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Rectal Neoplasms clinical trials

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NCT ID: NCT02538913 Terminated - Rectal Neoplasms Clinical Trials

Exercise Training for Rectal Cancer Patients

Start date: September 2015
Phase: N/A
Study type: Interventional

Cancer treatments often cause acute toxicity during treatment, and late toxicity after treatments have ended. Bowel dysfunctions, incontinence (anal and urinary) and dysfunction are late side effects associated with cancer treatment in general, and patients treated for pelvic malignancies are at a higher risk. In Norway, the incidence of rectal cancer was 1329 in 2010. Advances in the treatment during the past few decades have led to fewer local recurrences and increased long-term survival, and today the relative survival is 66% for women and 64% for men. More patients are having sphincter-preserving surgery with low colorectal or ultralow coloanal anastomoses, and low anterior resection (LAR) is done in 70% of the patients with curative surgery. Unfortunately, many patients experience altered bowel function after LAR. Frequent bowel movements, urgency, evacuatory difficulties and fecal incontinence are common and distressing complications. These functional disturbances are seen in up to 50-60% of the patients, and most frequent when surgery is combined with neoadjuvant therapy. Urinary incontinence and decreased sexual function is also common in both men and women following rectal cancer treatment. In many surgical settings, patients with higher preoperative physical fitness rehabilitate more quickly and have fewer operative complications compared with patients who are less physically fit. Additionally, specific strength training of the pelvic floor muscles builds up muscle volume, elevates the location of the pelvic floor muscles and pelvic organs, and closes the levator hiatus thus providing improved structural support for the pelvic floor as well as more optimal automatic function. The aim of the present trial is to investigate whether exercise training including pelvic floor muscle training during preoperative radiotherapy can reduce symptoms of bowel, urinary and sexual dysfunction and affect the physiology of the anal sphincter muscle after LAR. In addition quality of life, cardiopulmonary parameters and postoperative complications will be studied.

NCT ID: NCT02473094 Terminated - Carcinoma Clinical Trials

Neoadjuvant Metformin in Association to Chemoradiotherapy for Locally Advanced Rectal Cancer

NEOMETRE
Start date: July 2015
Phase: Phase 2
Study type: Interventional

A phase II, randomized study of placebo versus metformin in association to chemotherapy with capecitabine and radiation in the neoadjuvant treatment of locally advanced (T3-4N0M0 or TxN1-2M0) rectal carcinomas.

NCT ID: NCT02465593 Terminated - Rectal Cancer Clinical Trials

A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer

Start date: June 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of PEP503(radio-enhancer). There are 2 portions in this study. - Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended injection volume of PEP503 for intratumor injection. - Expansion phase (Part II): Following the confirmation of the recommended volume of intratumor injection, 18 additional patients will be enrolled at the recommended volume level to evaluate for efficacy.

NCT ID: NCT02445456 Terminated - Rectal Cancer Clinical Trials

Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer

SentiRect
Start date: December 2016
Phase: N/A
Study type: Interventional

This study will assess whether the Sienna+/Sentimag system, which involves a magnetic tracer, is effective in identifying the sentinel lymph node in rectal cancer and whether it is then feasible to remove this lymph node during surgery to locally excise early rectal cancer.

NCT ID: NCT02324556 Terminated - Colorectal Neoplasm Clinical Trials

A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial

LATA
Start date: January 2015
Phase:
Study type: Observational

All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed. Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.

NCT ID: NCT02319304 Terminated - Clinical trials for Rectal Adenocarcinoma

Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma

GCC 1314
Start date: March 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effects, both good and bad, of adding very low dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over approximately 5.5 weeks is not given in this study. You will receive 6 cycles of FOLFOX (each cycle is 2 weeks) and you will also get an LDFRT to your pelvis given twice a day on the first two days of each cycle.

NCT ID: NCT02290574 Terminated - Clinical trials for Locally Advanced Rectal Cancer

Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial

NEOTREAT
Start date: November 2014
Phase: N/A
Study type: Interventional

The investigators start this prospective study to evaluate the efficacy of laparoscopic total mesorectal excision after concurrent chemo-radiation therapy with hyperthermia in locally advanced rectal cancer.

NCT ID: NCT02266849 Terminated - Ulcerative Colitis Clinical Trials

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study

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

Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo. Loperamide will be evaluated in relation to the following parameters - Change in ileostomy output in g/day in relation to oral intake - Quantification of the change in intestinal transit time using a radiopaque marker - The patient´s own assessment on which period they received Loperamide or Placebo

NCT ID: NCT02233595 Terminated - Clinical trials for Rectal Adenocarcinoma

Evaluation of Rectal Cancer Treatment Response Using PET/MRI

Rectal PET/MRI
Start date: October 15, 2014
Phase:
Study type: Observational

The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.

NCT ID: NCT02216149 Terminated - Colon Cancer Clinical Trials

Effects of S-1 and Capecitabine on Coronary Artery Blood Flow

FluoHeart
Start date: January 2015
Phase: Phase 2
Study type: Interventional

Fluoropyrimidine chemotherapy agents , such as 5-fluorouracil and capecitabine, are occasionally associated with cardiac toxicity. Clinical fluoropyrimidine cardiotoxicity is infrequent, but subclinical toxicity may be much more common. Cardiac toxicity may be less frequent with S-1 as compared with 5-fluorouracil and capecitabine, but head-to-head comparisons are lacking. The purpose of the study is to compare 2 measures of subclinical coronary artery microvascular dysfunction, the coronary flow reserve and the coronary flow response to a cold pressor test, in a patient population who are being treated for adenocarcinoma of the gastrointestinal tract with one of 2 oxaliplatin-containing regimens, either with oxaliplatin plus S-1 or with oxaliplatin plus capecitabine.