize tactics of combined treatment of locally advanced rectal cancer by developing an algorithm of using chemoradiotherapy and endovascular interventions in the preoperative period. NOVELTY OF RESEARCH. As a result of research will be designed and implemented a new method of selective intra-arterial chemoembolization in rectal arteries preoperatively in patients with locally advanced rectal cancer. Substantiated high effectiveness of the proposed technique for the removal of colonic obstruction and, as a consequence perform radical surgical treatment of these patients. First developed dosage and concentration of chemotherapeutic agent and embolic agent for safe injection when performing selective intra-arterial chemoembolization of rectal arteries. Developed complex techniques of selective intra-arterial chemoembolization of rectal arteries preoperatively in patients with locally advanced rectal cancer. Will be made a comparative analysis of the postoperative period and the evaluation of the quality of life of operated patients Obtained data will be presented for use in clinical practice. POSSIBLE APPLICATION AREAS. Results of the research designed for use in the treatment process of departments of Coloproctology, oncology, as well as the educational process of higher and secondary medical institutions. EXPECTED EFFECTIVENESS. It is expected that the use of this method of treatment of patients with locally advanced rectal cancer in clinical practice will provide pronounced effect: Medical and social - improving the quality of care, preservation of social activity of patients, reducing mortality; Economic - reducing the time of patients' treatment and reducing the number of therapeutic manipulation; Science and Technology - improving of the training level of medicine workers in the treatment of patients with rectal cancer.

The use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is standard treatment of locally advanced rectal cancer. It has reduced local recurrence rate to less than 10%, but has only had limited effect on overall survival due to the constantly high (more than 30%) rate of distant metastasis. Complete eradication of the primary tumour observed in the histopathological specimen (pathological complete response, pCR) correlates with a favourable overall prognosis so obtaining a pCR might be beneficial. The aim of the study is to investigate whether the addition of capecitabine based chemotherapy before preoperative chemoradiation and also before the operation improves pathological complete remission rate in locally advanced rectal cancer with acceptable toxicity. Secondary objectives are to evaluate pathological downstaging rate, histopathological R0 resection rate,sphincter preservation rate, perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality of life.

This is a randomized, double-blind, placebo-controlled phase III study involving 160 patients designed to assess the efficacy of the high potency probiotic preparation VSL#3® versus placebo in increasing the pathological major response rate in patients undergoing concurrent CT and pelvic RT.

The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer

RATIONALE: Using small radiation beamlets of different intensity, IMRT (intensity modulated radiation therapy) allows shaping the dose around planning target volume with better sparing of normal tissue comparing to 3D conformal radiotherapy. It allows daily delivery of higher dose to the tumor with simultaneous integrated boost (SIB), consequently shortening total treatment time with potentially better response to treatment. In advanced rectal adenocarcinoma excellent response to preoperative radiochemotherapy with complete eradication of the primary tumor observed in the histopathological specimen (pathological complete response, pCR) correlates with a favorable overall prognosis, so trying to achieve better response to preoperative treatment with higher pCR seams feasible. PURPOSE:The hypothesis of this study is that in preoperative radiochemotherapy for locally advanced rectal adenocarcinoma shortening of the total treatment time with IMRT-SIB to 22 daily fractions concomitant with capecitabine results in an improved pCR rate from 9% (Slovenian trial) to 25%. Secondary objectives are to evaluate pathological down-staging rate, histopathological R0 resection rate, sphincter preservation rate, perioperative surgical complication rate, local control, disease-free survival (DFS), overall survival (OS), late toxicity and quality of life.

The tying at a radix of the inferior mesenteric artery (IMA) is recognized as radical cure technique in a rectal cancer surgery in Japan. In one side, the preserving the left colic artery (LCA) that is the technique to maintain blood flow of proximal sigmoid colon is performed in practice. However, there is no evidence that shows effectiveness of this technique. We conducted a randomized trial that compared between high tie and low tie of the IMA in rectal anterior resection to define an appropriate portion of IMA tying.

Radical treatment of primary rectal cancer with synchronous distant metastases includes surgical resection of primary and metastatic lesion. However, primary rectal cancer in case of metastasized disease are often locally advanced disease and need downsizing before surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside liver are 30~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and chemotherapy is used. However, the sequence of treatment modalities is not yet definitely established and preoperative chemoradiotherapy and surgical resection is accepted as an option of treatment. Conventional long course chemoradiotherapy delays administration of full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.

RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown. PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.

RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor. PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how well it works compared with straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.