Colorectal NeoplasmsPhase 3PHRACNCT00643877
Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
A Phase 3 study testing Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR and surgery in people with Colorectal Neoplasms, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR and surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age >= 75
- severe major organ dysfunction
- WHO performance status of >1
- prior cancer therapy
- Stage I or Stage IV
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, 200032
jianmin xu, MD
About this study
Official 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.
Read the detailed description
We administered FUDR, MMC and Oxaliplatin as preoperative hepatic and regional arterial chemotherapy (PHRAC) to patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.
- Conditions
- Colorectal Neoplasms
- Being tested
- Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR, surgery
- Keywords
- Colorectal Neoplasms, Regional, Liver, Neoplasm Metastasis
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDRProcedure or surgery
PHRAC which included of two parts(common hepatic artery chemotherapy and main tumor supplying artery chemotherapy) was performed 7 days before surgery： common hepatic artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg main tumor supplying artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg
surgeryProcedure or surgery
radical surgery only
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | PHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery. Receives: Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR |
| A | No intervention | Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery. Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years disease-free survival
Measured: 5 years after operation
Secondary outcomes (1)
5 years overall survival and liver metastasis-free survival
Measured: 5 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Ruijin Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, First Affiliated Hospital of Zhejiang University, Jiangyin People's Hospital, Liaoning Cancer Hospital & Institute
- Investigators
- jianmin xu, MD, Study chair, department of general surgery, zhongshan hospital, fudan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643877
- Sponsor's protocol ID
- 2008-46
- Acronym
- PHRAC
- Status last verified
- Mar 2009
- First submitted
- 24 Mar 2008
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhu D, Xia J, Gu Y, Lin J, Ding K, Zhou B, Liang F, Liu T, Qin C, Wei Y, Ren L, Zhong Y, Wang J, Yan Z, Cheng J, Chen J, Chang W, Zhan S, Ding Y, Huo H, Liu F, Sun J, Qin X, Xu J. Preoperative Hepatic and Regional Arterial Chemotherapy in Patients Who Underwent Curative Colorectal Cancer Resection: A Prospective, Multi-center, Randomized Controlled Trial. Ann Surg. 2021 Jun 1;273(6):1066-1075. doi: 10.1097/SLA.0000000000004558.
PubMed 33214446
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00643877
- Acronym / sponsor ID
- PHRAC / 2008-46
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Regional, Liver, Neoplasm Metastasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Ruijin Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, First Affiliated Hospital of Zhejiang University, Jiangyin People's Hospital, Liaoning Cancer Hospital & Institute
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We administered FUDR, MMC and Oxaliplatin as preoperative hepatic and regional arterial chemotherapy (PHRAC) to patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDRPHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery. |
| A | No intervention | Procedure: surgeryAdjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- age >= 75
- severe major organ dysfunction
- WHO performance status of >1
- prior cancer therapy
- Stage I or Stage IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDRPHRAC which included of two parts(common hepatic artery chemotherapy and main tumor supplying artery chemotherapy) was performed 7 days before surgery： common hepatic artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg main tumor supplying artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg | Procedure or surgery | B |
| surgeryradical surgery only | Procedure or surgery | A |
Primary outcome
5 years disease-free survival
Time frame: 5 years after operation
1 secondary outcome
5 years overall survival and liver metastasis-free survival
Time frame: 5 years after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
- Derived from this study: PubMed 33214446Zhu D, Xia J, Gu Y, Lin J, Ding K, Zhou B, Liang F, Liu T, Qin C, Wei Y, Ren L, Zhong Y, Wang J, Yan Z, Cheng J, Chen J, Chang W, Zhan S, Ding Y, Huo H, Liu F, Sun J, Qin X, Xu J. Preoperative Hepatic and Regional Arterial Chemotherapy in Patients Who Underwent Curative Colorectal Cancer Resection: A Prospective, Multi-center, Randomized Controlled Trial. Ann Surg. 2021 Jun 1;273(6):1066-1075. doi: 10.1097/SLA.0000000000004558.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jianmin xu, MD study chair
department of general surgery, zhongshan hospital, fudan university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR and surgery in people with Colorectal Neoplasms, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jianmin xu, MD (008613501984869, xujmin@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 years disease-free survival (time frame: 5 years after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00643877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2009.