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.
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
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||May 28, 2014||Observational [Patient Registry]|
Primary Outcome 1 - Measure: patterns of care
Primary Outcome 1 - Time Frame: 5 years
1. Pathologically confirmed solid tumor malignancies which are locally advanced or
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.
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
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.
Minimum Age: 18 Years
Maximum Age: 99 Years
Healthy Volunteers: No
Name: Asal Rahimi, MD
Role: Principal Investigator