Stomach CancerNCT01010334
Comparison of Standard of Care or Treatment on Protocol
A study of Stomach Cancer and Esophageal Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial summary
Patient will choose to either receive the standard of care according to National Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. The selection of the arm will be at physician discretion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer, Esophageal Cancer, Bladder Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jul 2011
- Phase
- Interventional
- 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
- Patients must have a cancer requiring chemotherapy or radiotherapy
Who cannot join
- Inability to comply with study and/or follow-up procedures
- Any contraindication per the FDA notice to the selected drugs
- Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87106
About this study
Official title: Randomized Study of Patients (Patient Choice) Who Are Not Eligible for Variations of Standard of Care Protocols When Treated Either on Best Standard of Care Pathways or Per a Protocol Arm That They Failed to Enroll to
Patient will choose to either receive the standard of care according to National Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. The selection of the arm will be at physician discretion.
Read the detailed description
All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy or to one of the arms of the protocol they fail to enroll in, as determined by the treating physician.
- Conditions
- Stomach Cancer, Esophageal Cancer, Bladder Cancer, Skin Cancer, Lung Cancer, Uterine Cancer
- Being tested
- standard of care
- Keywords
- INST 0813, Standard of Care
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Urinary Bladder Neoplasms, Skin Neoplasms, Lung Neoplasms, Uterine Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careOther
Also called Standard of Care therapy (disease site based), VARIIOUS experimental therapies (based on protocol for which pt failed eligibility)
All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy, OR to one of the arms of the protocol they failed to enroll in, as determined by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Standard of Care Treatment Receives: Other: standard of care |
| Arm 2 | Experimental | Treatment Arm of a separate protocol (physician discretion) Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of courses delivered (relative dose intensity for adjuvant studies)
Measured: 6 months
Secondary outcomes (5)
Response rate
Measured: 6 months
Progression- or disease-free survival (for metastatic disease)
Measured: 6 months
Overall survival
Measured: 6 months
Describe all adverse events of grade > 3 and Serious Adverse Events
Measured: 6 months
Measure quality of life using a FACT G tool, before and at best response and at the end of the treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: PI deparature and very low (\<2%) accrual rate.(No results required)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach 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 N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Verschraegen, MD, Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010334
- Sponsor's protocol ID
- INST 0813
- Other IDs
- NCI-2011-02680
- Status last verified
- Aug 2013
- First submitted
- 24 Jul 2009
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Patients (Patient Choice) Who Are Not Eligible for Variations of Standard of Care Protocols When Treated Either on Best Standard of Care Pathways or Per a Protocol Arm That They Failed to Enroll to
- ClinicalTrials.gov ID
- NCT01010334
- Acronym / sponsor ID
- INST 0813
- Conditions
- Stomach Cancer, Esophageal Cancer, Bladder Cancer, Skin Cancer, Lung Cancer, Uterine Cancer
- Keywords
- INST 0813, Standard of Care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI deparature and very low (\<2%) accrual rate.(No results required)
- Enrolment
- 13 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Nov 2009 (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.
Patient will choose to either receive the standard of care according to National Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. The selection of the arm will be at physician discretion.
Detailed description
All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy or to one of the arms of the protocol they fail to enroll in, as determined by the treating physician.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Other: standard of careStandard of Care Treatment |
| Arm 2 | Experimental | Other: standard of careTreatment Arm of a separate protocol (physician discretion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have a cancer requiring chemotherapy or radiotherapy
Key exclusion criteria (3 listed)
- Inability to comply with study and/or follow-up procedures
- Any contraindication per the FDA notice to the selected drugs
- Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential
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 |
|---|---|---|
| standard of careAlso: Standard of Care therapy (disease site based), VARIIOUS experimental therapies (based on protocol for which pt failed eligibility)All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy, OR to one of the arms of the protocol they failed to enroll in, as determined by the treating physician. | Other | Arm 1, Arm 2 |
Primary outcome
Number of courses delivered (relative dose intensity for adjuvant studies)
Time frame: 6 months
5 secondary outcomes
Response rate
Time frame: 6 months
Progression- or disease-free survival (for metastatic disease)
Time frame: 6 months
Overall survival
Time frame: 6 months
Describe all adverse events of grade > 3 and Serious Adverse Events
Time frame: 6 months
Measure quality of life using a FACT G tool, before and at best response and at the end of the treatment
Time frame: 6 months
Results and safety
The study was stopped early (reason given: PI deparature and very low (\<2%) accrual rate.(No results required)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
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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.
Claire Verschraegen, MD principal investigator
University of New Mexico Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stomach Cancer and Esophageal Cancer, run by New Mexico Cancer Research Alliance at 1 site 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?
The sponsor lists 1 inclusion and 3 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 14 Aug 2013. 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 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.
Are results available for this study?
The study was stopped early (reason given: PI deparature and very low (\<2%) accrual rate.(No results required)). 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?
Number of courses delivered (relative dose intensity for adjuvant studies) (time frame: 6 months). 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 14 Aug 2013.