- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02059967
Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC
A Phase I Image-Guided Adaptive Radiotherapy Study Using Active Breathing Control (ABC) and Simultaneous Integrated Boost for Patients With Inoperable Non-Small Cell Lung Cancer
연구 개요
상태
개입 / 치료
상세 설명
OUTLINE: This is a dose-escalation study of IGART.
Patients undergo IGART using active breathing control (ABC) 5 days a week for 7 weeks, for a total of 33 fractions with simultaneous integrated volume adapted boost (SIVAB) during fractions 26-33. Patients also receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
After completion of study treatment, patients are followed up periodically for 5 years.
연구 유형
단계
- 1단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically-proven (by biopsy or cytology), unresectable or inoperable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma not otherwise specified.
- The tumor stage must be Stage IIA-IIIB (AJCC 7th edition). See http://aboutcancer.com/AJCC 7th lung 1.gif and http://aboutcancer.com/AJCC 7th lung 2.gif for staging.
- All detectable tumor must be encompassed by radiation therapy fields.
- 18-fluorodeoxyglucose PET is required for staging and treatment planning.
- Atelectasis, if present, must involve less than a complete lung.
Laboratory values:
- Neutrophils >1500/µL
- Platelets >100,000/µL
- Bilirubin < 1.5 mg/dL
- Aspartate aminotransferase (AST; formerly serum glutamic oxaloacetic transaminase [SGOT]) < 2x upper limit normal
- Alanine aminotransferase (ALT; formerly serum glutamic pyruvic transaminase [SGPT]) < 2x upper limit normal
- Serum creatinine < 2.0 mg/dL
- Glomerular filtration rate (GFR) calculated (kidney function test) within 30 days must be ≥ 59 mL/min
- Pulmonary function test (PFT) with FEV-1 ≥ 1.0 L/sec
- Plan of curative radiotherapy with or without concurrent chemotherapy.
- Karnofsky Performance Scale score of ≥ 70%.
- Age ≥ 18 years old.
- Measurable disease on the planning CT.
Patient must have a completed IMRT plan to 66 Gy in 2 Gy fractions with ≥ 95% of the PTV covered by the prescription dose, and the attending physician must have reviewed and approved the DVHs as follows:
- total lung V20 Gy ≤ 30%
- mean esophageal dose ≤ 34 Gy
- esophageal planning organs-at-risk volume (PRV) V60 Gy ≤ 30%
- heart V40 Gy ≤ 50%
- maximum brachial plexus dose ≤ 66 Gy
- maximum spinal cord PRV dose ≤ 50 Gy
- maximum aorta dose ≤ 66 Gy
- maximum main bronchus dose ≤ 66 Gy
- maximum dose ≥ 66 Gy allowed in only one lobar bronchus.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- Prior radiation therapy to the thorax.
- Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past 5 years.
- Clinically significant pleural effusions, pericardial effusions, or superior vena cava syndrome.
- Oxygen supplementation required during therapy.
- Involvement of the brachial plexus, or infiltration of the aorta, heart, or esophagus.
- Tumors that affect more than one lobar bronchus, except the second involved bronchus in the right middle lobe bronchus.
- Unable to perform the BH procedures, unless tumor motion is ≤ 3 mm.
- Myocardial infarction within the last 6 months, symptomatic heart disease, uncompensated chronic obstructive pulmonary disease (COPD), or uncontrolled bronchospasms.
- History of a prior malignancy from which the patient has not been disease free for a minimum of 2 years, other than adequately treated basal/squamous skin cancer or in situ cervix cancer or other in situ malignancy.
- Pregnant or lactating women.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)
Patients undergo IGART using ABC 5 days a week for 7 weeks, for a total of 33 fractions with SIVAB during fractions 26-33.
Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
|
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
IGART 진행
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
MTD, defined as the highest dose level at which =< 3 out of 7 patients experience a dose-limiting toxicity
기간: 3 months
|
(using daily image-guidance, deformable image registration, adaptive replanning at defined time points, and dose intensification at normal tissue tolerance) of radiotherapy delivered concomitantly with standard chemotherapy.
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incidence of acute toxicity measured using the National Cancer Institution Common Terminology for Adverse Events version 4.0
기간: Up to 90 days from radiation therapy start
|
Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.
|
Up to 90 days from radiation therapy start
|
Incidence of late toxicity measured using the Radiation Therapy Oncology Group Late Radiation Morbidity Scoring
기간: Up to 5 years
|
Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.
|
Up to 5 years
|
Practicability of the approach
기간: Up to 5 years
|
Variations in respiratory patterns, tumor and CTV positions, as well as tumor volumes will be assessed on the respective under-treatment imaging studies.
The feasibility of deformable image registration will be benchmarked against manual contours of targets and normal tissue.
The practicability of IGART will be measured by assessing the necessary time, IT and personnel resources needed to conduct the study.
|
Up to 5 years
|
Tumor response evaluated according to Response Evaluation Criteria in Solid Tumors v1.1
기간: Up to 15 years
|
Up to 15 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Elisabeth Weiss, MD, Virginia Commonwealth University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- MCC-13-09209
- HM20000101 (기타 식별자: IRB)
- MCC-20000101 (기타 식별자: VCU Massey Cancer Center)
- NCI-2014-00163 (레지스트리 식별자: NCI)
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