A Pilot Study of Ultra-High Dose Rate (ConformalFLASH®), for Reirradiation of Carcinoma of the Head and Neck (C-FLASH-01)
2026년 6월 11일 업데이트: IBA Proton Therapy, Inc.
This pilot study is designed to evaluate the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) in participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection.
ConformalFLASH treatment planning and delivery workflows are comparable to those of conventional Stereotactic Body Radiation Therapy (SBRT), a standard approach for re-irradiation in this population.
연구 개요
상세 설명
C-FLASH-01 is a pilot study evaluating the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) to participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection.
Stereotactic Body Radiation Therapy (SBRT) re-irradiation is a standard approach that enables highly conformal dose delivery over a limited number of fractions.
ConformalFLASH is an investigational approach that applies SBRT principles using proton therapy delivered at ultra-high dose rates (≥ 40 Gray Relative Biological Effectiveness (GyRBE)/second), with the potential to reduce normal tissue toxicity while maintaining tumor control.
Participants will undergo treatment planning and delivery consistent with standard SBRT workflows.
Treatment consists of five fractions (8 GyRBE per fraction) delivered over approximately 1.5 to 2 weeks.
The primary objective is to assess the feasibility of delivering conformal proton SBRT at dose rates ≥ 40 GyRBE/second, along with evaluation of acute toxicity.
Secondary objectives include assessment of treatment delivery accuracy, late toxicity, clinical outcomes, and patient-reported quality of life.
연구 유형
중재적
등록 (추정된)
10
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sophie Le Bail
- 전화번호: +32 470 226 032
- 이메일: sophie.lebail@iba-group.com
연구 연락처 백업
- 이름: Sofie Gillis
- 전화번호: +32 499 985 686
- 이메일: sofie.Gillis@iba-group.com
연구 장소
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- The University of Pennsylvania, Department of Radiation Oncology
-
연락하다:
- Alexander Lin, MD
-
-
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
- Patients ≥ 18 years old
- Patients ineligible for or decline upfront surgical resection
- Histologically confirmed diagnosis of carcinoma of the head and neck
- Prior receipt of at least 45 GyRBE radiotherapy to the head and neck
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or evidence of similar in the electronic medical record
- Life expectancy of more than 12 weeks
- Ability to understand and the willingness to provide written informed consent and to follow the study procedures
Exclusion Criteria:
- Receipt of prior head and neck radiotherapy within the prior 6 months
- Surgical resection of the current disease in the head and neck
- More than 3 areas of disease requiring reirradiation
- Disease focus exceeding 6.5 cm in greatest dimension
- Presence of distant metastatic disease
- Involvement of any of the following structures: skin, carotid artery, or mandible
- Receipt of concurrent chemotherapy during radiotherapy
- Uncontrolled intercurrent illness including medical and psychiatric, and social situations that would limit compliance with study requirements
- Enrolled in any other investigational studies that involve administrations of another cancer therapeutic (such as surgery, chemotherapy, immunotherapy) during RT
- Pregnant and/or breastfeeding
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
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment Arm
ConformalFLASH irradiation
|
Subjects will be treated with SBRT (8 GyRBE x 5 fractions over 1.5-2 weeks), using pencil-beam scanning proton therapy, delivered at an average dose rate of ≥ 40 GyRBE/second, without chemotherapy.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ConformalFLASH treatment delivery feasibility
기간: Through treatment completion (within 1 month after last fraction)
|
Delivery of ≥ 95% of the prescribed dose to ≥ 95% of the clinical target volume (CTV) at an average dose rate of ≥ 40 GyRBE/second
|
Through treatment completion (within 1 month after last fraction)
|
|
Acute toxicities
기간: Up to 3 months after treatment start
|
Incidence of acute toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 6.0
|
Up to 3 months after treatment start
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ConformalFLASH treatment delivery accuracy
기간: Through treatment completion (within 1 month after last fraction)
|
Dose delivered to the clinical target volume (CTV) and organs at risk (OARs) as well as the average dose rate to the CTV
|
Through treatment completion (within 1 month after last fraction)
|
|
Late toxicities
기간: Beyond 3 months after start of treatment and up to 5 years
|
Incidence of late toxicity as assessed by CTCAE version 6.0
|
Beyond 3 months after start of treatment and up to 5 years
|
|
Local Control
기간: 3 months and 1 year
|
Absence of tumor recurrence or progression at the primary radiated disease site following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
|
3 months and 1 year
|
|
Regional control
기간: 3 months and 1 year
|
Absence of tumor recurrence or progression in regional lymph nodes following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
|
3 months and 1 year
|
|
Metastasis-free survival
기간: 3 months and 1 year
|
Time from first treatment to the first occurrence of distant metastatic disease or death from any cause.
|
3 months and 1 year
|
|
Overall survival
기간: 3 months and 1 year
|
Time from first treatment to death from any cause
|
3 months and 1 year
|
|
Patient-reported quality of life
기간: Up to 5 years
|
Effect of the treatment on patient-reported quality of life, using the University of Washington Quality of Life Questionnaire (UW-QOL).The UW-QOL consists of domains based upon discrete ordinal responses regarding their past 7 days. Scoring is scaled so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. The UW-QOL comprises 12 single-question domains, each between 3 and 6 response options. These options are scaled evenly from 0 (worst) to 100 (best), according to the hierarchy of response. Each domain is scored individually, and an overall composite score can be derived. In addition, patients are asked to choose up to 3 of these domains that they consider most important to them. The UW-QOL also includes 3 global questions, one about how patient feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL. |
Up to 5 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Alexander Lin, MD, University of Pennsylvania
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Vargo JA, Ferris RL, Ohr J, Clump DA, Davis KS, Duvvuri U, Kim S, Johnson JT, Bauman JE, Gibson MK, Branstetter BF, Heron DE. A prospective phase 2 trial of reirradiation with stereotactic body radiation therapy plus cetuximab in patients with previously irradiated recurrent squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):480-8. doi: 10.1016/j.ijrobp.2014.11.023. Epub 2015 Jan 30.
- Heron DE, Ferris RL, Karamouzis M, Andrade RS, Deeb EL, Burton S, Gooding WE, Branstetter BF, Mountz JM, Johnson JT, Argiris A, Grandis JR, Lai SY. Stereotactic body radiotherapy for recurrent squamous cell carcinoma of the head and neck: results of a phase I dose-escalation trial. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1493-500. doi: 10.1016/j.ijrobp.2008.12.075. Epub 2009 May 21.
- Lartigau EF, Tresch E, Thariat J, Graff P, Coche-Dequeant B, Benezery K, Schiappacasse L, Degardin M, Bondiau PY, Peiffert D, Lefebvre JL, Lacornerie T, Kramar A. Multi institutional phase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer. Radiother Oncol. 2013 Nov;109(2):281-5. doi: 10.1016/j.radonc.2013.08.012. Epub 2013 Nov 18.
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 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2027년 12월 1일
연구 완료 (추정된)
2032년 12월 1일
연구 등록 날짜
최초 제출
2026년 6월 2일
QC 기준을 충족하는 최초 제출
2026년 6월 11일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 11일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
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. .
ConformalFLASH irradiation에 대한 임상 시험
-
Centre Hospitalier Emile RouxUniversity of Bordeaux; ANRS, Emerging Infectious Diseases완전한
-
University of LiegeKU Leuven; Maastricht University Medical Center완전한
-
Center for International Blood and Marrow Transplant...National Marrow Donor Program완전한만성 림프구성 백혈병(CLL) | 골수이형성 증후군(MDS) | 급성 골수성 백혈병(AML) | 화학 요법에 민감한 림프종 | 급성 림프구성 백혈병(ALL)/T 림프구성 림프종 | 급성 양성 표현형 백혈병(ABL) | 급성 미분화 백혈병(AUL)미국