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Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

2017년 1월 17일 업데이트: Wake Forest University Health Sciences

A Phase I/II Study of Hypofractionated Stereotactic Body Radiotherapy for Stage I/II Non-small Cell Lung Cancer Within the Central Lung Region and the Prognostic Impact of FDG Positron Emission Tomography

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I or stage II non-small cell lung cancer.

연구 개요

상세 설명

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of hypofractionated stereotactic body radiotherapy (SBRT) to the central lung region (peri-mediastinum) in patients with stage I or II non-small cell lung cancer. (Phase I)
  • Determine local control and time to local progression in patients treated with this regimen. (Phase II)
  • Evaluate the ability of peak standardized uptake values (SUV) for fludeoxyglucose F 18 (FDG)-PET scan, obtained shortly after SBRT (post-treatment), to predict local control and time to progression in these patients.

Secondary

  • Evaluate the ability of maximum SUV for FDG-PET scan, obtained shortly after SBRT, to predict long-term local control and time to progression in these patients.
  • Evaluate the ability of peak SUV and max SUV for FDG-PET scan, obtained prior to SBRT, to predict local control and time to progression in these patients.
  • Determine the utility of PET/CT scan data in guiding treatment planning.
  • Determine if treatment with radiotherapy involving high biological doses with limited treatment volume using these SBRT techniques achieves acceptable treatment-related toxicity.

OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study.

  • Phase I: Patients undergo hypofractionated stereotactic body radiotherapy (SBRT) 3 times within a 2-week time frame.

Cohorts of 3-6 patients receive escalating doses of hypofractionated SBRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients undergo hypofractionated SBRT at the MTD as in phase I. In both phases, patients undergo fludeoxyglucose F 18-PET/CT scans at baseline and at 12-16 weeks after completion of SBRT.

After completion of study treatment, patients are followed periodically for 4 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

연구 유형

중재적

단계

  • 2 단계
  • 1단계

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage I or II non-small cell lung cancer meeting the following criteria:

    • No bronchoalveolar cell carcinoma
    • Maximum T2 or T3 tumor size ≤ 5 cm

      • T3 primary tumor must be limited to chest wall
    • Primary tumor of any T stage must be within or touching the zone of the trachea or proximal bronchial tree, defined as a volume of 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchi, right middle lobe bronchus, right and left lower lobe bronchi)

      • For lesions inferior to the proximal bronchial tree, the primary tumor must be within 2 cm of the esophagus
    • Patients with N1 (hilar) lymph nodes positive for malignancy based on size, fludeoxyglucose F 18 (FDG)-PET scan uptake, or biopsy are eligible if the N1 lymph nodes are located such that they are contiguously within the same stereotactic radiation treatment field as the primary tumor
    • Mediastinal lymph nodes must be ≤ 1 cm and no abnormal uptake on FDG-PET scan in those areas

      • Patients with > 1 cm lymph nodes or abnormal FDG-PET scan (including suspicious but non-diagnostic uptake) are eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer
  • No evidence of distant metastases

    • Suspected M1 disease based on pre-treatment PET imaging must be biopsied

      • If the biopsy is positive, the patient is ineligible
      • If the biopsy is negative and representative of the lesion in question, the patient is eligible
      • If the biopsy is non-diagnostic, consideration should be given to repeat biopsy

        • If the repeat biopsy remains non-diagnostic or a biopsy is not feasible, then the patient is ineligible
  • Technically resectable disease

    • Surgery refused or patient deemed medically inoperable due to co-morbid conditions

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No synchronous primary or invasive malignancy within the past 2 years other than non-melanomatous skin cancer
  • No active systemic, pulmonary, or pericardial infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chest radiotherapy (lung or mediastinum)
  • No other concurrent anticancer therapy, including other radiotherapy, radiofrequency ablation (or other antineoplastic interventional radiology techniques), chemotherapy, biological therapy, vaccine therapy, or surgery

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 마스킹: 없음(오픈 라벨)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
최대 허용 용량(1상)
Time to progression and local control at 1 and 2 years (Phase II)

2차 결과 측정

결과 측정
독성
Rate of acute and late treatment-related toxicity related to specific symptoms, including gastrointestinal, cardiac, neurologic, hemorrhagic, and pulmonary symptoms
Patterns of failure and overall survival at 2 years
Measurement of pre-treatment and post-treatment PET scan standardized uptake values and correlation of this data with local control at 1 and 2 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 1월 1일

연구 등록 날짜

최초 제출

2007년 5월 8일

QC 기준을 충족하는 최초 제출

2007년 5월 8일

처음 게시됨 (추정)

2007년 5월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2017년 1월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 1월 17일

마지막으로 확인됨

2013년 6월 1일

추가 정보

이 연구와 관련된 용어

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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