Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy

NCT02449837 | Completed DMC

• 1 other identifier: LCCC1408
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Circulating Tumor Cells

Outcome Measures

Primary Outcomes (1)

• To measure CTCs levels to evaluate the change pre- and post-treatment separately in 10 cohorts of patients receiving radiation therapy.

  24 months post-radiation

Secondary Outcomes (1)

• Change in CTC levels from Baseline to Post-RT treatment and the correlation with local tumor response or pathological evaluation, depending on cohort

  24 months post-radiation

Study Arms (10)

Head and Neck Cancer

Patient with 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).

Other: Blood draw

Cervical Cancer

Patients with locally advanced cervical cancer without distant metastasis scheduled for radiotherapy to the pelvic region with or without chemotherapy/targeted therapy (palliative or curative intent).

Other: Blood draw

Non-Small Cell Lung Cancer

Patients with 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).

Other: Blood draw

Rectal Cancer

Patients with locally advanced rectal cancer (no distant metastasis) scheduled to receive neoadjuvant chemoradiotherapy (curative intent).

Other: Blood draw

Metastatic Prostate Cancer

Patients with 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.

Other: Blood draw

Oligometastatic Disease

Patients with 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 or stereotactic body radiotherapy. 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.

Other: Blood draw

Immunotherapy

Melanoma or metastatic NSCLC scheduled to receive ipilimumab, nivolumab, and/or pembrolizumab.

Other: Blood draw

Head and Neck Induction chemotherapy

Locally advanced head and neck cancer (HNSCC) scheduled to receive induction chemotherapy followed by radiotherapy.

Other: Blood draw

Metastatic Breast Cancer

Patients scheduled to receive any treatment, including radiation therapy, and/or systemic/hormonal therapy

Other: Blood draw

Endometrial Cancer

Patients with stage III endometrial cancer, being treated with adjuvant radiation

Other: Blood draw

Interventions

Blood draw OTHER

Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly \~1 month interval), up until 24 months after completion of radiation.

Cervical Cancer; Endometrial Cancer; Head and Neck Cancer; Head and Neck Induction chemotherapy; Immunotherapy; Metastatic Breast Cancer; Metastatic Prostate Cancer; Non-Small Cell Lung Cancer; Oligometastatic Disease; Rectal Cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Written informed consent obtained and signed
• Able to have blood collection without excessive difficulty

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dana Casey, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: May 20, 2015
• Study Start: May 1, 2014
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)