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Rectal Cancer clinical trials

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NCT ID: NCT02292914 Recruiting - Prostate Cancer Clinical Trials

Prospective Analysis of Robot-Assisted Surgery

Start date: March 10, 2014
Phase: N/A
Study type: Interventional

The robot-assisted surgery allows three-dimensional view, detailed access of small structures, depth perception and articulated movements with wide latitude. Thinking about the inclusion of this branch of surgical outcome ICESP encouraged the training of their doctors and other health professionals , and has three tutors in the area of robot- assisted laparoscopic surgery , and various medical clinical staff , already trained , and already perform the procedure in other centers . The da Vinci ® Surgical System ( only existing in the World market) , consisting of one or two consoles for the surgeon and a tutor if necessary was adopted. Ergonomically designed, a stand next to the patient , with four interactive robotic arms , one of them , a vision system for high performance and the other three for exclusive EndoWrist ® instruments . Driven by the latest robotic technology , computer programs , frictionless transmission of manual controls , movements in scale and filtered made by the surgeon in the da Vinci ® System console are translated into precise movements of the instruments EndoWrist ® For surgeons , the da Vinci ® System offers superior 3D viewing with larger surgical precision ergonomic comfort and dexterity . For hospitals , the da Vinci ® Surgical System enables clinical and economic benefits of minimally invasive surgery are applied to a broader base of patients cirúrgicos.The main objective is to evaluate the safety and effectiveness of robotic surgery in the surgical treatment of cancer in operations below, as their specialties : Digestive , Urology , Gynecology , Head and Neck and Thorax . This is a prospective study lasting 36 months , where 1120 patients with surgical diseases in programming for the following operations will be studied : transthoracic esophagectomy ; subtotal gastrectomy with lymphadenectomy ; partial pancreatectomy ; resection of the rectum ; prostatectomy ; cystectomy ; partial nephrectomy ; hysterectomy with or without pelvic and paraaortic lymphadenectomy ; resection of malignant tumors of the mouth and orofaringolaringe and lung lobectomy . Patients will come from the outpatient services of the Institute of Cancer of São Paulo - ICESP

NCT ID: NCT02288078 Recruiting - Rectal Cancer Clinical Trials

Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)

Start date: October 2014
Phase: Phase 2
Study type: Interventional

The objective of this randomized placebo-controlled Phase 2 study is to evaluate prophylactic effects of dexamethasone for fatigue and malaise (weakness, lethargy, malaise) resulting from regorafenib treatment, as well as to assess treatment continuation of regorafenib.

NCT ID: NCT02280070 Recruiting - Rectal Cancer Clinical Trials

RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).

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

To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.

NCT ID: NCT02279771 Recruiting - Rectal Cancer Clinical Trials

Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

LessStoReS
Start date: January 2015
Phase: N/A
Study type: Interventional

Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy

NCT ID: NCT02277158 Recruiting - Rectal Cancer Clinical Trials

Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.

Start date: November 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer

NCT ID: NCT02195141 Recruiting - Rectal Cancer Clinical Trials

Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

Start date: January 2014
Phase: Phase 2
Study type: Interventional

Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.

NCT ID: NCT02140723 Recruiting - Rectal Cancer Clinical Trials

p53 and Response to Preoperative Radiotherapy for T2 and T3

PART1
Start date: August 2011
Phase:
Study type: Observational

Background: Meta-analyses of large randomized trials proved the superiority of preoperative short course radiation and surgery, as compared with surgery alone. Short course radiation results in a 50% reduction in terms of local relapse in stage II and III rectal cancer patients. Patients with complete pathological remission additionally show a significant survival benefit. Complete pathological remission (pCR) occurs in 8% after preoperative radiation and in >16% if the interval between radiation and surgery is at least 8 weeks. It is generally accepted that mutations in the TP53 gene represent a crucial defect in the apoptosis pathway. Radiation therapy is suggested to act via induction of apoptosis in irradiated cells. Therefore, it is expected that a defect in the TP53 gene has an effect on the success of radiation therapy. Currently available imaging tools are hardly able to diagnose response to radiation therapy correctly, as this does not essentially correlate with tumor size. Method: Aim of this prospective observation study is to strengthen the hypothesis that the TP53 genotype is a promising marker to predict response to radiation therapy in rectal cancer patients. Consequently, the expected results will justify prospective, randomized intervention trials to obtain level of evidence I for the p53 marker hypothesis. Trial endpoint is downstaging and pCR rate. Tumor stage and pathological remission will be evaluated by MRT and pathohistology and correlated to the TP53 genotype of the diagnostic biopsy. Additionally, we will investigate the applicability of novel imaging modalities in magnet resonance tomography to monitor response to radiotherapy. The objective of this study is - to evaluate the effect of a genetic tumor marker (TP53 genotype) on the response to preoperative short course radiation (in terms of downstaging and pCR rate) - to evaluate the applicability of novel magnet resonance tomography imaging modalities to monitor response to preoperative short time radiation. Conclusion: The prospective evaluation of the potential predictive marker TP53 may bring us one-step closer to an individualized therapy regimen, which allows the restriction of preoperative radiation in rectal cancer to those patients who will benefit.

NCT ID: NCT02081547 Recruiting - Rectal Cancer Clinical Trials

IPC Status as a Surgical Quality Marker in Rectal Cancer Surgery

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

Risk of local recurrence after rectal surgery is nationally 8% after curative surgery to 5%. Local recurrence rate after curative surgery varies between 3-7% in the variety of regions in the country. It is well known that the surgical technique total mesorectal excision (TME) has led to improved prognosis after rectal cancer surgery. TME surgery is difficult to perform and different factors affect the quality of TME preparations. Injuries in mesorectal fascia has been reported in up to 20% of patients who underwent TME surgery and most surgeons agree that this may be important for recurrences. However, it is unclear to what extent a damaged mesorectal fascia can be related to a worsening of prognosis in patients with rectal cancer. Adjuvant oncological treatment in form of chemotherapy after surgery, is offers patients with unfavorable tumors based on the pathological examination. Patients with favorable tumors (less advanced) are not offered chemotherapy, even if the surgical technique was not optimal, ie. that there is damage in the mesorectal fascia, as evidence for this is lacking. The presence of intraperitoneal cancer cells (IPC) is related to histopathological tumor stage of colorectal cancer. Incidence of IPC of intraperitoneal tumors (rectal cancer patients with tumors below the peritoneal reflection) is unclear. Assessment of IPC status with cytology and immunohistochemistry is technically easy and could after TME surgery identify those patients who have an increased risk of tumor recurrence. In a positive IPC status, the patient would possibly benefit from either postoperative radiotherapy if the patient did not receive preoperative therapy, or postoperative oncological chemotherapy. Tumour cells may be lysed in sterile water, and some surgeons rinse the abdominal cavity and the bowel distally to the tumour. Neither rinsing the abdomen or rectum in colorectal cancer is routinely occurring and the clinical benefit has not been established. The value of rinsing the abdomen after TME-surgery could also be studied by IPC status. The study hypothesis is that the IPC status is dependent on the surgical quality of the specimen after TME-surgery in rectal cancer patients, and its presence leads to increased risk of local recurrence.

NCT ID: NCT02036112 Recruiting - Rectal Cancer Clinical Trials

Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer

ELAPE
Start date: August 2013
Phase: N/A
Study type: Interventional

An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.

NCT ID: NCT02022852 Recruiting - Rectal Cancer Clinical Trials

Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

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

Compared curative effect,safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.