scholarly journals Korean Society of Coloproctology (KSCP) trial of cONsolidation Chemotherapy for Locally advanced mid or low rectal cancer after neoadjUvant concurrent chemoraDiothErapy: a multicenter, randomized controlled trial (KONCLUDE)

BMC Cancer ◽  
2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Chang Woo Kim ◽  
Byung Mo Kang ◽  
Ik Yong Kim ◽  
Ji Yeon Kim ◽  
Sun Jin Park ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Randomized Controlled Trial ◽  
Concurrent Chemoradiotherapy ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Low Rectal Cancer ◽  
Consolidation Chemotherapy ◽  
Korean Society ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Consolidation chemotherapy for locally advanced mid- or low rectal cancer after neoadjuvant concurrent chemoradiotherapy: A multicenter, randomized controlled trial (KONCLUDE).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. TPS813-TPS813
Author(s):  
Chang Woo Kim ◽  
Ik Yong Kim ◽  
Suk-Hwan Lee
Keyword(s):  
Rectal Cancer ◽  
Concurrent Chemoradiotherapy ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Low Rectal Cancer ◽  
Consolidation Chemotherapy ◽  
Primary Endpoints ◽  
Multicenter Randomized Controlled Trial

TPS813 Background: Chemoradiotherapy (CRT) followed by total mesorectal excision (TME) has been a standard treatment option for locally advanced mid or low rectal cancer with improved local control. However, systemic recurrence after the standard therapy is the most important failure of treatment, and several efforts have been trying to overcome it. Consolidation chemotherapy is adding several cycles of chemotherapy between neoadjuvant CRT and TME. It could increase the proportion of pathologic complete response (pCR), subsequently could show better oncologic outcomes. Methods: Patients with advanced mid or low rectal cancer who received neoadjuvant CRT will be included after screening. They will be randomized and assigned to underwent TME followed by adjuvant chemotherapy of 8 cycles (control arm) or receive 3 cycles of chemotherapy before TME, and receive 5 cycles of chemotherapy (experimental arm). The primary endpoints are pathologic complete response and 3-year disease-free survival, and the secondary endpoints are radiotherapy-related complications, R0 resection, tumor response rate, surgery-related morbidity, and peripheral neuropathy 3 year after the surgery. The authors hypothesize that the experimental arm would show a 15% improvement in two primary endpoints, compared with the control arm. Based on the superiority design, an one-sided log-rank test with α-error of 0.025 and a power of 90% was conducted. Allowing for a drop-out rate of 10%, 316 patients (158 per arm) will need to be recruited. The accrual period is 2 years and the follow-up period is 3 years. Discussion: KONCLUDE (A Korean society of coloproctology trial: cONsolidation Chemotherapy for Locally advanced mid or low rectal cancer after neoadjUvant concurrent chemoraDiothErapy: A multicenter, randomized controlled trial) is expected to provide evidence to support clear treatment guidelines for patients with locally advanced rectal cancer. Clinical trial information: 02843191.

scholarly journals Role of diversion ileostomy in low rectal cancer: A randomized controlled trial

2014 ◽  
Vol 12 (9) ◽  
pp. 945-951 ◽  
Author(s):  
Mukhtar Thoker ◽  
Imtiaz Wani ◽  
Fazl Q. Parray ◽  
Nawab Khan ◽  
Shabeer A. Mir ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Low Rectal Cancer ◽  
Randomized Controlled

Robotic vs. laparoscopic vs. open abdominoperineal resection for low rectal cancer: Short-term outcomes of a single-center prospective randomized controlled trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3603-3603 ◽  
Author(s):  
Ye Wei ◽  
Jianmin Xu ◽  
Li Ren ◽  
Qingyang Feng ◽  
Guodong He ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rectal Cancer ◽  
Randomized Controlled Trial ◽  
Complication Rate ◽  
Open Surgery ◽  
Resection Margin ◽  
Controlled Trial ◽  
Low Rectal Cancer ◽  
Postoperative Complication Rate ◽  
Randomized Controlled

3603 Background: Currently, robotic surgery for rectal cancer using da Vinci System is common. However, there is almost no clinical trial reported. This randomized controlled trial aims to compare the safety and efficacy of robotic, laparoscopic and open abdominoperineal resection (APR) for low rectal cancer. Methods: From September 2013 to August 2016, patients aged from 18 to 75 years, with low rectal cancer within 5 cm from anal verge, clinical T1 to T3, no distant metastases, were randomly assigned to receive either robotic procedures (RAP), laparoscopic procedures (LAP) or open surgery (OS) for APR in 1:1:1 ratio. The primary endpoint was postoperative complication rate. This study is registered with ClinicalTrials.gov (NCT01985698). Results: Totally 406 patients were randomly assigned. Actually, 135 finished RAP, 131 finished LAP, and 137 finished OS (including 4 convert from LAP to OS). RAP had significantly lower postoperative complication rate (11.1%) than both LAP (21.4%, P = 0.023) and OS (27.7%, P = 0.001). Also, RAP reduced intraoperative hemorrhage (median [interquartile range], 100 [90-110] ml) than LAP (130 [100-150] ml, P < 0.001) and OS (150 [120-260] ml, P < 0.001). And RAP promoted postoperative recovery, with shorter days to first flatus (1.0 [1.0-2.0] day) than LAP (2.0 [2.0-3.0] day, P < 0.001) and OS (3.0 [2.0-4.0] day, P < 0.001), shorter days to first automatic urination (2.0 [2.0-3.0] day) than LAP (3.0 [2.0-4.0] day, P < 0.001) and OS (3.0 [2.0-4.0] day, P < 0.001), and shorter days to discharge (5.0 [5.0-6.0] days) than LAP (6.0 [5.0-7.0] days, P < 0.001) and OS (6.0 [5.0-7.0] day, P = 0.005). There was no significant difference in open conversion rate, resection margin involvement (including circumferential resection margin), number of lymph node harvested and pathological tumor stage. Conclusions: Robotic APR was safer, and reproduce equivalent surgical quality of conventional laparoscopic and open surgery. Also, it provided less injury and faster functional recovery. Clinical trial information: NCT01985698.

A multicenter, randomized, controlled trial comparing the occurrence of major adverse cardiovascular events (MACEs) in patients (pts) with prostate cancer (pc) and cardiovascular disease (CVD) receiving degarelix (GnRH receptor antagonist) or leuprolide (GnRH receptor agonist).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS395-TPS395 ◽  
Author(s):  
Susan F. Slovin ◽  
Chiara Melloni ◽  
Samreen Mansor-Lefebvre ◽  
Anders Neijber ◽  
Matthew Roe
Keyword(s):  
Randomized Controlled Trial ◽  
Gnrh Agonist ◽  
Receptor Agonist ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Gnrh Receptor ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

TPS395 Background: Epidemiological studies showed an association between GnRH agonists and a long-term increased risk of CVD, early after treatment initiation and with a higher risk seen in pts with pre-existing CVD. Retrospective pooled safety analyses of 6 randomized trials showed that significantly fewer pts treated with the GnRH receptor antagonists, degarelix, had a CV event or death compared with pts receiving a GnRH receptor agonist. In those studies showing an increased CV risk, Androgen-Deprivation Therapy (ADT) was primarily with GnRH receptor agonists. The mechanistic differences between GnRH antagonists and agonists, including testosterone surge and time to suppression at initiation, effect on follicle-stimulating hormone and on GnRH receptors e.g. T-lymphocytes in atherosclerotic plaque, raises the possibility of different CV risk profiles. The PRONOUNCE trial is the first to prospectively assess whether a GnRH agonist/antagonist can worsen pre-existing CVD; assess the impact of GnRH agonist/antagonist on CV risk biomarkers; and effects of hormonal therapy on immune system. Methods: PRONOUNCE is a multi-center, randomized, controlled trial of 900 men with pc and concomitant CVD, assessing adjudicated MACEs, i.e. myocardial infarction (fatal, non-fatal), stroke (fatal, non-fatal), or death in pts randomized 1:1 to either degarelix or leuprolide according to label recommendations for up to one year. Eligibility include pre-defined CVD, metastatic or locally advanced pc; high-risk disease with plan for definitive radiation therapy (RT); recurrence after local therapy with PSA doubling time <12 months; or salvage RT with neoadjuvant/adjuvant ADT for at least 12 months. Serum samples are collected for the analysis of various CV, inflammatory, and immune biomarkers. The primary endpoint will be based on Kaplan-Meier estimator of survival function and stratified for age group and region. Interim analysis is scheduled when 50% of MACE events have occurred allowing the DSMB to recommend for sample size correction. Clinical trial information: NCT02663908.

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