Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy

CTCs measurements will be taken pre- and post-RT treatment. CTCs measurements will also be
taken during treatment. The CTCs measurements from this study will provide essential
information for the power and sample size considerations for future translational studies,
particularly for those looking to identify biomarkers possibly associated with CTCs and tumor
response activity after XRT, and to adequately power more formal statistical comparisons of
important associations between CTCs and patient characteristics and outcomes.

Inclusion Criteria:

- Histologically confirmed cancer, fitting one of the following cohorts: locally
advanced head and neck cancer but no distant metastasis scheduled to receive
radiotherapy to the head and neck region with or without chemotherapy/targeted therapy
(palliative or curative intent); locally advanced cervical cancer without distant
metastasis scheduled for radiotherapy to the pelvic region with or without
chemotherapy/targeted therapy (palliative or curative intent); Stage I to III
non-small cell lung cancer, without distant metastasis, scheduled to receive
stereotactic body radiotherapy for early stage lung disease and/or external beam
radiotherapy for locally advanced lung disease, with or without concurrent/sequential
chemotherapy and/or targeted therapy (curative intent); metastatic prostate cancer
scheduled for palliative radiotherapy, or biochemically recurrent prostate cancer
following radical prostatectomy; scheduled for salvage prostatic fossa radiotherapy,
with or without androgen deprivation; locally advanced rectal cancer (no distant
metastasis) scheduled to receive neoadjuvant chemoradiotherapy (curative intent);
oligometastatic cancer, defined as any solid malignancy with< 5 measurable sites of
metastatic disease, limited to a maximum of 3 anatomic organ systems, excluding the
primary tumor and regional lymph nodes. At least 1 site of metastatic disease, but as
many as all 5 sites, in addition to the primary tumor and regional lymph nodes, is
amenable to local ablative therapy with external beam radiation, stereotactic cranial
radiosurgery (SRS) or stereotactic body radiotherapy (SBRT). Treatment will be guided
by multi-disciplinary evaluation and may also include surgery, chemotherapy or target
agents at the discretion of the primary oncologists. Patients may present with
oligometastatic disease or have oligometastatic disease recurrence after definitive
therapy for localized disease; Melanoma or metastatic NSCLC scheduled to receive
ipilimumab, nivolumab, and/or pembrolizumab.; Locally advanced head and neck cancer
(HNSCC) scheduled to receive induction chemotherapy followed by radiotherapy.

- Scheduled to initiate radiation for management of their disease, and schedule
accommodates blood sample collection prior to radiation

- Male and female of ≥18 years of age

- Male and female patients capable of reproduction must agree to use medically
acceptable methods of contraception, such as an intra-uterine device, diaphragm with
spermicide, condom with spermicide, or abstinence during radiation therapy. Inclusion
of females of childbearing potential requires a negative pregnancy test within 14 days
prior to study initiation (part of standard of care in radiation oncology).

- Written informed consent obtained and signed

- Able to have blood collection without excessive difficulty

Exclusion Criteria:

- Patient unwilling or unable to complete informed consent

- Physical or psychological inability to complete sample collection for any reason
including but not limited to: inability to tolerate any study procedures, any physical
limitation that would undermine the safety of the subject in the study, or any
psychiatric or neurological condition that inhibits full comprehension of study
requirements and inability to complete informed consent, as determined by treating
physician

- Currently pregnant or lactating women