Colorectal CancerPhase 3NCT00268463
Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer
A Phase 3 study testing capecitabine, floxuridine and oxaliplatin in people with Colorectal Cancer and Metastatic Cancer, run by NSABP Foundation Inc at 31 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- capecitabine, floxuridine and oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 31 sitesUnited States
- Study dates
- Jan 2006to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically* or cytologically confirmed colorectal adenocarcinoma
- No other cellular type (e.g., sarcoma, lymphoma, or carcinoid) NOTE: *If the primary colorectal tumor and the hepatic lesions have been identified at the same time and it is not possible to biopsy the colorectal lesion, the patient will be eligible without histologic confirmation of the colorectal primary cancer as long as other radiographic studies or scans document the characteristics of a colorectal cancer
- Synchronous or metachronous metastatic disease confined to the liver
- No more than 6 hepatic metastatic lesions that can potentially be resected or ablated
- For patients presenting with synchronous lesion(s) in the colon and/or rectum, the primary tumors must, in the opinion of the investigator, appear to be completely resectable
- Must be able to undergo surgery and/or ablation within 28 days following randomization
- No evidence of extrahepatic metastases
- No prior colorectal metastases
- No recurrent colorectal cancer concurrent with hepatic metastases
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 5 years, excluding their colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
- No other malignancy within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, basal cell or squamous cell skin cancer, or carcinoma of the colon or rectum
- Absolute granulocyte count ≥ 1,200/mm^3
- Platelet count ≥ 100,000/mm^3
- PT/international normalized ratio (INR) ≤ 1.5 unless patient is on therapeutic doses of anticoagulant medication
- Total bilirubin ≤ upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 ULN
- aspartate aminotransferase (AST) ≤ 2.5 times ULN
- Calculated creatinine clearance > 50 mL/min
- Not pregnant or lactating
- Negative pregnancy test
- Patients with child bearing potential must agree to use adequate contraception
- Able to swallow oral medication
- No preexisting chronic hepatic disease (e.g., chronic active hepatitis or cirrhosis)
- No grade 3 or 4 anorexia or nausea
- No vomiting ≥ grade 2
- No clinically significant peripheral neuropathy defined as ≥ grade 2 neurosensory or neuromotor toxicity
- No psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
- Prior adjuvant fluorouracil alone or in combination with levamisole, leucovorin calcium, irinotecan hydrochloride, or oxaliplatin allowed if these regimens were completed > 6 months ago
- No prior resection/ablation, hepatic arterial infusion therapy, or any systemic chemotherapy for metastatic disease
- Prior excisional biopsy allowed
- No prior radiotherapy to the liver
- No concurrent bevacizumab in patients who have had pump/catheter placement receiving hepatic arterial infusion of floxuridine
- Patients who meet specific situations outlined in the protocol and who have not had pump placement may receive bevacizumab at the physician's discretion
- No concurrent halogenated antiviral agents such as sorivudine or brivudine in patients receiving fluorouracil, floxuridine, or capecitabine
- No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) as primary prophylaxis for neutropenia
- Following neutropenic events, these drugs may be used at the physician's discretion during subsequent cycles
- No other concurrent cancer therapy
- No other concurrent investigational agents
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, 21237
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, 94524-4110
Geisinger Medical Center
Danville, Pennsylvania, 17822-0001
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201
Virginia Oncology Associates - Hampton
Hampton, Virginia, 23666
Borgess Medical Center
Kalamazoo, Michigan, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Central Baptist Hospital
Lexington, Kentucky, 40503-9985
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, 92357
Louisville Oncology at Norton Cancer Center
Louisville, Kentucky, 40202
UMC Southwest Cancer and Research Center
Lubbock, Texas, 79415-3364
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, 26506
CCOP - Ochsner
New Orleans, Louisiana, 70121
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, 97210
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403-3089
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, 94596
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, 94598
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients With Resected or Ablated Liver Metastases From Colorectal Cancer
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and capecitabine together with an hepatic arterial infusion with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.
PURPOSE: This randomized phase III trial is studying oxaliplatin, capecitabine, and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare progression-free interval (PFI) in patients undergoing surgical resection and/or ablation for hepatic metastases from colorectal cancer treated with adjuvant therapy comprising oxaliplatin and capecitabine with vs without hepatic arterial infusion of floxuridine.
Secondary
- Compare overall survival and liver PFI between the two treatment groups.
- Assess toxicity in each of the treatment regimens.
- Compare self-reported symptoms between two treatment groups.
- Compare quality of life in each of the treatment regimens.
Tertiary
- Examine the prognostic worth, in terms of PFI, of specific molecular markers in hepatic metastases.
OUTLINE: This is a randomized study. Patients are stratified according to intended surgical technique (surgical resection alone vs cryoablation or radiofrequency ablation [RFA] alone vs combination of resection and ablation) and prior adjuvant chemotherapy regimen (chemotherapy with vs without oxaliplatin vs no chemotherapy). Patients are randomized to 1 of 2 treatment arms.
All patients undergo surgical resection and/or hepatic cryoablation or RFA to remove a maximum of 6 colorectal hepatic metastases. Patients randomized to arm II also undergo intra-arterial catheter and if applicable, pump placement.
- Arm 1 (oxaliplatin and capecitabine): Within 4-6 weeks after surgery and/or ablation, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
- Arm 2 (oxaliplatin, capecitabine, and hepatic arterial infusion of floxuridine): Within 4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity. Beginning with course 5, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 4-6 weeks after surgery or ablation, approximately 18 weeks after beginning of chemotherapy, and 4-6 weeks after beginning the last cycle of chemotherapy.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- capecitabine, floxuridine, oxaliplatin
- Keywords
- liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called Xeloda
Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1
Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles: Arm 2
floxuridineDrug
Also called FUDR
Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles
oxaliplatinDrug
Also called Eloxatin
Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1
Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles: Arm 2
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Capecitabine + Oxaliplatin | Active comparator | Within 4-6 weeks after surgery and/or ablation, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: capecitabine; Drug: oxaliplatin |
| Arm 2: Floxuridine + Oxaliplatin + Capecitabine | Experimental | Within 4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 cycles in the absence of unacceptable toxicity. Beginning with cycle 5, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 cycles. Receives: Drug: capecitabine; Drug: floxuridine; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Interval (PFI)
Time to first recurrence of colon cancer at any site
Measured: Time from randomization through year 5
Secondary outcomes (4)
Liver PFI as Measured by Time to Hepatic Progression.
Measured: Time from randomization through year 5
Survival as Measured by Time to Death From Any Cause.
Measured: Time from randomization through year 5
Scales Specific to Social/Family, Emotional, and Functional Well-being, Perceived Convenience of Care, and Self-reported Symptoms
Measured: Prior to randomization, 4-6 weeks after surgery, 18 weeks after starting chemotherapy and after completion of chemotherapy
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Trial Outcome Index at Baseline, at 4-6 Weeks Following Surgery (Before Initiation of Chemotherapy), and Periodically During Study
Measured: Prior to randomization, 4-6 weeks after surgery, 18 weeks after the start of chemotherapy and after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: The study was terminated due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Norman Wolmark, MD, Principal investigator, NSABP Foundation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268463
- Sponsor's protocol ID
- NSABP C-09
- Other IDs
- U10CA012027
- Status last verified
- May 2013
- First submitted
- 20 Dec 2005
- Last updated
- 15 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients With Resected or Ablated Liver Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00268463
- Acronym / sponsor ID
- NSABP C-09
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to low accrual.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Dec 2005 (estimated)
- Results
- Posted 15 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and capecitabine together with an hepatic arterial infusion with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.
PURPOSE: This randomized phase III trial is studying oxaliplatin, capecitabine, and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- Compare progression-free interval (PFI) in patients undergoing surgical resection and/or ablation for hepatic metastases from colorectal cancer treated with adjuvant therapy comprising oxaliplatin and capecitabine with vs without hepatic arterial infusion of floxuridine.
Secondary
- Compare overall survival and liver PFI between the two treatment groups.
- Assess toxicity in each of the treatment regimens.
- Compare self-reported symptoms between two treatment groups.
- Compare quality of life in each of the treatment regimens.
Tertiary
- Examine the prognostic worth, in terms of PFI, of specific molecular markers in hepatic metastases.
OUTLINE: This is a randomized study. Patients are stratified according to intended surgical technique (surgical resection alone vs cryoablation or radiofrequency ablation [RFA] alone vs combination of resection and ablation) and prior adjuvant chemotherapy regimen (chemotherapy with vs without oxaliplatin vs no chemotherapy). Patients are randomized to 1 of 2 treatment arms.
All patients undergo surgical resection and/or hepatic cryoablation or RFA to remove a maximum of 6 colorectal hepatic metastases. Patients randomized to arm II also undergo intra-arterial catheter and if applicable, pump placement.
- Arm 1 (oxaliplatin and capecitabine): Within 4-6 weeks after surgery and/or ablation, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
- Arm 2 (oxaliplatin, capecitabine, and hepatic arterial infusion of floxuridine): Within 4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity. Beginning with course 5, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 4-6 weeks after surgery or ablation, approximately 18 weeks after beginning of chemotherapy, and 4-6 weeks after beginning the last cycle of chemotherapy.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Capecitabine + Oxaliplatin | Active comparator | Drug: capecitabine, Drug: oxaliplatinWithin 4-6 weeks after surgery and/or ablation, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. |
| Arm 2: Floxuridine + Oxaliplatin + Capecitabine | Experimental | Drug: capecitabine, Drug: floxuridine, Drug: oxaliplatinWithin 4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 cycles in the absence of unacceptable toxicity. Beginning with cycle 5, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| capecitabineAlso: XelodaOral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1 Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles: Arm 2 | Drug | Arm 1: Capecitabine + Oxaliplatin, Arm 2: Floxuridine + Oxaliplatin + Capecitabine |
| floxuridineAlso: FUDRContinuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles | Drug | Arm 2: Floxuridine + Oxaliplatin + Capecitabine |
| oxaliplatinAlso: EloxatinOxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1 Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles: Arm 2 | Drug | Arm 1: Capecitabine + Oxaliplatin, Arm 2: Floxuridine + Oxaliplatin + Capecitabine |
Primary outcome
Progression-free Interval (PFI)
Time frame: Time from randomization through year 5
Time to first recurrence of colon cancer at any site
4 secondary outcomes
Liver PFI as Measured by Time to Hepatic Progression.
Time frame: Time from randomization through year 5
Survival as Measured by Time to Death From Any Cause.
Time frame: Time from randomization through year 5
Scales Specific to Social/Family, Emotional, and Functional Well-being, Perceived Convenience of Care, and Self-reported Symptoms
Time frame: Prior to randomization, 4-6 weeks after surgery, 18 weeks after starting chemotherapy and after completion of chemotherapy
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Trial Outcome Index at Baseline, at 4-6 Weeks Following Surgery (Before Initiation of Chemotherapy), and Periodically During Study
Time frame: Prior to randomization, 4-6 weeks after surgery, 18 weeks after the start of chemotherapy and after completion of chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Norman Wolmark, MD principal investigator
NSABP Foundation Inc
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing capecitabine, floxuridine and oxaliplatin in people with Colorectal Cancer and Metastatic Cancer, run by NSABP Foundation Inc at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Interval (PFI) (time frame: Time from randomization through year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2013.