Active clinical trials for "Rectal Neoplasms"

This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced resectable rectal cancer.

This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).

The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for locally advanced rectal cancer.

Prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the Miles operation in patients with advanced rectal cancer. Primary objective: - Pathological circumferential resection margin Secondary objectives: 5 year oncological outcomes Morbimortality rates Surgical specimen quality Perineal hernia incidence

In patients with rectal cancer, an anterior resection with a colo-rectal or colo-anal anastomoses is the gold standard. However, in patients with a weak sphincter and fecal incontinence or in patients with severe co-morbidity and reduced general condition, this operation is not suitable. In these situations there are two other radical surgical options, Hartmanns procedure and the Abdominoperineal excision that can be performed with intersphincteric dissection to minimise perineal complications.There are no data on which of these procedures that are best suited for these patients with fecal incontinence or severe co-morbidity( at risk for life-threatening anastomotic leak). In this randomized study we intend to compare postoperative complications within 30 days after these two procedures and also late complications and quality of life after one year postoperatively.

With the possibility of pathological complete response in surgical specimens, some authors have proposed non-operative management of the patient group, when re-staged after neoadjuvant treatment, have complete clinical response. So far, this approach remains discussed in the literature, and there are still many uncertainties that patients with clinical complete response after chemoradiotherapy in fact no detectable viable tumor and may be omitted of radical surgical treatment. It is a still investigational approach and actually gained space even for patients with very high or who refuse surgery after all clarifications surgical risk. Hypothesis: The preservation of the rectum in patients with adenocarcinoma of the middle and distal rectum (up to 10 cm) reaching clinical complete response after neoadjuvant chemoradiotherapy have similar rate of the rectal cancer recurrence than patients who underwent surgical rectal resection. This will be a prospective, randomized, open label phase II of surgical resection versus conservative treatment (observation) in patients with mid and distal rectal cancer who achieved complete after neoadjuvant chemoradiotherapy combined with clinical response. The main objective of this study is to assess whether conservative approach is similar to rectosigmoidectomy with complete mesorectal excision or amputation abdminoperineal the rectum in patients with complete clinical response after neoadjuvant therapy combined chemoradiotherapy. Patient Selection: To be eligible patients who have neoadjuvant prior histologic diagnosis of rectal adenocarcinoma, tumors located within 10 cm from the anal verge, a complete clinical response after treatment with chemoradiotherapy for rectal tumors staged clinical and radiological T3-4 N0 M0 or T (any) N + M0, absence of colorectal synchronous tumors. Treatment: Eligible patients will be randomized 1:1 to resection of the rectum or notice. The period for randomization of patients will be 12 weeks after the last dose of radiotherapy / chemotherapy, so that we can properly assess the antitumor response as described above. After randomization, patients in the surgical group will undergo resection of the rectum with complete excision of mesorectal within 2 weeks after randomization.

Any efforts to spare patients with T1 carcinomas of the rectum from low anterior resection or even abdominoperineal resection are linked to the risk of locoregional recurrence of about 10% (range, 0-24). This is tolerated in the view of the morbidity and mortality risk related to transabdominal resection, which is as high as 7-68% and 0-6.5%, respectively. Accordingly, in addition to transanal local excision various adjuvant therapy schemes with chemo- and/or radiotherapy were developed, given the uncertainty about the lymph node stage. Another approach was to identify histological risk criteria in the primary tumor in terms of defining the limits of rectum-sparing therapy. In earlier experimental and clinical studies the investigators researched and applied dorsoposterior extraperitoneal pelviscopy, i.e. perineal access to the soft-tissue areas of the minor pelvis using minimally invasive surgery. in T1 carcinoma of the rectum this technique becomes all the more significant, as the perineal approach makes it possible to perform an endoscopic posterior mesorectal resection (EPMR) in combination with rectum-sparing surgery Thereby the relevant lymphatic field of the lower rectum can be removed and histologically examined. As a consequence EPMR should lower the loco-regional recurrence rate, since the most common causes of such are pre-existent but so far not detectable lymph node metastases besides the incomplete resection of the primary tumor.

This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. However, various "rod-less" techniques have been described and are performed with similar success. The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.

In this research study of metabolic imaging in locally advanced rectal cancer, we hope to learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy. Ultimately we hope this information will in the future help us predict which patients will benefit from more or less aggressive initial therapy for their rectal cancer.