Cancer Patients Receiving Stereotactic Body RTXNCT02170181
Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
An observational study of Cancer Patients Receiving Stereotactic Body RTX, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This prospective protocol will enroll patients with pathologically confirmed solid malignancies who receive stereotactic body radiation therapy (SBRT) for oligometastases, for consolidation after systemic therapy, prior to systemic therapy for the purposes of debulking, or in the re-irradiation setting. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer Patients Receiving Stereotactic Body RTX
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2014to Aug 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients receive SBRT
Who may be able to join
- Pathologically confirmed solid tumor malignancies which are locally advanced or metastatic.
- Able to safely receive intended protocol defined SBRT dose.
- For oligometastatic category, patients can have up to 6 sites of active extracranial disease amenable to SBRT with a maximum of 7 cm diameter
- Must have a CT C/A/P, or PET/CT scan within 12 weeks of enrollment.
- Age ≥ 18 years.
- Karnofsky performance status of 70 or higher, or ECOG < 2
Show all 14Show fewer
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- 7.1 a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Negative urine or serum pregnancy test for women of child-bearing potential
- Agreeable and willing to participate in expected protocol defined follow-up.
- Ability to understand and the willingness to sign a written informed consent.
- Registry participation does not exclude participation in clinical trials.
Who cannot join
- 1 Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
- 2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- 3 Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75239
About this study
Official title: UTSW SBRT Prospective Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
This prospective protocol will enroll patients with pathologically confirmed solid malignancies who receive stereotactic body radiation therapy (SBRT) for oligometastases, for consolidation after systemic therapy, prior to systemic therapy for the purposes of debulking, or in the re-irradiation setting. Increasing use of SBRT off of clinical trials in patients with malignancies of all histologies is being utilized in these settings. However, individualized outcomes and characteristics of treatments are not prospectively followed and not well documented. By instituting a registry of patients receiving SBRT in these settings it will be possible to determine trends in patterns of care and outcomes for refinement and justification of this treatment.
Read the detailed description
Patients will be grouped into one of four treatment arms. Treatment intent must be specified at the time of registration.
OLIGOMETASTATIC ARM- The first treatment arm will be for patients with oligometastatic disease, which will be defined as a treatment with curative intent to less than or equal to six sites of disease on initial presentation of metastatic disease or within the context of the initial combined modality treatment regimen (e.g., after a chemotherapy or surgical phase of therapy). Patients in this treatment arm will receive a definitive, ablative dose of radiation intended to eradicate all residual gross tumor of "all" sites of disease. A variety of acceptable ablative fractionation schemes with variable ability to prevent normal tissue toxicity will be allowed. Further planned systemic therapy or surgery does not eliminate stratification into this group so long as the overall intent is curative.
CONSOLIDATION ARM- The second treatment arm will be for consolidation following systemic therapy. This approach is akin to the experience with consolidation with radiation with conventional radiation after systemic therapy for tumors like bulky lymphomas, etc. In this context, treatment will be directed towards PET-avid residual disease assuming them to harbor residual active disease or disease more resistant to systemic therapy. The treatment doses will be sub-ablative yet will still maintain radiobiologic potency for local control with the option in the future for further systemic therapy.
NORTON-SIMON ARM- The third treatment arm will enroll patients prior to receiving systemic therapy who require initial debulking of gross disease to enhance chemotherapy efficacy per the Norton-Simon hypothesis. (Patients who initially receive systemic therapy, with gross residual disease in less than or equal to 6 sites of disease, who then receive SBRT with planned further systemic therapy (targeted or cytotoxic) immediately following SBRT will be enrolled onto this arm)
RE-IRRADIATION ARM- The fourth treatment arm will enroll patients if they have had prior irradiation and suffered disease recurrence or failure within a previously irradiated volume. Prior irradiation can consist of external beam irradiation- conventional treatment, hypofractionated treatment, stereotactic radiation, or even brachytherapy
- Being tested
- SBRT
- Keywords
- SBRT, prostate cancer, lung cancer, bladder cancer, kidney cancer, oligometastatic disease
- Medical subject headings
- Prostatic Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called Stereotactic body radiation therapy
SBRT to Oligometastases
| Study group | Role | What they receive |
|---|---|---|
| OLIGOMETASTATIC ARM | SBRT to Oligometastases Receives: Radiation: SBRT | |
| CONSOLIDATION ARM | SBRT as Consolidation to Residual Disease Receives: Radiation: SBRT | |
| NORTON-SIMON ARM | SBRT to Debulk Gross Disease Receives: Radiation: SBRT | |
| RE-IRRADIATION ARM | Not described Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
patterns of care
Prospectively enroll patients to one of four treatment categories who are to receive SBRT onto a registry to define patterns of care:
Group 1: Oligometastatic disease- all radiologic suspicious areas for viable disease to be treated
Group 2: Consolidation Therapy - only PET avid or progressive disease
Group 3: Norton-Simon Arm - SBRT prior to initial of planned further systemic therapy
Group 4: Re-Irradiation Arm-recurrence or failure within a previously irradiated volume.
Measured: 5 years
Secondary outcomes (3)
Loco-regional control
Loco-regional control in sites treated via SBRT in the four treatment categories.
Measured: 5 years
overall survival
To evaluate overall survival among patients in the four treatment categories.
Measured: 5 years
Number of patients with toxicities
To evaluate the safety of SBRT in the four treatment categories: toxicities review
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 posted23 Jun 2014 (estimated)
- Study start28 May 2014
- Primary completionAug 2025
- Study completionAug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients Receiving Stereotactic Body RTXStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asal Rahimi, University of Texas Southwestern Medical Center
- Investigators
- Asal Rahimi, MD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170181
- Sponsor's protocol ID
- STU 012014-039
- Status last verified
- Sep 2025
- First submitted
- 13 Jun 2014
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UTSW SBRT Prospective Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
- ClinicalTrials.gov ID
- NCT02170181
- Acronym / sponsor ID
- STU 012014-039
- Keywords
- SBRT, prostate cancer, lung cancer, bladder cancer, kidney cancer, oligometastatic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 28 May 2014 (actual)
- Primary completion
- Aug 2025 (actual)
- Study completion
- Aug 2025 (actual)
- First posted
- 23 Jun 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.
This prospective protocol will enroll patients with pathologically confirmed solid malignancies who receive stereotactic body radiation therapy (SBRT) for oligometastases, for consolidation after systemic therapy, prior to systemic therapy for the purposes of debulking, or in the re-irradiation setting. Increasing use of SBRT off of clinical trials in patients with malignancies of all histologies is being utilized in these settings. However, individualized outcomes and characteristics of treatments are not prospectively followed and not well documented. By instituting a registry of patients receiving SBRT in these settings it will be possible to determine trends in patterns of care and outcomes for refinement and justification of this treatment.
Detailed description
Patients will be grouped into one of four treatment arms. Treatment intent must be specified at the time of registration.
OLIGOMETASTATIC ARM- The first treatment arm will be for patients with oligometastatic disease, which will be defined as a treatment with curative intent to less than or equal to six sites of disease on initial presentation of metastatic disease or within the context of the initial combined modality treatment regimen (e.g., after a chemotherapy or surgical phase of therapy). Patients in this treatment arm will receive a definitive, ablative dose of radiation intended to eradicate all residual gross tumor of "all" sites of disease. A variety of acceptable ablative fractionation schemes with variable ability to prevent normal tissue toxicity will be allowed. Further planned systemic therapy or surgery does not eliminate stratification into this group so long as the overall intent is curative.
CONSOLIDATION ARM- The second treatment arm will be for consolidation following systemic therapy. This approach is akin to the experience with consolidation with radiation with conventional radiation after systemic therapy for tumors like bulky lymphomas, etc. In this context, treatment will be directed towards PET-avid residual disease assuming them to harbor residual active disease or disease more resistant to systemic therapy. The treatment doses will be sub-ablative yet will still maintain radiobiologic potency for local control with the option in the future for further systemic therapy.
NORTON-SIMON ARM- The third treatment arm will enroll patients prior to receiving systemic therapy who require initial debulking of gross disease to enhance chemotherapy efficacy per the Norton-Simon hypothesis. (Patients who initially receive systemic therapy, with gross residual disease in less than or equal to 6 sites of disease, who then receive SBRT with planned further systemic therapy (targeted or cytotoxic) immediately following SBRT will be enrolled onto this arm)
RE-IRRADIATION ARM- The fourth treatment arm will enroll patients if they have had prior irradiation and suffered disease recurrence or failure within a previously irradiated volume. Prior irradiation can consist of external beam irradiation- conventional treatment, hypofractionated treatment, stereotactic radiation, or even brachytherapy
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OLIGOMETASTATIC ARM | – | Radiation: SBRTSBRT to Oligometastases |
| CONSOLIDATION ARM | – | Radiation: SBRTSBRT as Consolidation to Residual Disease |
| NORTON-SIMON ARM | – | Radiation: SBRTSBRT to Debulk Gross Disease |
| RE-IRRADIATION ARM | – | Radiation: SBRT |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients receive SBRT
Key inclusion criteria (14 listed)
- Pathologically confirmed solid tumor malignancies which are locally advanced or metastatic.
- Able to safely receive intended protocol defined SBRT dose.
- For oligometastatic category, patients can have up to 6 sites of active extracranial disease amenable to SBRT with a maximum of 7 cm diameter
- Must have a CT C/A/P, or PET/CT scan within 12 weeks of enrollment.
- Age ≥ 18 years.
Key exclusion criteria (3 listed)
- 1 Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
- 2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- 3 Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
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 |
|---|---|---|
| SBRTAlso: Stereotactic body radiation therapySBRT to Oligometastases | Radiation | CONSOLIDATION ARM, NORTON-SIMON ARM, OLIGOMETASTATIC ARM, RE-IRRADIATION ARM |
Primary outcome
patterns of care
Time frame: 5 years
Prospectively enroll patients to one of four treatment categories who are to receive SBRT onto a registry to define patterns of care: Group 1: Oligometastatic disease- all radiologic suspicious areas for viable disease to be treated Group 2: Consolidation Therapy - only PET avid or progressive disease Group 3: Norton-Simon Arm - SBRT prior to initial of planned further systemic therapy Group 4: Re-Irradiation Arm-recurrence or failure within a previously irradiated volume.
3 secondary outcomes
Loco-regional control
Time frame: 5 years
overall survival
Time frame: 5 years
Number of patients with toxicities
Time frame: 5 years
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 17 Sep 2025.
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.
Asal Rahimi, MD principal investigator
UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients Receiving Stereotactic Body RTX, run by University of Texas Southwestern Medical Center 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 14 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: finished, as of the sponsor's last update on 17 Sep 2025. 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 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?
patterns of care (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 17 Sep 2025.