Metastatic Colorectal CancerPhase 3NCT02060669
Xeloda Maintenance Versus BSC in Metastatic Colorectal Cancer
A Phase 3 study testing Xeloda in people with Metastatic Colorectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Colorectal cancer (CRC) accounts for 10% to 15% of all cancers and is the second leading cause of cancer deaths in Western countries. Approximately half of all patients develop metastatic disease and become candidates for the palliative chemotherapy which has been proved to prolong survival and improve quality of life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Xeloda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2010to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented colorectal adenocarcinoma (chemo-naïve)
- Age over 18 years old
- Performance status (ECOG scale): 0-2
- Measurable or evaluable disease
- Adequate organ functions
- Life expectancy more than 3 months
- Patients should sign a written informed consent before study entry.
Who cannot join
- Tumor type other than adenocarcinoma
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, papillary thyroid carcinoma or prior malignancy treated more than 5 years ago without recurrence)
- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic colorectal cancer.
- Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
- Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
- Presence of CNS metastasis
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- Obvious peritoneal seeding or bowel obstruction disturbing oral intake
- Symptomatic peripheral neuropathy (NCI CTC v3.0 Grade I)
- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. Prior palliative surgical treatment of stage IV disease is permitted. The patient without measurable lesion(s) by operation or RFA is not eligible.
- Serious illness or medical conditions, as follows;congestive heart failure (NYHA class III or IV), unstable angina or myocardial infarction within the past 6 months, significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block,uncontrolled hypertension hepatic cirrhosis( above Child class B), interstitial pneumonia, pulmonary adenomatosis, psychiatric disorder that may interfere with and/or protocol compliance, unstable diabetes mellitus, uncontrolled ascites or pleural effusion active infection
- Receiving a concomitant treatment with drugs interacting with capecitabine or oxaliplatin, as follows;flucytosine, a fluorinated pyrimidine antifungal agent, phenytoin, warfarin etc.
- Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
- Pregnant or lactating woman
- Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Trial of XELOX (Xeloda/Oxaliplatin) Followed by Xeloda Maintenance Versus Best Supportive Care (BSC) in Metastatic Colorectal Cancer
Colorectal cancer (CRC) accounts for 10% to 15% of all cancers and is the second leading cause of cancer deaths in Western countries. Approximately half of all patients develop metastatic disease and become candidates for the palliative chemotherapy which has been proved to prolong survival and improve quality of life (QOL) in patients with metastatic CRC. The most active chemotherapy regiments include oxaliplatin or irinotecan combined with fluoropyrimidines.
With overall survival in metastatic CRC nowadays routinely around 2 years, the same intensity of therapy can hardly be maintained throughout the course of therapy. The continuum of care therefore mandates changes in therapy, with treatment breaks or phases of less-intensive maintenance therapy interspersed with periods of more-intensive therapy to control tumor progression. Thereby, chemo-holidays conceivably reduce the cumulative toxicities of chemotherapy, potentially prevent the unplanned, premature discontinuation of therapy, preserve the ability to administer further phases of therapy, potentially maximize the time on therapy, reduce cost, and could increase QOL for patients. Several trials have tested the influence of chemo-holidays on patient outcome, with various rules on when to stop which component of antitumor therapy as follows; 1) Completely stopping all therapeutic agents, giving patients a completely chemotherapy-free interval (OPTIMOX-2, GISCAD), or 2) Stopping only those agents associated with significant (cumulative) toxicity while continuing other agents as maintenance therapy (OPTIMOX-1, Combined Oxaliplatin Neurotoxicity Prevention Trial [CONcePT]).
Therefore, we'd like to test if capecitabine maintenance after 8 cycles of capecitabine combine with oxaliplatin (XELOX) could prolong progression-free survival without deterioration of QOL and toxicities in patients metastatic CRC.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Xeloda
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XelodaDrug
Xeloda
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | xeloda maintaenance Receives: Drug: Xeloda |
| Arm 2 | No intervention | best supprotive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: up to 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study start20 Jun 2010
- Primary completionMay 2014
- Study completionSep 2014
Why it stopped: others
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Joon Oh Park, Samsung Medical Center
- Investigators
- Joon Oh Park, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060669
- Sponsor's protocol ID
- 2010-02-047
- Status last verified
- Apr 2017
- First submitted
- 19 Jan 2012
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of XELOX (Xeloda/Oxaliplatin) Followed by Xeloda Maintenance Versus Best Supportive Care (BSC) in Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02060669
- Acronym / sponsor ID
- 2010-02-047
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: others
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 20 Jun 2010 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Feb 2014 (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.
Colorectal cancer (CRC) accounts for 10% to 15% of all cancers and is the second leading cause of cancer deaths in Western countries. Approximately half of all patients develop metastatic disease and become candidates for the palliative chemotherapy which has been proved to prolong survival and improve quality of life (QOL) in patients with metastatic CRC. The most active chemotherapy regiments include oxaliplatin or irinotecan combined with fluoropyrimidines.
With overall survival in metastatic CRC nowadays routinely around 2 years, the same intensity of therapy can hardly be maintained throughout the course of therapy. The continuum of care therefore mandates changes in therapy, with treatment breaks or phases of less-intensive maintenance therapy interspersed with periods of more-intensive therapy to control tumor progression. Thereby, chemo-holidays conceivably reduce the cumulative toxicities of chemotherapy, potentially prevent the unplanned, premature discontinuation of therapy, preserve the ability to administer further phases of therapy, potentially maximize the time on therapy, reduce cost, and could increase QOL for patients. Several trials have tested the influence of chemo-holidays on patient outcome, with various rules on when to stop which component of antitumor therapy as follows; 1) Completely stopping all therapeutic agents, giving patients a completely chemotherapy-free interval (OPTIMOX-2, GISCAD), or 2) Stopping only those agents associated with significant (cumulative) toxicity while continuing other agents as maintenance therapy (OPTIMOX-1, Combined Oxaliplatin Neurotoxicity Prevention Trial [CONcePT]).
Therefore, we'd like to test if capecitabine maintenance after 8 cycles of capecitabine combine with oxaliplatin (XELOX) could prolong progression-free survival without deterioration of QOL and toxicities in patients metastatic CRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Xelodaxeloda maintaenance |
| Arm 2 | No intervention | –best supprotive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically documented colorectal adenocarcinoma (chemo-naïve)
- Age over 18 years old
- Performance status (ECOG scale): 0-2
- Measurable or evaluable disease
- Adequate organ functions
Key exclusion criteria (16 listed)
- Tumor type other than adenocarcinoma
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, papillary thyroid carcinoma or prior malignancy treated more than 5 years ago without recurrence)
- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic colorectal cancer.
- Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
- Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
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 |
|---|---|---|
| XelodaXeloda | Drug | Arm 1 |
Primary outcome
Progression free survival
Time frame: up to 6weeks
Results and safety
The study was stopped early (reason given: others). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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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.
Joon Oh Park, M.D. principal investigator
Samsung Medical Center
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 Xeloda in people with Metastatic Colorectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 27 Apr 2017. 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 South Korea. 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 was stopped early (reason given: others). Results are not available in the source record.
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 (time frame: up to 6weeks). 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 27 Apr 2017.