scholarly journals ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer

2016 ◽  
Vol 119 (3) ◽  
pp. 381-389 ◽  
Author(s):  
Jon D. Emery ◽  
Michael Jefford ◽  
Madeleine King ◽  
Dickon Hayne ◽  
Andrew Martin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
Phase Ii ◽  
Controlled Trial ◽  
Shared Care ◽  
Randomized Controlled

scholarly journals Protocol for the ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer

BMJ Open ◽  
2014 ◽  
Vol 4 (3) ◽  
pp. e004972 ◽  
Author(s):  
Jon Emery ◽  
Juanita Doorey ◽  
Michael Jefford ◽  
Madeleine King ◽  
Marie Pirotta ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Controlled Trial ◽  
Shared Care ◽  
Randomised Controlled

scholarly journals Overcoming challenges in designing and implementing a phase II randomized controlled trial using a presurgical model to test a dietary intervention in prostate cancer

2008 ◽  
Vol 5 (3) ◽  
pp. 262-272 ◽  
Author(s):  
Wendy Demark-Wahnefried ◽  
Stephen L George ◽  
Boyd R Switzer ◽  
Denise C Snyder ◽  
John F Madden ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
Phase Ii ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Randomized Controlled

Screening decreases prostate cancer mortality: 11-year follow-up of the 1988 Quebec prospective randomized controlled trial

The Prostate ◽  
2004 ◽  
Vol 59 (3) ◽  
pp. 311-318 ◽  
Author(s):  
Fernand Labrie ◽  
Bernard Candas ◽  
Lionel Cusan ◽  
Jose Luis Gomez ◽  
Alain Bélanger ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
Cancer Mortality ◽  
Controlled Trial ◽  
Prostate Cancer Mortality ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

scholarly journals Electronic Trigger-Based Intervention to Reduce Delays in Diagnostic Evaluation for Cancer: A Cluster Randomized Controlled Trial

2015 ◽  
Vol 33 (31) ◽  
pp. 3560-3567 ◽  
Author(s):  
Daniel R. Murphy ◽  
Louis Wu ◽  
Eric J. Thomas ◽  
Samuel N. Forjuoh ◽  
Ashley N.D. Meyer ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
Electronic Health Record ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Diagnostic Evaluation ◽  
Health Record ◽  
Randomized Controlled ◽  
Cluster Randomized

Purpose We tested whether prospective use of electronic health record-based trigger algorithms to identify patients at risk of diagnostic delays could prevent delays in diagnostic evaluation for cancer. Methods We performed a cluster randomized controlled trial of primary care providers (PCPs) at two sites to test whether triggers that prospectively identify patients with potential delays in diagnostic evaluation for lung, colorectal, or prostate cancer can reduce time to follow-up diagnostic evaluation. Intervention steps included queries of the electronic health record repository for patients with abnormal findings and lack of associated follow-up actions, manual review of triggered records, and communication of this information to PCPs via secure e-mail and, if needed, phone calls to ensure message receipt. We compared times to diagnostic evaluation and proportions of patients followed up between intervention and control cohorts based on final review at 7 months. Results We recruited 72 PCPs (36 in the intervention group and 36 in the control group) and applied the trigger to all patients under their care from April 20, 2011, to July 19, 2012. Of 10,673 patients with abnormal findings, the trigger flagged 1,256 patients (11.8%) as high risk for delayed diagnostic evaluation. Times to diagnostic evaluation were significantly lower in intervention patients compared with control patients flagged by the colorectal trigger (median, 104 v 200 days, respectively; n = 557; P < .001) and prostate trigger (40% received evaluation at 144 v 192 days, respectively; n = 157; P < .001) but not the lung trigger (median, 65 v 93 days, respectively; n = 19; P = .59). More intervention patients than control patients received diagnostic evaluation by final review (73.4% v 52.2%, respectively; relative risk, 1.41; 95% CI, 1.25 to 1.58). Conclusion Electronic trigger-based interventions seem to be effective in reducing time to diagnostic evaluation of colorectal and prostate cancer as well as improving the proportion of patients who receive follow-up. Similar interventions could improve timeliness of diagnosis of other serious conditions.

Hepatectomy Followed by mFOLFOX6 Versus Hepatectomy Alone for Liver-Only Metastatic Colorectal Cancer (JCOG0603): A Phase II or III Randomized Controlled Trial

2021 ◽  
pp. JCO.21.01032
Author(s):  
Yukihide Kanemitsu ◽  
Yasuhiro Shimizu ◽  
Junki Mizusawa ◽  
Yoshitaka Inaba ◽  
Tetsuya Hamaguchi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Randomized Controlled

PURPOSE Adjuvant chemotherapy after hepatectomy is controversial in liver-only metastatic colorectal cancer (CRC). We conducted a randomized controlled trial to examine if adjuvant modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) is superior to hepatectomy alone for liver-only metastasis from CRC. PATIENTS AND METHODS In this phase II or III trial (JCOG0603), patients age 20-75 years with confirmed CRC and an unlimited number of liver metastatic lesions were randomly assigned to hepatectomy alone or 12 courses of adjuvant mFOLFOX6 after hepatectomy. The primary end point of phase III was disease-free survival (DFS) in intention-to-treat analysis. RESULTS Between March 2007 and January 2019, 300 patients were randomly assigned to hepatectomy alone (149 patients) or hepatectomy followed by chemotherapy (151 patients). At the third interim analysis of phase III with median follow-up of 53.6 months, the trial was terminated early according to the protocol because DFS was significantly longer in patients treated with hepatectomy followed by chemotherapy. With median follow-up of 59.2 months, the updated 5-year DFS was 38.7% (95% CI, 30.4 to 46.8) for hepatectomy alone compared with 49.8% (95% CI, 41.0 to 58.0) for chemotherapy (hazard ratio, 0.67; 95% CI, 0.50 to 0.92; one-sided P = .006). However, the updated 5-year overall survival (OS) was 83.1% (95% CI, 74.9 to 88.9) with hepatectomy alone and 71.2% (95% CI, 61.7 to 78.8) with hepatectomy followed by chemotherapy. In the chemotherapy arm, the most common grade 3 or higher severe adverse event was neutropenia (50% of patients), followed by sensory neuropathy (10%) and allergic reaction (4%). One patient died of unknown cause after three courses of mFOLFOX6 administration. CONCLUSION DFS did not correlate with OS for liver-only metastatic CRC. Adjuvant chemotherapy with mFOLFOX6 improves DFS among patients treated with hepatectomy for CRC liver metastasis. It remains unclear whether chemotherapy improves OS.

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