Metastatic or Recurrent Lesions in the Pelvis, Metastatic or Recurrent Lesions in the Spine
Conditions
Keywords
radiation therapy, HDR brachytherapy, Ir-192 high dose rate, 12-260
Brief summary
The purpose of this study is to see if using a form of imaging during surgery helps the doctors to guide the placement of radiation catheters more accurately. This method, called image-guided surgical navigation may allow the doctors to deliver radiation to the tumor that the patient needs and decrease the amount of radiation delivered to the nearby areas.
Interventions
RADIATIONIr-192 high dose rate (HDR)
Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologic proof of a malignancy suitable for radiation therapy. * Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equine, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration. * If repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible. * If the total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals 2. \[Rades 2005, Nieder 2005, Sahgal 2012\] * KPS ≥ 60 * Age ≥ 18 years old
Exclusion criteria
* Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria. * Patients with kyphoplasty cement or hardware that would preclude effective catheter placement. * Patients with paraspinal extension of disease with visceral involvement. * Abnormal complete blood count. Any of the following: * Platelet count \< 75,000/ml * Hb level \< 9gm/dl * WBC \< 3.5/ml * Abnormal coagulation profile: INR \> 2.5 and/or PTT \> 80 * Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded. * Contraindications to general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Radiation Dose | 1 year | Verify feasibility of HDF treatment of spinal and/or pelvic lesions using catheters placed under image-guided navigational techniques, to provide improved dosimetric coverage of lesions such that Cord/Cauda Dmax of \<8 Gy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Grade 3 of Higher Toxicities | 1 year | For previously irradiated lesions of the spine and/or pelvis, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 NCI CTCAE v 4.0 toxicity that is at least possibly related to treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ir-192 High Dose Rate (HDR) This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.
Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Ir-192 High Dose Rate (HDR) |
|---|---|
| Age, Continuous | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 3 |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Maximum Radiation Dose
Verify feasibility of HDF treatment of spinal and/or pelvic lesions using catheters placed under image-guided navigational techniques, to provide improved dosimetric coverage of lesions such that Cord/Cauda Dmax of \<8 Gy
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ir-192 High Dose Rate (HDR) | Maximum Radiation Dose | 7 cord/cauda max dose in Gy |
Secondary
Number of Grade 3 of Higher Toxicities
For previously irradiated lesions of the spine and/or pelvis, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 NCI CTCAE v 4.0 toxicity that is at least possibly related to treatment
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ir-192 High Dose Rate (HDR) | Number of Grade 3 of Higher Toxicities | 0 brachytherapy related complications |