Colorectal CancerPhase 3NCT00115765
PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
A Phase 3 study testing Oxaliplatin Based Chemotherapy, Panitumumab and Irinotecan Based Chemotherapy in people with Colorectal Cancer, run by Amgen.
Trial summary
The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Oxaliplatin Based Chemotherapy, Panitumumab and Irinotecan Based Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,053 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2005to 1 May 2009
- 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
Who may be able to join
- Adenocarcinoma of the colon or rectum
- Metastatic colorectal cancer (mCRC)
- Measurable disease per modified response evaluation criteria in solid tumors (RECIST) criteria
- ECOG performance status of 0 or 1
- Available paraffin-embedded tumor tissue (from primary tumor or metastasis) or unstained slides of paraffin-embedded tissue
- If history of other primary cancer, subject will be eligible only if she or he has:
Show all 21Show fewer
- Curatively resected non-melanomatous skin cancer;
- Curatively treated cervical carcinoma in situ;
- Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 5 years.
- Adequate hematologic data as follows:
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9 cells/L;
- Platelet count greater than or equal to 100 x 10^9/L;
- Hemoglobin greater than or equal to 9.0 g/dL. - Adequate renal function:
- Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN);
- Urinary protein dipstick of less than 2+ (if urinary dipstick 2+ or greater, then excretion of less than or equal to 1000 mg of protein per day as determined by 24-hour urine collection).
- Adequate hepatic function:
- Alkaline phosphatase less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
- Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase)(AST) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
- Alanine aminotransferase (serum glutamic-pyruvic transaminase) (ALT) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
- Bilirubin less than or equal to 2 x ULN. - Competent to comprehend, sign, and date an IRB-approved informed consent form
- Before any study-specific procedure, the appropriate written informed consent must be obtained.
Who cannot join
- Prior chemotherapy or biologic (i.e., antibody or vaccine) treatment for mCRC disease - Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before randomization - Radiotherapy within 14 days before randomization
- Elective and/or planned major surgical procedure to be performed during the course of this trial (surgery that arises as needed or necessary during the course of the study, not agreed a priori, will not make the subject ineligible)
- Major surgery within 28 days before randomization
- Central nervous system metastases
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest X-ray or CT-scan
- Clinically significant ascites
Show all 26Show fewer
- Preexisting bleeding diathesis or coagulopathy or the need for full-dose anticoagulation
- Any of the following within 1 year before randomization:
- Myocardial infarction;
- Unstable angina;
- Symptomatic congestive heart failure;
- Serious uncontrolled cardiac arrhythmia;
- Cerebrovascular accident or transient ischemic attack;
- Gastrointestinal ulcer or hemorrhage;
- Hemoptysis;
- Pulmonary embolism;
- Deep vein thrombosis, or other significant thromboembolic event.
- Regular use of non-steroidal anti-inflammatory agents
- Female subject of childbearing potential, not abstinent, and not willing to use contraceptives during the course of the study and for 6 months following the last dose of first-line treatment
- Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization
- Male subject, not abstinent, and not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of first-line treatment
- Subject known to be human immunodeficiency virus (HIV) positive
- Subject allergic to panitumumab or any components of panitumumab formulation
- History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
- Subject unwilling or unable to comply with study requirements
- Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
About this study
Official title: PACCE: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.
- Conditions
- Colorectal Cancer
- Being tested
- Oxaliplatin Based Chemotherapy, Panitumumab, Irinotecan Based Chemotherapy, Bevacizumab
- Keywords
- Panitumumab Advanced Colorectal Cancer Evaluation Study (PACCE Study), Colorectal, Colon, Rectal Cancer, Metastatic Colorectal, Cancer, EGFr, Clinical Trial, Panitumumab, ABX-EGF, Immunex, Abgenix, Amgen, Metastatic Colorectal Cancer, Oncology
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin Based ChemotherapyDrug
Also called FOLFOX 4, FOLFOX 5, Modified FOLFOX 6, FOLFOX 7
Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
PanitumumabDrug
Also called pmab, Vectibix
PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab.
Irinotecan Based ChemotherapyDrug
Also called FOLFIRI, Douillard
Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
BevacizumabDrug
Also called Avastin
Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin and bevacizumab without panitumumab | Active comparator | Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone. Receives: Drug: Oxaliplatin Based Chemotherapy; Drug: Bevacizumab |
| Irinotecan and bevacizumab plus panitumumab | Experimental | Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W Receives: Drug: Panitumumab; Drug: Irinotecan Based Chemotherapy; Drug: Bevacizumab |
| Irinotecan and bevacizumab without panitumumab | Active comparator | Irinotecan-based chemotherapy and Bevacizumab Q2W alone Receives: Drug: Irinotecan Based Chemotherapy; Drug: Bevacizumab |
| Oxaliplatin and bevacizumab plus panitumumab | Experimental | Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W Receives: Drug: Oxaliplatin Based Chemotherapy; Drug: Panitumumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (Oxaliplatin)
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression
Measured: Overall study
Objective Tumor Response Through Week 12 (Irinotecan)
Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum
Measured: Overall Study
Secondary outcomes (9)
Overall Survival (Oxaliplatin)
Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin
Measured: Overall study
Objective Tumor Response Rate (Oxaliplatin)
Best overall response of complete or partial response within oxaliplatin stratum
Measured: Overall study
Time to Progression (Oxaliplatin)
Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum
Measured: Overall Study
Time to Treatment Failure (Oxaliplatin)
Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum.
Measured: Overall study
Overall Survival (Irinotecan)
Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm.
Measured: Overall study
Progression-free Survival (Irinotecan)
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression
Measured: Overall Study
Objective Tumor Response Rate (Irinotecan)
Best overall response of complete or partial response within irinotecan stratum
Measured: Overall Study
Time to Progression (Irinotecan)
Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum
Measured: Overall Study
Time to Treatment Failure (Irinotecan)
Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the irinotecan stratum
Measured: Overall Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study start1 Jun 2005
- Primary completion31 May 2007
- Study completion1 May 2009
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115765
- Sponsor's protocol ID
- 20040249
- Status last verified
- Sep 2018
- First submitted
- 26 Jun 2005
- Last updated
- 17 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, Marshall J, Cohn A, McCollum D, Stella P, Deeter R, Shahin S, Amado RG. A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol. 2009 Feb 10;27(5):672-80. doi: 10.1200/JCO.2008.19.8135. Epub 2008 Dec 29.
PubMed 19114685Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.
PubMed 31378656Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.
PubMed 30679026
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACCE: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00115765
- Acronym / sponsor ID
- 20040249
- Conditions
- Colorectal Cancer
- Keywords
- Panitumumab Advanced Colorectal Cancer Evaluation Study (PACCE Study), Colorectal, Colon, Rectal Cancer, Metastatic Colorectal, Cancer, EGFr, Clinical Trial, Panitumumab, ABX-EGF, Immunex, Abgenix, Amgen, Metastatic Colorectal Cancer, Oncology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2005 (actual)
- Primary completion
- 31 May 2007 (actual)
- Study completion
- 1 May 2009 (actual)
- First posted
- 27 Jun 2005 (estimated)
- Results
- Posted 14 Sep 2010
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 assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin and bevacizumab without panitumumab | Active comparator | Drug: Oxaliplatin Based Chemotherapy, Drug: BevacizumabOxaliplatin-based chemotherapy and Bevacizumab Q2W alone. |
| Irinotecan and bevacizumab plus panitumumab | Experimental | Drug: Panitumumab, Drug: Irinotecan Based Chemotherapy, Drug: BevacizumabIrinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W |
| Irinotecan and bevacizumab without panitumumab | Active comparator | Drug: Irinotecan Based Chemotherapy, Drug: BevacizumabIrinotecan-based chemotherapy and Bevacizumab Q2W alone |
| Oxaliplatin and bevacizumab plus panitumumab | Experimental | Drug: Oxaliplatin Based Chemotherapy, Drug: Panitumumab, Drug: BevacizumabOxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Adenocarcinoma of the colon or rectum
- Metastatic colorectal cancer (mCRC)
- Measurable disease per modified response evaluation criteria in solid tumors (RECIST) criteria
- ECOG performance status of 0 or 1
- Available paraffin-embedded tumor tissue (from primary tumor or metastasis) or unstained slides of paraffin-embedded tissue
Key exclusion criteria (26 listed)
- Prior chemotherapy or biologic (i.e., antibody or vaccine) treatment for mCRC disease - Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before randomization - Radiotherapy within 14 days before randomization
- Elective and/or planned major surgical procedure to be performed during the course of this trial (surgery that arises as needed or necessary during the course of the study, not agreed a priori, will not make the subject ineligible)
- Major surgery within 28 days before randomization
- Central nervous system metastases
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest X-ray or CT-scan
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 |
|---|---|---|
| Oxaliplatin Based ChemotherapyAlso: FOLFOX 4, FOLFOX 5, Modified FOLFOX 6, FOLFOX 7Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. | Drug | Oxaliplatin and bevacizumab plus panitumumab, Oxaliplatin and bevacizumab without panitumumab |
| PanitumumabAlso: pmab, VectibixPanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. | Drug | Irinotecan and bevacizumab plus panitumumab, Oxaliplatin and bevacizumab plus panitumumab |
| Irinotecan Based ChemotherapyAlso: FOLFIRI, DouillardIrinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. | Drug | Irinotecan and bevacizumab plus panitumumab, Irinotecan and bevacizumab without panitumumab |
| BevacizumabAlso: AvastinBevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration . | Drug | Irinotecan and bevacizumab plus panitumumab, Irinotecan and bevacizumab without panitumumab, Oxaliplatin and bevacizumab plus panitumumab, Oxaliplatin and bevacizumab without panitumumab |
Primary outcome
Progression-Free Survival (Oxaliplatin)
Time frame: Overall study
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression
Objective Tumor Response Through Week 12 (Irinotecan)
Time frame: Overall Study
Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum
9 secondary outcomes
Overall Survival (Oxaliplatin)
Time frame: Overall study
Objective Tumor Response Rate (Oxaliplatin)
Time frame: Overall study
Time to Progression (Oxaliplatin)
Time frame: Overall Study
Time to Treatment Failure (Oxaliplatin)
Time frame: Overall study
Overall Survival (Irinotecan)
Time frame: Overall study
Progression-free Survival (Irinotecan)
Time frame: Overall Study
Objective Tumor Response Rate (Irinotecan)
Time frame: Overall Study
Time to Progression (Irinotecan)
Time frame: Overall Study
Time to Treatment Failure (Irinotecan)
Time frame: Overall Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19114685Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, Marshall J, Cohn A, McCollum D, Stella P, Deeter R, Shahin S, Amado RG. A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol. 2009 Feb 10;27(5):672-80. doi: 10.1200/JCO.2008.19.8135. Epub 2008 Dec 29.
- Derived from this study: PubMed 31378656Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.
- Derived from this study: PubMed 30679026Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.
- FDA-approved Drug LabelingLink provided by the sponsor.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Colorectal Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Recruiting
Family Communications After Genetic Testing
Colon Adenocarcinoma, Colorectal Adenocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
Left-sided Colorectal Cancer
RecruitingPhase 1/2
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Advanced NRAS-Mutant Melanoma, Advanced NRAS-Mutant Solid Tumors
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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxaliplatin Based Chemotherapy, Panitumumab and Irinotecan Based Chemotherapy in people with Colorectal Cancer, run by Amgen.
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 21 inclusion and 26 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: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 14 Sep 2010). 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 Survival (Oxaliplatin) (time frame: Overall study). The study lists 2 primary outcomes in all. 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 NCT00115765, which also lists 3 linked publications.
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 17 Oct 2018; AzTrials last refreshed its copy on 3 Nov 2026.