Colorectal Neoplasms Clinical Trial
— PHRACOfficial title:
A Prospective,Multi-Center,Randomized Control Trial of Preoperative Hepatic and Regional Arterial Chemotherapy(PHRAC) Using Oxaliplatin, Fluorodeoxyuridine(FUDR) and Mitomycin C(MMC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
The purpose of this study is to investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in patients receiving curative colorectal cancer resection.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2014 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 74 Years |
Eligibility |
Inclusion Criteria: - age < 75 years with histologically proven adenocarcinoma of the colon or rectum - no severe major organ dysfunction - WHO performance status of 0 or 1 - no prior cancer therapy - Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan Exclusion Criteria: - age >= 75 - severe major organ dysfunction - WHO performance status of >1 - prior cancer therapy - Stage I or Stage IV |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital, Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University | First Affiliated Hospital of Zhejiang University, Jiangyin People's Hospital, Liaoning Tumor Hospital & Institute, Ruijin Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai 9th People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 5 years disease-free survival | 5 years after operation | Yes | |
Secondary | 5 years overall survival and liver metastasis-free survival | 5 years after operation | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04552093 -
Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)
|
Phase 2/Phase 3 | |
Completed |
NCT04192565 -
A Prospective Investigation of the ColubrisMX ELS System
|
N/A | |
Completed |
NCT05178745 -
A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
|
||
Recruiting |
NCT03561350 -
Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
|
||
Recruiting |
NCT06128798 -
Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.
|
N/A | |
Recruiting |
NCT03602677 -
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
|
N/A | |
Completed |
NCT03631407 -
Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046)
|
Phase 2 | |
Withdrawn |
NCT04192929 -
Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy
|
N/A | |
Recruiting |
NCT03042091 -
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
|
Early Phase 1 | |
Terminated |
NCT02842580 -
De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT02889679 -
Underwater Resection of Non-pedunculated Colorectal Lesions
|
N/A | |
Completed |
NCT02564835 -
Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer
|
N/A | |
Completed |
NCT02149108 -
Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)
|
Phase 3 | |
Completed |
NCT02503696 -
Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
|
N/A | |
Completed |
NCT02599103 -
The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects
|
N/A | |
Completed |
NCT01669109 -
Hatha Yoga for Patients With Colorectal Cancer
|
N/A | |
Completed |
NCT01719926 -
Phase I Platinum Based Chemotherapy Plus Indomethacin
|
Phase 1 | |
Recruiting |
NCT01428752 -
Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer
|
N/A | |
Completed |
NCT01978717 -
General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer
|
N/A | |
Completed |
NCT01877018 -
Colorectal Cancer Screening in Primary Care
|
N/A |