Eligibility Details:
Inclusion Criteria:
1. Age ≥18 years.
2. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A section 24).
3. Patients must have a malignancy that is metastatic or unresectable (for surgical or
medical reasons).
4. Typical retroperitoneal pain syndrome (pain that radiates from the lower back to the
upper abdomen, belt like distribution).
5. Uncontrolled pain at recruitment, defined as >=5 on 11 point BPI scale despite
analgesic use.
6. Anatomical involvement of the celiac plexus, as defined by at least one of the
following:
1. Any Pancreatic cancer
2. Any other cancer that on imaging demonstrates either: gross involvement of the
celiac blood vessels or celiac plexus on imaging OR haziness around the celiac
blood vessels, that typically implies tumor engulfment.
7. Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old. The CT
simulation performed as part of the protocol will be considered sufficient.
8. Prior chemotherapy or biological treatment is allowed, but any active oncological
treatment should be stopped at least 6 days prior to radiation and renewed at least 6
days following radiation. For trastuzumab emtansine a 14 break prior to, and a 6 day
break post-therapy is required. Hormonal treatments (e.g. tamoxifen, androgen
ablation, androgen antagonists, aromatase inhibitors), and bone-strengthening agents
(e.g. bisphosphonates, anti-RANKL antibody denosumab) may be continued during the
radiation treatment, and do not need to be interrupted.
9. Willingness to attend 3- and 6- week follow-up visits, and participate in telephone
follow-up thereafter.
10. Radiation is known to be teratogenic, 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 and for the duration of study participation. Should a
woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician immediately. Men
treated or enrolled on this protocol must also agree to use adequate contraception
prior to the study, for the duration of study participation, and 4 months after
completion of therapy.
11. Ability to understand and the willingness to sign a written informed consent document.
12. Before patient registration, written informed consent must be provided.
Exclusion Criteria:
1. Patients under 18 years of age
2. Patients who are well balanced in terms of pain control
3. Patients with life expectancy <8 weeks as defined by the primary oncologist.
4. Known serum albumin <2.4 (does not need to be especially tested if unknown).*
5. Known lymphopenia defined as <12% of white blood count (does not need to be especially
tested if unknown).*
6. Altered mental status (defined as change in brain function from baseline including
confusion, drowsiness, delirium, dementia or coma)*
7. Leptomeningeal spread*
8. Current or previous spinal cord compression*
9. Significant comorbidities (this is left to physicians' discretion. Guidance provided
below section 8.4. As an example, patients with metastatic cancer, in the context of
combined impaired renal and hepatic function are expected to have a poor survival)*
10. Patients with ECOG Performance status 3 or 4*
11. Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before
until 1 week following radiotherapy.
12. Previous radiotherapy to upper abdomen.
13. Conditions associated with increased side effects to radiotherapy (Inflammatory bowel
disease, scleroderma for example).
14. Patients who have not recovered from the acute adverse events due to prior anti-cancer
therapy (however peripheral neuropathy and other chronic side effects of anti-cancer
therapy are not exclusion criteria).
15. 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.
16. Special populations: pregnant women, prisoners, patients with major psychiatric
illnesses.
17. Unwilling or unable to attend 3-week and 6-week post treatment assessments.
- these factors are all associated with a very poor prognosis. 40 ------ Nb There
are criteria that exclude patients from performing the six-minute walk test (see
section 29). These patients may nonetheless participate in the protocol and
undergo celiac axis radiosurgery.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-yes
