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Rectal Cancer clinical trials

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NCT ID: NCT03466424 Recruiting - Rectal Cancer Clinical Trials

Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer

Start date: August 1, 2022
Phase:
Study type: Observational

Preoperative radiotherapy followed by total mesorectal excision (TME) has been recommended as the preferred treatment method for locally advanced rectal cancer. Similar rates of local control, survival and toxicity were observed in preoperative long-course radiotherapy (LCRT) (45-50.4 Gy in 25-28 fractions) and short-course radiotherapy (SCRT) of 25 Gy in five fractions. For the convenience of SCRT, a growing number of patients tend to receive SCRT as preoperative radiotherapy. Although SCRT can shorten treatment interval and cut down the cost of treatment, it's pathological complete response (pCR) rate is relatively low (SCRT vs. LCRT: 0.7% vs. 16%). Hence, the optimal pattern of preoperative therapy of locally advanced rectal cancer still deserves to be explored. Previous studies have confirmed the feasibility and safety of 30Gy/5 fractions in SCRT of rectal cancer and verified that SCRT followed by mFOLFOX6 chemotherapy can improve the pCR rates. Therefore, investigators aimed to establish a dose escalation mode of SCRT (5×6Gy/7Gy/8Gy) followed by four cycles of modified FOLFOX6(mFOLFOX6) chemotherapy to test the safety and efficacy in treating locally advanced rectal cancer.

NCT ID: NCT03465982 Recruiting - Rectal Cancer Clinical Trials

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

TiMiSNAR
Start date: June 5, 2018
Phase: N/A
Study type: Interventional

The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.

NCT ID: NCT03459235 Recruiting - Surgery Clinical Trials

Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.

Rectqol
Start date: March 20, 2018
Phase: N/A
Study type: Interventional

Total mesorectal excision and neoadjuvant radio-chemotherapy have revolutionized the management of rectal cancer allowing an increase in survival (between 55 and 68% at 5 years) and allowing a decrease of local recurrence (under 10%) and allowing to push the limits of sphinctyer saving procedures. Parallel to the oncological findings, evaluating quality of life and functionnals sequelae has become a priority as highlighted by the second axis of "plan cancer 2014-2019". The prevalence of digestive functional sequelae decrease during the first two years after surgery. However, these results are difficult to analyse due to the heterogeneity of used scores in medical litterature. The low anterior resection syndrom associate poly-exoneration, gas and / or stool incontinence, urgency and stool splitting. The score of low anterior resection " LARS score " validated in Danemark in 2012 allow us to understand the complexity of these sequelae and to measure their impact on the quality of life of patients, that's why he is currently recommended. In the long term, almost two out of three patients suffer from this syndrom, with half of the patients in a severe form. However, its prevalence and severity are often underestimated by practitioners. It leads to inappropriate therapeutic measures. The aim of this study is to evaluate the impact of digestive and genito-urinary sequelae on quality of life from validated scores in patients operated curatively of rectal cancer using a population study. This study should include 676 patients with rectal cancer treated in calvados and alive at 2 years of their proctectomy without local or general recurrence.

NCT ID: NCT03436719 Recruiting - Rectal Cancer Clinical Trials

Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.

Start date: November 6, 2017
Phase: N/A
Study type: Interventional

This is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.

NCT ID: NCT03431428 Recruiting - Surgery Clinical Trials

Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients

Start date: January 1, 2018
Phase: Phase 3
Study type: Interventional

The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.

NCT ID: NCT03416699 Recruiting - Rectal Cancer Clinical Trials

Chinese TaTME Registry Collaborative

Start date: November 15, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Total mesorectal excision (TME) is the gold standard procedure for treating rectal cancer. However, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic stenosis, the traditional laparoscopic or open surgery is not easy to conduct. Transanal total mesorectal excision (TaTME) might serve as a better procedure for these patients, for it might ease the dissection of the low mesorectum. So far, several studies have showed the promising results of TaTME, but the multi-center data in China is still lacking. This nationwide registry study included more than 30 Chinese hospitals, aiming at obtaining data on the safety and efficacy of this procedure in Chinese patients with rectal cancer and encouraging future research in this field.

NCT ID: NCT03413904 Recruiting - Rectal Cancer Clinical Trials

Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer.

taTME
Start date: March 27, 2018
Phase: N/A
Study type: Interventional

This study is designed as a prospective, multi-center, randomized, open-labelled, parallel group, non-inferiority trial. The aim of this study is to evaluate the TaTME technique compared with conventional laparoscopic rectal surgery, focusing on, anastomotic dehiscence, conversion rate to open surgery, hospital stay and long-term functional outcomes.

NCT ID: NCT03393234 Recruiting - Rectal Cancer Clinical Trials

Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer

IDAVON
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.

NCT ID: NCT03351959 Recruiting - Rectal Cancer Clinical Trials

Complete Pathologic Response Rectal Cancers

CORSiCA
Start date: January 1, 2018
Phase:
Study type: Observational

Background. About 20% of rectal cancers who underwent neoadjuvant treatment (neoCHT-RT) achieve a pathological complete response in the surgical specimen(ypT0); however, about 10% of ypT0 present metastatic nodes (N+). Although seldom analyzed, ypT0N+ identification could be crucial in order to tailor treatments. Hypotheses. The two hypotheses to test are if we can identify ypT0N+ and if N+ is an independent prognostic factor. Aim 1. To create a large Database (DB) of ypT0. Aim 2. To compare ypT0N0 vs ypT0N+ with respect of their clinical/radiological/molecular features. Aim 3. To investigate long term results. Preliminary Study. Dr Lorenzon is the PI of an Italian retrospective multicentric study conducted on 260 ypT0 focused on treatment and outcomes. Design. The PI will operate in partnership with the European Society of Surgical Oncology (ESSO). A DB will be used by ESSO-affiliated centres for collecting the clinical, pathological and radiological data of ypT0N0/N+, previously treated (last 5 years) and prospectively enrolled (6 months + 2 years of follow-up); each centre will provide a junior (<40 yrs) member for data collection and a senior investigator .for data validation; all the analyses will be centralized by the PI. ypT0N0 and ypT0N+ will be compared for the clinical/pathological variables, for the gene expression profiles of pre-neoCHT-RT biopsies (grant requested). Uni-multivariate survival analyses (end-points: OS, DFS, DSS) will be conducted at 2 years of follow-up. Impact. This is the first study aimed to investigate ypT0N+ features; their accurate identification could lead to treat safely thousands of ypT0N0/year with local excisions leaving major surgery for N+ patients. Results will change practice and reduce considerably health-related costs; moreover, the molecular profiles will open new frontiers of research.

NCT ID: NCT03325361 Recruiting - Rectal Cancer Clinical Trials

The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage

Start date: October 2017
Phase: N/A
Study type: Interventional

Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.