NCT00924027已完成2 期
A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall
研究概览
简要总结
Background:
- One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed.
- Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment.
Objectives:
- To evaluate the quality of the brachytherapy procedure at the National Institutes of Health Radiation Oncology Branch.
Eligibility:
- Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment.
Design:
- In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history.
- Each treatment will take place in the Radiation Oncology Clinic.
- If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan.
- The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes.
- The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient.
- Patients will return to the Radiation Oncology Clinic for follow-up visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Follow-up evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, magnetic resonance imaging (MRI), X-ray) that was done at baseline to evaluate the tumor response.
详细描述
BACKGROUND:
- High dose rate brachytherapy (HDR) is a challenging technique utilized in many malignancies in order to deliver a high dose of radiation therapy to a tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue
- HDR therapy has been targeted to particular subsites as an integral part of either definitive management or palliation for malignancy-related symptoms.
OBJECTIVES:
- The primary objective is to determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch. An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the Gross Tumor Volume (GTV) receives 85% of the prescribed dose. An implant will be inadequate if the above dose limitations are not met.
- To evaluate local control and late toxicity rates following brachytherapy at the NCI ROB
- To increase the flow of oncology participants requiring brachytherapy to the National Cancer Institute (NCI) Radiation Oncology Branch (ROB), as these participants lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, clinical fellows, and physicians.
ELIGIBILITY:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Pathologically confirmed malignancy for which high-dose rate brachytherapy is appropriate as a component of their therapeutic regimen.
- •Age greater than 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Participant must have a primary medical or surgical oncologist in the community or at National Cancer Institute (NCI) who is willing to collaborate with the Radiation Oncology Branch (ROB) staff in the clinical management of the participant.
- •Participants of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
- •Site-specific inclusion criteria (any one or more of the following):
- •Gynecologic Cancers:
- •Endometrial cancer
- •Participants at a higher risk of recurrence (because of either grade, myometrial invasion, lymphatic vascular space invasion, tumor size, lymph node status, tumor extension, presence or absence of surgical staging)
- •Participants who have suffered a recurrence at the vaginal cuff
- •Participants who are unable to undergo surgery and must have treatment for an inoperable primary endometrial cancer.
- •Cervical cancer
- •Participants who are unable to undergo surgery and must have treatment for an inoperable primary cervical cancer.
- •Participants with locally advanced cervical cancer in whom brachytherapy will be integrated as a boost to external beam radiation either in a palliative or curative setting (definitive or post-operative setting).
- •Lung cancer
- •Participants with an endobronchial component causing symptoms
- •Participants who cannot undergo resection because of poor lung function or distant lung metastasis
- •Breast cancer
- •Infiltrating ductal carcinoma or ductal carcinoma in-situ (DCIS), stage T0, T1, and T2 less than or equal to 3.0 cm, N0 and M0,
- •Participants benefiting from high dose radiation (HDR) as either as a boost or accelerated partial breast irradiation regimen.
- •Prostate Cancer
- •Participants with localized prostate cancer (T1b-T3b) in whom brachytherapy will be integrated as a boost to external beam radiation or used as monotherapy for definitive management.
排除标准
- •Cognitively impaired participants who cannot give informed consent.
- •Participants currently receiving concurrent investigational chemotherapeutic agents.
- •Participants receiving concomitant chemotherapy administration in the 5 days preceding brachytherapy (except for gynecological cancer patients who may have received concurrent chemotherapy as a component of their treatment regimen)
- •Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn.
- •Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the judgment of the Principal or Associate Investigator would compromise the participant s ability to tolerate this therapy or are likely to interfere with the study procedures or results.
- •Participants who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment.
- •Abnormal bleeding times or active anti-coagulation therapy.
- •platelets less than 100,000 per mm(3)
- •Prothrombin time (PT)/Partial thromboplastin time (PTT) greater than 1.5 the upper normal limit (UNL)
- •Any participant or tumor/anatomical factors that may prevent brachytherapy apparatus from being properly and safely inserted and positioned and from radiation therapy being administered per American Brachytherapy Society (ABS) guidelines.
- •Participants whose malignancy has one or more of the following site-specific criteria disqualifying them from the study:
- •1. Breast cancer:
- •Participants inappropriate for standard breast conservation therapy (Multicentric disease, inability to achieve clear margins);
- •male participants with breast cancer
- •autoimmune disorders, including systemic lupus erythematosus (SLE), Scleroderma, etc.
- •distant metastases;
- •2. Prostate cancer:
- •distant metastases
- •lymph node metastases
研究组 & 干预措施
1/Radiation Therapy
Experimental
Radiation therapy given as high dose radiation (HDR) Brachytherapy.
干预措施: High Dose Radiation (HDR) Brachytherapy (Radiation)
1/Radiation Therapy
Experimental
Radiation therapy given as high dose radiation (HDR) Brachytherapy.
干预措施: MRI (Diagnostic Test)
1/Radiation Therapy
Experimental
Radiation therapy given as high dose radiation (HDR) Brachytherapy.
干预措施: CT (Diagnostic Test)
1/Radiation Therapy
Experimental
Radiation therapy given as high dose radiation (HDR) Brachytherapy.
干预措施: PET Scan (Diagnostic Test)
结局指标
主要结局
Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall
时间窗: All participants were assessed 1 week after last dose of high dose radiation (HDR) brachytherapy, an average of 1 week (no range).
An implant is adequate if 90% of the Gross Tumor Volume (GTV) receives 90% of the dose prescribed and 80% of the Clinical Tumor Volume (CTV) receives 85% of the prescribed dose. An implant is inadequate if the above criteria is not met. A GTV only applies to certain disease sites such as gynecologic cancer that have not been removed by surgery and CTV applies to prostate or gynecologic cancer that have been removed surgically.
次要结局
- Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall(Assessed at 12 months after radiation)
- Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall(Date treatment consent signed to date off study, approximately 159 months and 21 days.)
- Number of Prostate Participants With Local Control(Assessed at 12 months after radiation)
- Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall(Assessed at 12 months after radiation)
- Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall(Date treatment consent signed to date off study, approximately 159 months and 21 days.)
- Number of Participants Accrued Who Received Brachytherapy Each Year(Approximately 16 years)
研究者
Deborah Citrin, M.D.
Investigator
National Cancer Institute (NCI)
研究点 (1)
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