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Rectal Cancer clinical trials

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NCT ID: NCT02012699 Recruiting - Breast Cancer Clinical Trials

Integrated Cancer Repository for Cancer Research

iCaRe2
Start date: November 1, 2013
Phase:
Study type: Observational [Patient Registry]

The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.

NCT ID: NCT01941979 Recruiting - Rectal Cancer Clinical Trials

A Study Comparing Adjuvant Chemotherapy Versus Observation for Patients With Rectal Adenocarcinoma After Neoadjuvant Chemo-Radiotherapy Treatment.

Start date: September 2011
Phase: Phase 3
Study type: Interventional

Surgery is the most indicated curative treatment for rectal cancer when disease is diagnosed early, however local recurrence risk increases when the disease is diagnosed at advanced stage.T1-2 tumors have a recurrence rate lower than 10%, while T3N0 tumors have 15% - 35% and positive lymph nodes T3-4 45% to 67% of recurrence rate within 5 years. These data indicate that patient who have a high risk of tumor recurrence should receive an adjuvant therapy treatment. It is possible that adjuvant chemotherapy has a positive impact on survival of patients already treated with neoadjuvant combination therapy. However it is necessary to identify those patients that might have this benefit. An exploratory analysis of the European Organization for Research and Treatment of Cancer (EORTC) 22921 study showed that the addition of adjuvant chemotherapy has benefited only the group of patients who had a reduction of tumor stage to ypT0-2. In the group who had no reduction (ypT3-4), there was no benefit. Retrospective analyzes suggest that the response to neoadjuvant chemoradiotherapy is a predictor of prognosis and even benefit to adjuvant chemotherapy. However the benefit of adjuvant chemotherapy for patients with rectal cancer remains controversial. Therefore, a randomized trial is needed to answer this question. Based on these data the investigators proposed a phase III study, randomized, unblinded, adjuvant chemotherapy based on Fluorouracil(5-FU) and Oxaliplatin versus observation in patients with rectal adenocarcinoma T3-4, N0-1, M0 previously treated with neoadjuvant chemoradiotherapy and who did not presented complete response. The investigator believes that this subgroup of patients, who have not achieved complete response, will be benefit from adjuvant therapy. Study objective: The main objective of this study is verify if adjuvant chemotherapy with 5-FU and oxaliplatin, for 4 months, increases recurrence-free survival versus the observation. Secondary objectives include the evaluation of toxicity, overall survival and assessment of biomarkers (study protocol separately). The study's primary endpoint is disease-free survival (DFS) to be defined as time from randomization to radiological detection of distant disease and / or locoregional recurrence. Isolate carcinoembryonic antigen (CEA) increase will not be consider as recurrence until a new measurable lesion be found. NOTE: The TNM system is based on the size and/or extent (reach) of the primary tumor (T), the amount of spread to nearby lymph nodes (N), and the presence of metastasis (M) or secondary tumors formed by the spread of cancer cells to other parts of the body.

NCT ID: NCT01923987 Recruiting - Rectal Cancer Clinical Trials

Short Course Radiotherapy Followed Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis

Start date: August 2012
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT01865071 Recruiting - Rectal Cancer Clinical Trials

Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Start date: September 2011
Phase: N/A
Study type: Interventional

Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

NCT ID: NCT01863862 Recruiting - Rectal Cancer Clinical Trials

Organ Preservation in Elderly Patients With Rectal Cancer

Start date: August 2012
Phase: N/A
Study type: Interventional

In elderly patients postoperative mortality measured 3-6 months after total mesorectal excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly patients even if a risk of local recurrence is slightly higher compared to the open surgery. The investigators addressed the question whether watch and wait policy is safe in clinical complete responders after (chemo)radiation for elderly patients with small or moderately advanced tumours.

NCT ID: NCT01818973 Recruiting - Rectal Cancer Clinical Trials

Preoporative Bevacizumab, Radiation Therapy, and XELOX Chemotherapy for Locally Advanced Nonmetastatic Rectal Cancer

Start date: March 2013
Phase: Phase 2
Study type: Interventional

We presumed that the addition of a monoclonal antibody Bevacizumab into radiation therapy and combination chemotherapy could results in improved pathologic tumor regression grade (TRG) in locally advanced nonmetastatic rectal cancer.

NCT ID: NCT01814969 Recruiting - Rectal Cancer Clinical Trials

Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer.

Start date: March 2014
Phase: Phase 3
Study type: Interventional

Clinical objective of the study is to compare the rates of pathologic response, acute toxicity and sphincter preservation with two schedules of preoperative regiment in patients with locally advanced rectal cancer.

NCT ID: NCT01797770 Recruiting - Rectal Cancer Clinical Trials

Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery

MBP
Start date: January 2012
Phase: Phase 4
Study type: Observational

This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery. In this trial patients with left sided colon and rectal tumors were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome

NCT ID: NCT01745874 Recruiting - Rectal Cancer Clinical Trials

Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging

Start date: October 2012
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer.

NCT ID: NCT01716949 Recruiting - Rectal Cancer Clinical Trials

Neoadjuvant Chemoradiation With 5-FU(or Capecitabine) and Oxaliplatin Combined With Hyperthermia in Rectal Cancer

HyRec
Start date: September 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This trial examines the feasibility, effectiveness and safety of a combination of radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally advanced or locally recurrent rectal cancer. Previous pelvic irradiation in case of a local recurrence is not excluded from the trial. The treatment protocol aims on a preoperatively improved tumor regression allowing less aggressive surgery in primary locally advanced rectal cancer and a higher rate of curative resections in heavily pretreated locally recurrent rectal cancers. Primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of radiochemotherapy and hyperthermia. Secondary endpoints are local control, survival rates, and toxicity. It is planned to include a total number of 59 patients over a period of 2.5 years.