Clinical trial NCT02449837: Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy
Official title: Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulating Tumor Cells
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing radiation treatments at Lineberger Comprehensive Cancer Center at UNC Hospitals for one of eight cancer types: head and neck, cervical, rectal, lung, prostate, endometrial, metastatic breast, and oligometastatic cancer with any solid tumor histology. Additionally, patients undergoing immunotherapy at Lineberger Comprehensive Cancer Center at UNC Hosptials, or undergoing induction chemotherapy for treatment of head and neck cancers.

Brief summary: The purpose of this study is to investigate the level of Circulating Tumor Cells (CTCs) in cancer patients before and after undergoing treatment regimens where the primary treatment modality is radiation therapy (XRT). Specifically, there is interest in the change in CTCs pre- and post- XRT, both in absolute and relative terms.

Detailed description: 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.

Eligibility criteria: 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 or with high risk prostate cancer; 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; Metastatic breast cancer scheduled to receive any treatment, including radiation therapy and/or systemic/hormonal therapy; Stage III endometrial cancer scheduled to receive radiation therapy
* 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

Primary outcomes:
measure: To measure CTCs levels to evaluate the change pre- and post-treatment separately in 10 cohorts of patients receiving radiation therapy.
timeFrame: 24 months post-radiation
Secondary outcomes:
measure: Change in CTC levels from Baseline to Post-RT treatment and the correlation with local tumor response or pathological evaluation, depending on cohort
timeFrame: 24 months post-radiation
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Dana Casey, MD
role: PRINCIPAL_INVESTIGATOR
References: