Stage IV or Recurrent Carcinoma or SarcomaPhase 2NCT01898962
Definitive Therapy for Oligometastatic Solid Malignancies
A Phase 2 study testing Complete Surgical Removal, Stereotactic Radiosurgery and Ablative external beam radiation dose in people with Stage IV or Recurrent Carcinoma or Sarcoma, run by Rocky Mountain Cancer Centers at 4 sites in United States.
Trial summary
Patients with metastatic cancer are usually treated with systemic therapy (treating the entire body) with the assumption that any localized treatment of clinically apparent metastases would not impact survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV or Recurrent Carcinoma or Sarcoma
- What is being tested?
- Complete Surgical Removal, Stereotactic Radiosurgery and Ablative external beam radiation dose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2005to Dec 2018
- Phase
- Phase 2
- 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
- 4 or less distinct sites of active disease. Locoregional disease counts as one site
- All sites of disease can safely be encompassed by radiation fields to doses ≥ 45 Gy (biologic equivalent dose) and/or removed completely with surgery and/or completely ablated with other appropriate site-specific techniques.
- sufficient blood cell counts and adequate liver function
Who cannot join
- Hematologic malignancies
- Distinct sites of disease > 4
- Karnofsky Performance Status < 70
- Unexplained weight loss > 10 %
- HIV, chronic viral hepatitis, or any chronically active infection
- Life expectancy < 6 months for any reason
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012
Dennis Carter, MD
William Daniel, MD
- Recruiting
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, 80303
Andrew Antell, MD
Meera Patel, MD
- Recruiting
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, 80120
Charles Leonard, MD
Kathryn Howell, MD
- Recruiting
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, 80260
Robert LaPorte, MD
About this study
Official title: A Prospective Investigation of Definitive Targeted Therapy for Solid Malignancies With Oligometastases
Patients with metastatic cancer are usually treated with systemic therapy (treating the entire body) with the assumption that any localized treatment of clinically apparent metastases would not impact survival. In the setting of increasingly effective systemic therapy and limited metastatic disease, aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival.
Read the detailed description
Up to recently it has been assumed that in the setting of metastatic solid tumors, locoregional control of clinically apparent metastases does not substantially impact survival due to undetectable micrometastic (clinically not visualized) disease that ultimately lead to treatment failure/progression. However, as more advanced systemic therapy continue to improve control of micrometastatic disease, failures at the original sites of disease remain common. Furthermore, some studies have shown locoregional treatment of limited clinical metastases to actually improve survival. Therefore, the investigators hypothesize that aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival or alter the course of the disease in some patients with limited metastatic disease.
- Being tested
- Complete Surgical Removal, Stereotactic Radiosurgery, Ablative external beam radiation dose, Subtotal surgical removal plus ablative radiation dose, Radioembolization
- Keywords
- Oligometastases, Metastatic cancer, Stereotactic radiosurgery
- Medical subject headings
- Recurrence, Sarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Surgical RemovalProcedure or surgery
Stereotactic RadiosurgeryRadiation
Also called Stereotactic radiosurgery (SRS) for extracranial metastases are also known as streotactic body radiotherapy (SBRT)
Ablative external beam radiation doseRadiation
Also called External Beam Radiation Therapy (EBRT) with prescribed doses ≥ 45 Gy (biologic equivalent dose)
Subtotal surgical removal plus ablative radiation doseProcedure or surgery
Also called tumors surgically debulked with residual disease or close/positive margins followed by ablative radiation doses
Residual tumor or close/positive margins should be followed by ablative radiation doses (by either stereotactic radiosurgery or convential EBRT) to constitute definitive locoregional treatment
RadioembolizationRadiation
Also called Yttrium-90 (Y-90) microspheres, Y-90 radioembolization, SIR-spheres, TheraSphere
radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques
| Study group | Role | What they receive |
|---|---|---|
| Definitive locoregional treatment | Experimental | All sites of active disease should be treated definitively (with one of the interventions listed below). Definitive treatment does not have to be the same for all sites of disease. Receives: Procedure: Complete Surgical Removal; Radiation: Stereotactic Radiosurgery; Radiation: Ablative external beam radiation dose; Procedure: Subtotal surgical removal plus ablative radiation dose; Radiation: Radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Overall and disease-specific survival, to be assessed at 1, 3, and 5 years.
Measured: 5 years
Secondary outcomes (3)
Progression free survival (PFS)
Time to first progression of disease (regardless of location)
Measured: 5 years
Locoregional disease control
Time to first progression within definitively treated areas
Measured: 5 years
Toxicity
Including grade 2+ toxicity attributable to localized study treatment as well as to systemic therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startDec 2005
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV or Recurrent Carcinoma or SarcomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain Cancer Centers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennise Carter, MD, Principal investigator, Rocky Mountain Cancer Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898962
- Sponsor's protocol ID
- Carter 2005-01
- Other IDs
- 1073869
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Investigation of Definitive Targeted Therapy for Solid Malignancies With Oligometastases
- ClinicalTrials.gov ID
- NCT01898962
- Acronym / sponsor ID
- Carter 2005-01
- Keywords
- Oligometastases, Metastatic cancer, Stereotactic radiosurgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Rocky Mountain Cancer CentersUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Jul 2013 (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.
Patients with metastatic cancer are usually treated with systemic therapy (treating the entire body) with the assumption that any localized treatment of clinically apparent metastases would not impact survival. In the setting of increasingly effective systemic therapy and limited metastatic disease, aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival.
Detailed description
Up to recently it has been assumed that in the setting of metastatic solid tumors, locoregional control of clinically apparent metastases does not substantially impact survival due to undetectable micrometastic (clinically not visualized) disease that ultimately lead to treatment failure/progression. However, as more advanced systemic therapy continue to improve control of micrometastatic disease, failures at the original sites of disease remain common. Furthermore, some studies have shown locoregional treatment of limited clinical metastases to actually improve survival. Therefore, the investigators hypothesize that aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival or alter the course of the disease in some patients with limited metastatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Definitive locoregional treatment | Experimental | Procedure: Complete Surgical Removal, Radiation: Stereotactic Radiosurgery, Radiation: Ablative external beam radiation dose, Procedure: Subtotal surgical removal plus ablative radiation dose, Radiation: RadioembolizationAll sites of active disease should be treated definitively (with one of the interventions listed below). Definitive treatment does not have to be the same for all sites of disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 4 or less distinct sites of active disease. Locoregional disease counts as one site
- All sites of disease can safely be encompassed by radiation fields to doses ≥ 45 Gy (biologic equivalent dose) and/or removed completely with surgery and/or completely ablated with other appropriate site-specific techniques.
- sufficient blood cell counts and adequate liver function
Key exclusion criteria (6 listed)
- Hematologic malignancies
- Distinct sites of disease > 4
- Karnofsky Performance Status < 70
- Unexplained weight loss > 10 %
- HIV, chronic viral hepatitis, or any chronically active infection
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 |
|---|---|---|
| Complete Surgical Removal | Procedure or surgery | Definitive locoregional treatment |
| Stereotactic RadiosurgeryAlso: Stereotactic radiosurgery (SRS) for extracranial metastases are also known as streotactic body radiotherapy (SBRT) | Radiation | Definitive locoregional treatment |
| Ablative external beam radiation doseAlso: External Beam Radiation Therapy (EBRT) with prescribed doses ≥ 45 Gy (biologic equivalent dose) | Radiation | Definitive locoregional treatment |
| Subtotal surgical removal plus ablative radiation doseAlso: tumors surgically debulked with residual disease or close/positive margins followed by ablative radiation dosesResidual tumor or close/positive margins should be followed by ablative radiation doses (by either stereotactic radiosurgery or convential EBRT) to constitute definitive locoregional treatment | Procedure or surgery | Definitive locoregional treatment |
| RadioembolizationAlso: Yttrium-90 (Y-90) microspheres, Y-90 radioembolization, SIR-spheres, TheraSphereradioembolization of the liver with Y-90 microspheres or other site-appropriate techniques | Radiation | Definitive locoregional treatment |
Primary outcome
Survival
Time frame: 5 years
Overall and disease-specific survival, to be assessed at 1, 3, and 5 years.
3 secondary outcomes
Progression free survival (PFS)
Time frame: 5 years
Locoregional disease control
Time frame: 5 years
Toxicity
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.
Dennise Carter, MD principal investigator
Rocky Mountain Cancer Centers
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Complete Surgical Removal, Stereotactic Radiosurgery and Ablative external beam radiation dose in people with Stage IV or Recurrent Carcinoma or Sarcoma, run by Rocky Mountain Cancer Centers at 4 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?
The sponsor lists 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Jul 2013. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Lei, BS (303-418-7607, rachel.lei@usoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 5 years). 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 Jul 2013.