Enhancing Native American Participation in RT Trials

描述(由申请人提供)：位于南达科他州拉皮特城的癌症护理研究所(CCI)从三个保留地为大约100,000名美洲原住民提供服务。一些患者距离癌症中心的路程长达四个小时。将调查如何确定阻止美洲原住民出现早期癌症的障碍，或者在某些情况下根本不会出现。一份文化响应性问卷将被随机抽取到保留区内没有癌症的美洲原住民手中。第二份问卷将发给癌症患者，并解决类似的问题，但集中在其他与肿瘤学相关的问题上。据推测，一个主要障碍是离家近的文化/社区根源的地理错位。传统的放射治疗包括6至8周的疗程和每日治疗。这种治疗方法可能是一个主要障碍。采用调强放疗、近距离放射治疗等先进技术，可将疗程缩短至1~4周。因此，为了解决这一障碍，已经开发了缩短治疗时间的临床试验。对于美洲原住民中常见的恶性肿瘤，建议进行一系列第二阶段研究：转移性疾病、非小细胞肺癌(NSCLC)、乳腺癌、前列腺癌和头颈部(H和N)癌。对于I期和II期乳腺癌患者，高剂量率(HDR)近距离放射治疗将取代常规的外照射疗程。晚期前列腺癌患者将接受为期2周的适形外放射治疗，然后在雄激素消融的同时植入HDR。建议对转移性疾病、局部晚期H&N和非小细胞肺癌患者进行试点放射治疗试验。最后的试点试验将调查单独使用HDR近距离放射治疗早期前列腺癌的情况。可能存在一种使美洲原住民对辐射更加敏感的遗传环境。因此，将进行一项实验室研究，以调查美洲原住民是否具有较高的AT(共济失调-毛细血管扩张症)基因突变率，该基因通过外周血淋巴细胞的高效液相色谱测定。通过患者教育、筛查、评估医疗保健的潜在障碍和创新的治疗策略，希望美洲原住民最终将在他们的疾病过程中更早地出现。

DESCRIPTION (provided by applicant): The Cancer Care Institute (CCI) in Rapid City, South Dakota, serves approximately 100,000 Native Americans from three reservations. Some patients live up to four hours from the cancer center. Identifying barriers which prevent Native Americans from presenting with earlier stages of cancer, or in some circumstances not at all, will be investigated. A culturally responsive questionnaire will be administered to randomly selected Native Americans on the reservation who do not have cancer. A second questionnaire will be given to cancer patients, and address similar issues, but concentrate on additional questions of oncologic relevance. It is hypothesized that a major barrier is geographic dislocation from cultural/community roots close to home. Traditional radiotherapy involves a 6 to 8 week course and daily treatments. This treatment approach may represent a major barrier. With the use of advanced technologies such as intensity modulated radiotherapy and brachytherapy, the treatment course can be shortened to 1 to 4 weeks. Therefore, to address this barrier, clinical trials have been developed which shorten treatment duration. A series of phase II studies are proposed for malignancies commonly seen among the Native Americans: metastatic disease, non-small cell lung (NSCLC), breast, prostate and head and neck (H and N) cancer. For patients with stage I and II breast cancer, high-dose-rate (HDR) brachytherapy will be substituted for a conventional course of external beam radiation. Patients with advanced prostate cancer will be treated with a 2 week course of conformal external beam radiation followed by an HDR implant in combination with androgen ablation. Pilot tomotherapy trials are proposed for patients with metastatic disease, locally advanced H&N, and NSCLC. The final pilot trial will investigate the use of HDR brachytherapy alone for early stage prostate cancer. A genetic milieu may exist which renders Native Americans more sensitive to radiation. Therefore, a laboratory study will be conducted to investigate whether Native Americans have a higher mutation rate of the AT (ataxia-telangiectasia) gene determined through HPLC of the peripheral blood lymphocytes. Through patient education, screening, assessing potential barriers to health care, and innovative treatment strategies, it is hoped that Native Americans will eventually present earlier in their disease process.