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Rectal Cancer clinical trials

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NCT ID: NCT01461525 Active, not recruiting - Rectal Cancer Clinical Trials

Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial

ASPIRE
Start date: October 2011
Phase: N/A
Study type: Interventional

Sphincter preservation surgery in low rectal cancer has been increased due to better understanding of tumor biology and advances in surgical technology. Furthermore, a majority of patients prefer sphincter preservation rather than living with permanent colostomy. But it is not clear whether sphincter preservation is directly related with better quality of life. There have been many studies comparing sphincter preservation surgery and abdominoperineal resection in many aspects including oncologic and functional outcomes, and the quality of life. However, the conclusion remains controversial because of the different results between studies.

NCT ID: NCT01347697 Active, not recruiting - Rectal Cancer Clinical Trials

Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer

NEAPE
Start date: September 5, 2011
Phase: N/A
Study type: Interventional

The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are: - a technique using a gluteus maximus myocutaneous flap or - a technique using an acellular porcine collagen implant (biological mesh) The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap. The study is interventional, randomized and by definition a comparative effectiveness research project.

NCT ID: NCT01257360 Active, not recruiting - Rectal Cancer Clinical Trials

Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)

NEO-RIT
Start date: December 2010
Phase: Phase 2
Study type: Interventional

The objective of this trial is to obtain evidence that, in patients with RAS wildtype tumors, a chemotherapy-free combined modality treatment with panitumumab is clearly superior to radiotherapy alone and achieves a pCR rate comparable to that after radiochemotherapy including two-drug combinations while reducing the toxicity compared to these two-drug regimens.

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: 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: 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: NCT00996710 Active, not recruiting - Breast Cancer Clinical Trials

Genomic Structural Variation in Cancer Susceptibility

Start date: October 2009
Phase:
Study type: Observational

This study will look for new types of gene changes that may be related to cancer in some patients. Some gene changes (mutations) are passed on from parents to offspring (child). Other gene changes are new and are seen for the first time in a child. They are not seen in the parent. Some of these gene changes may cause cancers in the offspring. We will look for gene changes by studying patients with cancer their parents and family members without cancer. In this study, we will be able to find gene changes that occur in the cancer patient but not in the rest of the family. Knowing the role that new gene changes play in cancer risk may help us find people at a higher risk of getting cancer.

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.

NCT ID: NCT00795301 Active, not recruiting - Rectal Cancer Clinical Trials

A Study of Radiotherapy in Rectal Cancer Using Oxaliplatin, Capecitabine With or Without Cetuximab

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

Primary Objectives To estimate the pathological complete response rate following neoadjuvant radiotherapy with concurrent capecitabine and oxaliplatin, with or without cetuximab based on the KRAS mutation status in rectal cancer. Secondary Objectives 1. To evaluate the incidence of grade 3-4 toxicities with each of the two neoadjuvant regimens and during the 30-day post-operative period. 2. To estimate the clinical tumour response rate and sphincter preservation rate with each of the two neoadjuvant regimens. 3. To correlate EGRF gene amplification with pathological response rate in those treated with cetuximab. 4. To estimate the pattern of failure. 5. To establish an annotated tissue library with samples being obtained prior to therapy and following therapy (at the time of surgery).