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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 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment
Cancer Patients Receiving Stereotactic Body RTX Radiation: SBRT

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: UTSW SBRT Prospective Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
Actual Study Start Date : May 28, 2014
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
OLIGOMETASTATIC ARM
SBRT to Oligometastases
Radiation: SBRT
SBRT to Oligometastases
Other Name: Stereotactic body radiation therapy

CONSOLIDATION ARM
SBRT as Consolidation to Residual Disease
Radiation: SBRT
SBRT to Oligometastases
Other Name: Stereotactic body radiation therapy

NORTON-SIMON ARM
SBRT to Debulk Gross Disease
Radiation: SBRT
SBRT to Oligometastases
Other Name: Stereotactic body radiation therapy

RE-IRRADIATION ARM Radiation: SBRT
SBRT to Oligometastases
Other Name: Stereotactic body radiation therapy




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Loco-regional control [ Time Frame: 5 years ]
    Loco-regional control in sites treated via SBRT in the four treatment categories.

  2. overall survival [ Time Frame: 5 years ]
    To evaluate overall survival among patients in the four treatment categories.

  3. Number of patients with toxicities [ Time Frame: 2 years ]
    To evaluate the safety of SBRT in the four treatment categories: toxicities review


Biospecimen Retention:   Samples With DNA
Tissue Procurement


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients receive SBRT
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170181


Contacts
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Contact: Sarah Hardee, MS 214-645-8525 sarah.hardee@UTSouthwestern.edu
Contact: Kajal Desai, MS 2146458525 kajal.desai@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75239
Principal Investigator: Asal Rahimi, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Asal Rahimi, MD UTSW
Additional Information:

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02170181    
Other Study ID Numbers: STU 012014-039
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: May 2020
Keywords provided by University of Texas Southwestern Medical Center:
SBRT
prostate cancer
lung cancer
bladder cancer
kidney cancer
oligometastatic disease