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Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation

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ClinicalTrials.gov Identifier: NCT02170181
Recruitment Status : Recruiting
First Posted : June 23, 2014
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Asal Rahimi, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date June 13, 2014
First Posted Date June 23, 2014
Last Update Posted Date August 30, 2021
Actual Study Start Date May 28, 2014
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 20, 2014)
  • Loco-regional control [ Time Frame: 5 years ]
    Loco-regional control in sites treated via SBRT in the four treatment categories.
  • overall survival [ Time Frame: 5 years ]
    To evaluate overall survival among patients in the four treatment categories.
  • Number of patients with toxicities [ Time Frame: 2 years ]
    To evaluate the safety of SBRT in the four treatment categories: toxicities review
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
Official Title UTSW SBRT Prospective Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
Brief 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. 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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Tissue Procurement
Sampling Method Non-Probability Sample
Study Population patients receive SBRT
Condition Cancer Patients Receiving Stereotactic Body RTX
Intervention Radiation: SBRT
SBRT to Oligometastases
Other Name: Stereotactic body radiation therapy
Study Groups/Cohorts
  • OLIGOMETASTATIC ARM
    SBRT to Oligometastases
    Intervention: Radiation: SBRT
  • CONSOLIDATION ARM
    SBRT as Consolidation to Residual Disease
    Intervention: Radiation: SBRT
  • NORTON-SIMON ARM
    SBRT to Debulk Gross Disease
    Intervention: Radiation: SBRT
  • RE-IRRADIATION ARM
    Intervention: Radiation: SBRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 20, 2014)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Pathologically confirmed solid tumor malignancies which are locally advanced or metastatic.
  2. Able to safely receive intended protocol defined SBRT dose.
  3. For oligometastatic category, patients can have up to 6 sites of active extracranial disease amenable to SBRT with a maximum of 7 cm diameter
  4. Must have a CT C/A/P, or PET/CT scan within 8 weeks of enrollment.
  5. Age ≥ 18 years.
  6. Karnofsky performance status of 70 or higher, or ECOG < 2
  7. 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).
  8. Agreeable and willing to participate in expected protocol defined follow-up.
  9. Ability to understand and the willingness to sign a written informed consent.
  10. Registry participation does not exclude participation in clinical trials.

Exclusion Criteria:

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.

4 Patients should not be undergoing concurrent chemotherapy.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sarah Hardee, MS 214-645-8525 sarah.hardee@UTSouthwestern.edu
Contact: Kajal Desai, MS 2146458525 kajal.desai@utsouthwestern.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02170181
Other Study ID Numbers STU 012014-039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Asal Rahimi, University of Texas Southwestern Medical Center
Study Sponsor University of Texas Southwestern Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Asal Rahimi, MD UTSW
PRS Account University of Texas Southwestern Medical Center
Verification Date August 2021