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Rectal Neoplasms clinical trials

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NCT ID: NCT01237665 Active, not recruiting - Rectal Cancer Clinical Trials

IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer

IXOr
Start date: September 2010
Phase: Phase 2
Study type: Interventional

This is a prospective open label single-arm, single-institution phase II clinical trial to test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine [Xeloda], Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.

NCT ID: NCT01227239 Active, not recruiting - Rectal Carcinoma Clinical Trials

Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting

Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study. The purpose of this study is as follows, - In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD). - In phase II, to evaluate the antitumor effect (pCR rate) and the safety .

NCT ID: NCT01211210 Active, not recruiting - Rectal Cancer Clinical Trials

Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer

FOWARC
Start date: June 2010
Phase: Phase 2/Phase 3
Study type: Interventional

RATIONALE: Preoperative 5-Fu based chemoradiation has become standard treatment for stage 2/3 rectal cancer. However whether these patients, especially T3N0-1M0 patients, really need radiation for local control after total mesentery excision being applied in routine practice is still unknown. And whether new drugs adding in can achieve better local and distant control is worth investigating. PURPOSE: This randomized phase II trial is studying 5Fu based radiation therapy or FOLFOX based radiation or FOLFOX alone, comparing them to see how well they work when given before surgery in treating patients with intermediate risk resectable rectal cancer. It is not yet known whether 5-Fu based or FOLFOX based radiation therapy or even FOLFOX alone is more effective in treating rectal cancer.

NCT ID: NCT01171300 Active, not recruiting - Adenocarcinoma Clinical Trials

Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

Start date: October 2010
Phase: N/A
Study type: Interventional

Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by extensive surgery regardless of tumor response. The main question is whether extensive surgery can be avoided holding in mind that already a significant amount of patients reach a pathological complete response after radiochemotherapy. The goal of this study is dual. First of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select those patients eligible for less invasive surgery. In the same patient group, the investigators will examine the biomarker potential of molecular characteristics of the tumor in blood and tissue. Using both molecular and radiological findings, the investigators want to predict pathological response after chemoradiotherapy and to select patients who may benefit from treatment adjustments during chemoradiotherapy.

NCT ID: NCT01152164 Active, not recruiting - Rectal Cancer Clinical Trials

Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer

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

The goal of this study is gathering informations about patients' quality of life after combined modality treatment of rectal cancer to evaluate how combined modality treatment for rectal cancer affects patients' quality of life. The findings of this study may provide us important information that can be used in treatment decision and to develop programs to improve quality of life of patients with rectal cancer.

NCT ID: NCT01037049 Active, not recruiting - Neoplasms Clinical Trials

Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks

Start date: October 16, 2009
Phase: Phase 2
Study type: Interventional

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks. Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.

NCT ID: NCT00842686 Active, not recruiting - Clinical trials for Locally Advanced Rectal Cancer

Preoperative Radiotherapy With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer: CRAB Phase II Study

CRAB
Start date: January 2009
Phase: Phase 2
Study type: Interventional

The use of preoperative chemoradiation and adjuvant chemotherapy with 5-FU based chemotherapy 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. However, it has been shown that 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 bevacizumab to preoperative fluoropyrimidinebased chemoradiation 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.

NCT ID: NCT00826540 Active, not recruiting - Clinical trials for Recurrent Rectal Cancer

Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

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

This phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, 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. Sorafenib and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells

NCT ID: NCT00808379 Active, not recruiting - Rectal Cancer Clinical Trials

Concurrent Chemo-Radiotherapy Versus Radiotherapy With Boost in Locally Advanced Unresectable Rectal Cancers

Start date: May 2006
Phase: Phase 2
Study type: Interventional

At Tata Memorial Hospital 50% of the patients present in the locally advanced stage which is technically unresectable, or that is beyond the realm of a potentially curative surgical resection. The evaluation of treatment approaches for these tumors is hampered by the absence of any substantial randomized studies and the heterogeneous nature of the tumors at presentation. The management of these tumors has changed over the years, there is emphasis on neoadjuvant chemoradiation therapy, trying to convert a tumor that is initially unresectable to one that is potentially curable by surgery. But only 70-80% of the patients are able to complete this treatment without any significant treatment breaks. Dose escalated treatment with radiotherapy in locally advanced and unresectable rectal cancers have been tried in many small series with good results and lesser toxicity. Comparison outcome between the two arms will indicate the relative efficacy and toxicity of neoadjuvant concurrent chemoradiation vs boosted radiotherapy alone in downstaging of advanced cancers.

NCT ID: NCT00807911 Active, not recruiting - Rectal Cancer Clinical Trials

Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

Start date: November 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.