Colorectal CancerPhase 3NCT00070213
Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
A Phase 3 study testing FOLFOX regimen, capecitabine and fluorouracil in people with Colorectal Cancer, run by Medical Research Council at 4 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 0 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFOX regimen, capecitabine and fluorouracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Sep 2003to 1 Jun 2011
- 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 0 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of colorectal adenocarcinoma, defined by 1 of the following:
- Prior or current histologically confirmed primary adenocarcinoma of the colon or rectum with clinical/radiological evidence of advanced/metastatic disease
- Histologically or cytologically confirmed metastatic adenocarcinoma with clinical/radiological evidence of colorectal primary tumor
- Unidimensionally measurable disease
- Unfit and unsuitable for full-dose combination chemotherapy, which would include 1 of the following circumstances:
- Unsuitable or unwilling to be entered into any full-dose chemotherapy protocol
- Ineligible or unsuitable for first-line standard combination as per National Institute of Clinical Excellence guidance
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- Bilirubin no greater than 3 times upper limit of normal (ULN)
- AST or ALT no greater than 2.5 times ULN
Renal
- Creatinine clearance greater than 50 mL/min OR
- Glomerular filtration rate greater than 30 mL/min
Cardiovascular
- No uncontrolled angina
- No recent myocardial infarction
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No partial or complete bowel obstruction
- No concurrent severe uncontrolled medical illness that would preclude study treatment
- No psychiatric or neurological condition that would preclude giving informed consent or complying with oral study medication
- No other prior or concurrent malignant disease that would preclude study treatment or assessment of response
- No prior neuropathy greater than grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 4 months since prior adjuvant chemotherapy with fluorouracil with or without leucovorin calcium
- More than 1 month since prior rectal chemoradiotherapy with fluorouracil with or without leucovorin calcium
- No prior systemic palliative chemotherapy for metastatic disease
Endocrine therapy
- Not specified
Radiotherapy
- See Chemotherapy
Surgery
- Not specified
Other
- No concurrent brivudine or sorivudine
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Cookridge Hospital
Leeds, England, LS16 6QB
Clinical Trials and Research Unit of the University of Leeds
Leeds, England, LS2 9JT
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA
About this study
Official title: Drug Treatment for Bowel Cancer: Making the Best Choices When a Milder Treatment is Needed
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the progression-free survival of patients with metastatic colorectal adenocarcinoma treated with leucovorin calcium and fluorouracil with vs without oxaliplatin or capecitabine with vs without oxaliplatin.
- Compare the quality of life of patients treated with these fluorouracil-based vs capecitabine-based regimens.
Secondary
- Compare the failure-free and overall survival of patients treated with these regimens.
- Compare the toxic effects and adverse events associated with these regimens in these patients.
- Compare the limited health assessments of patients treated with these regimens.
- Compare the health economics associated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms and receive 12 weeks of therapy.
- Arm I (MdG regimen): Patients receive leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm II.
- Arm II (OxMdG regimen): Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study.
- Arm III (Cap regimen): Patients receive oral capecitabine twice daily on days 1-15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm IV.
- Arm IV (OxCap regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study.
All patients are then re-evaluated at least every 6 weeks and begin another 12 weeks of therapy at any evidence (e.g., clinical, radiological, or tumor marker) of disease progression. Patients with chemo-sensitive disease may repeat alternating 12-week therapy sessions and evaluation periods indefinitely.
Quality of life is assessed at baseline, at 12-14 weeks, at 24 weeks, and then every 3 months thereafter.
Patients are followed every 3 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 460 patients (115 per treatment arm) will be accrued for this study within 2 years.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFOX regimen, capecitabine, fluorouracil, leucovorin calcium, oxaliplatin
- Keywords
- adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV rectal cancer, stage IV colon cancer, recurrent rectal cancer, recurrent colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
capecitabineDrug
fluorouracilDrug
oxaliplatinDrug
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MdG (modified de Gramont) | Active comparator | 2 weekly 5FU/FA schedule Receives: Drug: FOLFOX regimen; Drug: fluorouracil; Drug: leucovorin calcium; Procedure: quality-of-life assessment |
| OxMdG (80%) for 12 weeks | Experimental | MdG + oxaliplatin Receives: Drug: FOLFOX regimen; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: quality-of-life assessment |
| Capcitabine | Experimental | Not described Receives: Drug: capecitabine; Procedure: quality-of-life assessment |
| OxCap | Experimental | Not described Receives: Drug: capecitabine; Drug: oxaliplatin; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr
Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr
Measured: PFS
Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 14 weeks
Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 14 weeks
Measured: Baseline and 14 weeks
Secondary outcomes (10)
Compare health assessment, including quality of life, in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap at baseline and 14 and 24 weeks
Compare health assessment, including quality of life, in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap at baseline and 14 and 24 weeks
Measured: Baseline, 14 and 24 weeks
Compare toxicity/adverse events in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Compare toxicity/adverse events in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Measured: post 24 weeks
Compare overall failure-free survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Compare overall failure-free survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Measured: post 24 weeks
Compare overall survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Compare overall survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Measured: post 24 weeks
Compare health economics in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Compare health economics in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Measured: Baseline, 14 and 24 weeks
Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Measured: Baseline, 14 and 24 weeks
Compare toxicity/adverse events in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 24 weeks
Compare toxicity/adverse events in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 24 weeks
Measured: Baseline and 24 weeks
Compare patients acceptability in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Compare patients acceptability in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Measured: post 24 weeks
Compare PFS in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Compare PFS in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Measured: post 24 weeks
Compare health economics in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Compare health economics in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Measured: Baseline, 14 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startSep 2003
- Primary completion1 Jun 2011
- Study completion1 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single group
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Collaborators
- University of Leeds
- Responsible party
- Principal investigator, Cheryl Pugh, Medical Research Council
- Investigators
- Matthew T. Seymour, MA, MD, FRCP, Principal investigator, Cookridge HospitalGareth Griffiths, Study chair, Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070213
- Sponsor's protocol ID
- CDR0000330142
- Other IDs
- NCRI-FOCUS2, MRC-CR09, EU-20303
- Status last verified
- Sep 2021
- First submitted
- 3 Oct 2003
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seymour MT, Thompson LC, Wasan HS, Middleton G, Brewster AE, Shepherd SF, O'Mahony MS, Maughan TS, Parmar M, Langley RE; FOCUS2 Investigators; National Cancer Research Institute Colorectal Cancer Clinical Studies Group. Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): an open-label, randomised factorial trial. Lancet. 2011 May 21;377(9779):1749-59. doi: 10.1016/S0140-6736(11)60399-1. Epub 2011 May 11.
PubMed 21570111Seymour MT, Maughan TS, Wasan HS, et al.: Capecitabine (Cap) and oxaliplatin (Ox) in elderly and/or frail patients with metastatic colorectal cancer: the FOCUS2 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9030, 500s, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Treatment for Bowel Cancer: Making the Best Choices When a Milder Treatment is Needed
- ClinicalTrials.gov ID
- NCT00070213
- Acronym / sponsor ID
- CDR0000330142
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV rectal cancer, stage IV colon cancer, recurrent rectal cancer, recurrent colon cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- University of Leeds
- Study start
- Sep 2003
- Primary completion
- 1 Jun 2011 (actual)
- Study completion
- 1 Jun 2011 (actual)
- First posted
- 7 Oct 2003 (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.
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the progression-free survival of patients with metastatic colorectal adenocarcinoma treated with leucovorin calcium and fluorouracil with vs without oxaliplatin or capecitabine with vs without oxaliplatin.
- Compare the quality of life of patients treated with these fluorouracil-based vs capecitabine-based regimens.
Secondary
- Compare the failure-free and overall survival of patients treated with these regimens.
- Compare the toxic effects and adverse events associated with these regimens in these patients.
- Compare the limited health assessments of patients treated with these regimens.
- Compare the health economics associated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms and receive 12 weeks of therapy.
- Arm I (MdG regimen): Patients receive leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm II.
- Arm II (OxMdG regimen): Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study.
- Arm III (Cap regimen): Patients receive oral capecitabine twice daily on days 1-15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm IV.
- Arm IV (OxCap regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study.
All patients are then re-evaluated at least every 6 weeks and begin another 12 weeks of therapy at any evidence (e.g., clinical, radiological, or tumor marker) of disease progression. Patients with chemo-sensitive disease may repeat alternating 12-week therapy sessions and evaluation periods indefinitely.
Quality of life is assessed at baseline, at 12-14 weeks, at 24 weeks, and then every 3 months thereafter.
Patients are followed every 3 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 460 patients (115 per treatment arm) will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MdG (modified de Gramont) | Active comparator | Drug: FOLFOX regimen, Drug: fluorouracil, Drug: leucovorin calcium, Procedure: quality-of-life assessment2 weekly 5FU/FA schedule |
| OxMdG (80%) for 12 weeks | Experimental | Drug: FOLFOX regimen, Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatin, Procedure: quality-of-life assessmentMdG + oxaliplatin |
| Capcitabine | Experimental | Drug: capecitabine, Procedure: quality-of-life assessment |
| OxCap | Experimental | Drug: capecitabine, Drug: oxaliplatin, Procedure: quality-of-life assessment |
Who may qualify
- Ages
- 0 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| FOLFOX regimen | Drug | MdG (modified de Gramont), OxMdG (80%) for 12 weeks |
| capecitabine | Drug | Capcitabine, OxCap |
| fluorouracil | Drug | MdG (modified de Gramont), OxMdG (80%) for 12 weeks |
| leucovorin calcium | Drug | MdG (modified de Gramont), OxMdG (80%) for 12 weeks |
| oxaliplatin | Drug | OxCap, OxMdG (80%) for 12 weeks |
| quality-of-life assessment | Procedure or surgery | Capcitabine, MdG (modified de Gramont), OxCap, OxMdG (80%) for 12 weeks |
Primary outcome
Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr
Time frame: PFS
Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr
Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 14 weeks
Time frame: Baseline and 14 weeks
Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 14 weeks
10 secondary outcomes
Compare health assessment, including quality of life, in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap at baseline and 14 and 24 weeks
Time frame: Baseline, 14 and 24 weeks
Compare toxicity/adverse events in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Time frame: post 24 weeks
Compare overall failure-free survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Time frame: post 24 weeks
Compare overall survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Time frame: post 24 weeks
Compare health economics in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap
Time frame: Baseline, 14 and 24 weeks
Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Time frame: Baseline, 14 and 24 weeks
Compare toxicity/adverse events in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 24 weeks
Time frame: Baseline and 24 weeks
Compare patients acceptability in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Time frame: post 24 weeks
Compare PFS in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Time frame: post 24 weeks
Compare health economics in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap
Time frame: Baseline, 14 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Results publication: PubMed 21570111Seymour MT, Thompson LC, Wasan HS, Middleton G, Brewster AE, Shepherd SF, O'Mahony MS, Maughan TS, Parmar M, Langley RE; FOCUS2 Investigators; National Cancer Research Institute Colorectal Cancer Clinical Studies Group. Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): an open-label, randomised factorial trial. Lancet. 2011 May 21;377(9779):1749-59. doi: 10.1016/S0140-6736(11)60399-1. Epub 2011 May 11.
- Results publicationSeymour MT, Maughan TS, Wasan HS, et al.: Capecitabine (Cap) and oxaliplatin (Ox) in elderly and/or frail patients with metastatic colorectal cancer: the FOCUS2 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9030, 500s, 2007.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
Related trials for Colorectal Cancer
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
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Matthew T. Seymour, MA, MD, FRCP principal investigator
Cookridge Hospital
Gareth Griffiths study chair
Medical Research Council
4 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 FOLFOX regimen, capecitabine and fluorouracil in people with Colorectal Cancer, run by Medical Research Council at 4 sites in United Kingdom.
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: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr (time frame: PFS). 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 NCT00070213, which also lists 2 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 27 Sep 2021.