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Rectal Neoplasms clinical trials

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NCT ID: NCT01023529 Completed - Prostatic Neoplasms Clinical Trials

Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers

PallRad1
Start date: November 2009
Phase: N/A
Study type: Observational

The purpose of this study is to assess the effect of palliative pelvic radiation on symptoms and quality of life among patients with incurable prostate and rectal cancer.

NCT ID: NCT01013805 Completed - Rectal Cancer Clinical Trials

Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

PROArCT
Start date: November 2009
Phase: Phase 2
Study type: Interventional

The aims of the trial are (1) to determine the tolerability rate in the setting of a multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and complete pathologic response rate in patients with locally advanced rectal cancer who are treated with an integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.

NCT ID: NCT00988936 Completed - Clinical trials for Metastatic Breast Cancer

Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug

K5-101
Start date: September 2009
Phase: Phase 2
Study type: Interventional

A Pilot Phase II Study The primary objective for this study is: - To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed The secondary objectives for this study are: - To continue safety evaluation by collection of safety data from all patients - To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy study Duration: Screening visit (3-4 hrs), pre-treatment imaging visit of [F-18]RGD-K5 PET/CT (~ 3-4 hrs) and the standard [F-18]FDG PET/CT (~ 3-4 hrs) or diagnostic CT, followed by two [F-18]RGD-K5 PET/CT scans, one after the second but before the third Avastin® treatment, and one after the fourth but before the fifth Avastin® treatment, and a follow up standard [F-18]FDG PET (~ 3-4 hrs) or diagnostic CT. Procedures: Informed consent, collection of demographic information, medical history, blood labs, physical examination, vital signs, ECGs, three sets of [F-18]RGD-K5 dosing and imaging scans including pretreatment, early mid-treatment, and later mid-treatment, concomitant medication collection, adverse event monitoring, and assessment of tumor response to treatment Patients: Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer who will receive chemotherapy plus Avastin®. This allows for approximately 30 evaluable patients to complete this study at approximately four to eight sites internationally

NCT ID: NCT00979680 Completed - Rectal Cancer Clinical Trials

Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma

GRECCAR1
Start date: April 2001
Phase: Phase 3
Study type: Interventional

This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.

NCT ID: NCT00972881 Completed - Rectal Cancer Clinical Trials

Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

EXCITE
Start date: April 2009
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy, cetuximab, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I/II trial is studying the side effects of giving capecitabine and irinotecan hydrochloride together with cetuximab and radiation therapy and to see how well it works in treating patients undergoing surgery for locally advanced rectal cancer.

NCT ID: NCT00969657 Completed - Rectal Cancer Clinical Trials

Validation of a Predictive Model After Complete Response in Rectal Cancer

Thunder
Start date: August 2009
Phase: N/A
Study type: Observational

Background of the study: Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in individualizing treatment strategies, i.e., selecting patients who need less invasive surgery or another radiotherapy strategy instead of resection. For rectal cancer it is known that 10-30% of the patients will respond with a pathologic complete response (pCR) after CRT. From a retrospective study with multivariate analysis of both clinical and 2-[18F] fluoro-2-deoxy-D-glucose and positron emission tomography (FDG-PET) data, it was found that adding FDG-PET data collected before and after CRT leads to a more predictive model compared to evaluating only pretreatment clinical data. To validate this model, this registration study is proposed. Furthermore, it has been found that FDG-PET during treatment is very predictive for response and a more favorable time point to adapt treatment. Also, there are indications that adding blood biomarkers to the data, results in higher accuracy for response prediction compared to clinical and imaging data alone. Therefore, FDG-PET during treatment and blood sampling are included in the protocol to improve the accuracy of the prediction models. Objective of the study: The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient. Study design: 28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1 PET-CT scan Before radiotherapy, on day 15 and 8 weeks after radiotherapy: blood sample taken.

NCT ID: NCT00963794 Completed - Rectal Cancer Clinical Trials

Diagnosis of Rectal Cancer by Electromagnetic Device

Start date: January 2008
Phase: N/A
Study type: Interventional

The aim of the present prospective study was to evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was attributed to subjects showing an electromagnetic signal < 50 units (U).

NCT ID: NCT00956241 Completed - Rectal Cancer Clinical Trials

J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer

Start date: April 2002
Phase: N/A
Study type: Interventional

The objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.

NCT ID: NCT00952926 Completed - Rectal Cancer Clinical Trials

Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy

Start date: October 2009
Phase:
Study type: Observational

The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.

NCT ID: NCT00942266 Completed - Clinical trials for Recurrent Rectal Cancer

Vorinostat, Fluorouracil, and Leucovorin Calcium in Treating Patients With Metastatic Colorectal Cancer That Has Not Responded to Previous Treatment

Start date: July 2009
Phase: Phase 2
Study type: Interventional

RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which dose of vorinostat is more effective when given together with combination chemotherapy in treating patients with metastatic colorectal cancer. PURPOSE: This randomized phase II trial is studying the best dose of vorinostat to see how well it works when given together with fluorouracil and leucovorin calcium in treating patients with metastatic colorectal cancer that has not responded to previous treatment.