Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial

2017 ◽  
Vol 24 (3) ◽  
pp. 171-177 ◽  
Author(s):  
Tong Zhang ◽  
Yu-fei Yang ◽  
Bin He ◽  
Dan-hui Yi ◽  
Jie Hao ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Double Blind

Efficacy and safety of Qu Xie capsule in metastatic colorectal cancer: A double-blind, randomized, placebo-controlled trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15069-e15069
Author(s):  
Tong Zhang ◽  
Yufei Yang
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Treatment Group ◽  
Metastatic Colorectal Cancer ◽  
Ming Dynasty ◽  
Conventional Therapy ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind

e15069 Background:Qu Xie capsule was discovered by Li Zhongzi, a traditional Chinese Medicine doctor in the Ming Dynasty. Doctor Yang Yufei improved Qu Xie capsule and used it clinically for more than 10 years. In a previous study, we found that Qu Xie capsule reduces the risk of stage II–III colorectal cancer postoperative recurrence and metastasis and prolongs the survival of patients with metastatic colorectal cancer (mCRC). The present clinical trial was designed to verify the efficacy and safety of Qu Xie capsule in patients with mCRC. Methods: The present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio. The treatment group received conventional therapy combined with Qu Xie capsule. The control group was treated with conventional therapy combined with placebo. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Results: A total of 121 patients were enrolled and 60 patients were eligible; 54 patients were analyzed. The median OS was 23 months in the treatment group [95% confidence interval (CI) 15–not calculated] vs. 14 months in the control group (95% CI 11–22) (Kaplan–Meier, Log-rank p = 0.060). The OS of the treatment group tended to be longer than that of the control group, although the difference was not significant. This may have been related to the small sample size. In the subgroups of patients < 65 years old, left-sided colon, and ≥second-line therapy, the treatment group showed a significant survival benefit compared with the control group ( p = 0.006, 0.038, 0.013). There were no significant differences between the two groups in PFS. Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group. In the treatment group, one patient had 'abdominal pain' once, which may have been related to the Qu Xie capsule. No other related adverse events were reported. Conclusions:Qu Xie capsule showed good safety and efficacy, and can prolong the OS of patients with mCRC. Clinical trial information: ChiCTR-IOR-16009733.

A randomized, double-blind trial of fluorouracil plus placebo versus fluorouracil plus oral leucovorin in patients with metastatic colorectal cancer.

1993 ◽  
Vol 11 (10) ◽  
pp. 1888-1893 ◽  
Author(s):  
L R Laufman ◽  
R M Bukowski ◽  
M A Collier ◽  
B A Sullivan ◽  
R A McKinnis ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Treatment Failure ◽  
Metastatic Colorectal Cancer ◽  
Response Rate ◽  
Controlled Trial ◽  
Double Blind ◽  
Time To Treatment Failure ◽  
To Receive ◽  
Toxicity Pattern

PURPOSE A prospectively randomized trial was performed to determine whether the combination of fluorouracil (FU) plus leucovorin (FU-LV) administered orally is more effective than equitoxic FU for patients with metastatic colorectal cancer. PATIENTS AND METHODS A double-blind, placebo-controlled trial design was used to eliminate observer bias. An escalating FU dosing schedule was used to achieve equal toxicity. End points were response, time to treatment failure (TTF), and eight quality-of-life (QL) parameters. A crossover arm allowed FU-treated patients to receive FU-LV combination treatment after treatment failure. RESULTS Response rate was 32% for FU-LV versus 23% for FU (P = .15). Median TTF was 22 versus 16 weeks (P = .27). Median survival time was 44 versus 54 weeks (P = .26). QL was the same for both treatments, except for days of hospitalization, which was greater for FU-LV (P < .001). Toxicities were similar to those previously reported for FU-LV and FU alone. CONCLUSION Oral LV-FU produces the same efficacy and toxicity pattern as has been reported for intravenous LV-FU. When FU-LV is compared with equitoxic doses of FU, there is no difference in patient outcome. These results suggest that patients with advanced disease should receive FU at doses adequate to produce toxicity.

Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study

2007 ◽  
Vol 25 (30) ◽  
pp. 4779-4786 ◽  
Author(s):  
Charles S. Fuchs ◽  
John Marshall ◽  
Edith Mitchell ◽  
Rafal Wierzbicki ◽  
Vinod Ganju ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Controlled Trial ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Primary Study ◽  
Line Treatment ◽  
First Line ◽  
Double Blind ◽  
First Line Treatment

PurposeThis phase III study compared the safety and efficacy of the following three different irinotecan-containing regimens in the first-line treatment of metastatic colorectal cancer: irinotecan plus infusional fluorouracil (FU)/leucovorin (LV) (FOLFIRI), irinotecan plus bolus FU/LV (mIFL), and irinotecan plus oral capecitabine (CapeIRI).Patients and MethodsA total of 430 previously untreated metastatic colorectal cancer patients were randomly assigned to receive FOLFIRI (n = 144), mIFL (n = 141), or CapeIRI (n = 145). Patients were concurrently randomly assigned to a double-blind treatment with celecoxib or placebo. After a protocol amendment, an additional 117 patients were randomly assigned to either FOLFIRI plus bevacizumab (FOLFIRI+Bev; n = 57) or mILF plus bevacizumab (mIFL+Bev; n = 60), whereas the CapeIRI arm was discontinued. The primary study end point was progression-free survival (PFS), with secondary end points of overall survival (OS), response rate, and toxicity.ResultsMedian PFS was 7.6 months for FOLFIRI, 5.9 months for mIFL (P = .004 for the comparison with FOLFIRI), and 5.8 months for CapeIRI (P = .015). Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (P = .09), and 18.9 months for CapeIRI (P = .27). CapeIRI was associated with higher rates of severe vomiting, diarrhea, and dehydration. After the amendment to add bevacizumab, the median survival time has not yet been reached for FOLFIRI+Bev and was 19.2 months for mIFL+Bev (P = .007). FOLFIRI+Bev was associated with a higher rate of ≥ grade 3 hypertension than mIFL+Bev.ConclusionFOLFIRI and FOLFIRI+Bev offered superior activity to their comparators and were comparably safe. An infusional schedule of FU should be the preferred irinotecan-based regimen in first-line metastatic colorectal cancer.

scholarly journals Efficacy and Safety of Proposed Bevacizumab Biosimilar BE1040V in Patients With Metastatic Colorectal Cancer: A Phase III, Randomized, Double-blind, Noninferiority Clinical Trial

2020 ◽  
Vol 42 (5) ◽  
pp. 848-859
Author(s):  
Hamid Rezvani ◽  
Seyed Mohammadreza Mortazavizadeh ◽  
Abolghasem Allahyari ◽  
Amirabbas Nekuee ◽  
Safa Najjar Najafi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind
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