Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
DAHANCA Proton Feasibility Study
연구 개요
상세 설명
In preparation for a randomised study in Denmark (DAHANCA 35) the feasibility of selecting newly diagnosed patients with squamous cell carcinoma of the pharynx or larynx for proton therapy at the local treatment centers is investigated. A proton and a photon doseplan is prepared for patients planned for primary radiotherapy . If proton radiotherapy reduces the anticipated absolute risk of dysphagia >= grade 2 (DAHANCA scale and/or xerostomia >= grade 2 (EORTC Head-Neck 35) with a clinical relevant value the patient is offered proton therapy at the Danish Center for Particle Therapy. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP).
At least five patients from each of the six Danish centers are required in this feasibility study.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Aalborg, 덴마크
- Aalborg University Hospital
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Aarhus, 덴마크
- Aarhus University Hospital
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Aarhus, 덴마크
- Danish Center for Particle Therapy
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Copenhagen, 덴마크
- Rigshospitalet
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Herlev, 덴마크
- Herlev Hospital
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Næstved, 덴마크
- Næstved Hospital
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Odense, 덴마크
- Odense University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent
A predicted clinical significant reduction in the risk of any of the two primary endpoints (>= grade 2 observer-rated dysphagia or grade 2 patient-reported xerostomia) after proton therapy compared to photon therapy based on comparison of the individual patient dose plans
No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer
Informed consent as required by law
Above 18 years of age
Exclusion Criteria:
Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area, nasopharynx, unknown primary tumor and prior malignancies.
Patients with contraindications for proton therapy (as per 2019 pacemakers, implanted defibrillators and tracheostomy)
Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
Distant metastasis
Previous radiotherapy of the head and neck
Previous surgery for the primary cancer with curative intent
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 |
|---|---|
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실험적: Proton radiotherapy
Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA).
Treatment: 66-68 Gy/ 33-34 fx/ 6/W,with cisplatin 40 mg/m2/W and nimorazole to suitable patients
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Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA).
Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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삼킴곤란 >= 2등급
기간: 방사선 치료 종료 후 6개월
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관찰자가 보고한 삼킴곤란의 비율 >= DAHANCA 후기 독성 점수로 측정한 등급 2(등급 0-4, 0이 최고임)
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방사선 치료 종료 후 6개월
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Xerostomia = grade 2
기간: Six months after end of radiotherapy
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The rate of patient-reported xerostomia measured by the EORTC Quality of life questionnaire (QLQ) Head-Neck (HN) 35 (grade 1-4, with 1 being best)
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Six months after end of radiotherapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Loco-regional tumor control
기간: Up to five years after end of radiotherapy
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Time to event of local-regional failure, from date of randomization to the date of first documented loco-regional failure. Rates are estimated by the Kaplan-Meier method. Interim analyses after 100, 200 and 300 patients. Will not be reported before the primary endpoint. |
Up to five years after end of radiotherapy
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Overall survival
기간: Up to five years after end of radiotherapy]
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From date of randomisation to date of death
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Up to five years after end of radiotherapy]
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Acute toxicity
기간: From the beginning of and up to two months after end of radiotherapy]
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DAHANCA acute toxicity score (grade 0-4, 0 being best)
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From the beginning of and up to two months after end of radiotherapy]
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Late toxicity
기간: From two months to five years after end of radiotherapy]
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DAHANCA late toxicity score (grade 0-4, 0 being best)
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From two months to five years after end of radiotherapy]
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EORTC QLQ-Head-Neck 35
기간: Up to five years after end of radiotherapy
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Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best)
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Up to five years after end of radiotherapy
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EORTC C30
기간: Up to five years after end of radiotherapy]
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Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)
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Up to five years after end of radiotherapy]
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Time from referral to treatment
기간: From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
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Time from referral to proton center to first proton treatment
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From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jeppe Friborg, MD, PhD, Danish Head-Neck Cancer Group (DAHANCA)
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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Proton radiotherapy에 대한 임상 시험
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Joris B.W. ElbersErasmus Medical Center; HollandPTC모병두경부 편평 세포 암종 | 방사선 요법 | 양성자 치료 | 저분할 | 면역 체계 억제네덜란드
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Institut Investigacio Sanitaria Pere VirgiliInstitut Català d'Oncologia; Hospital Universitario Ramon y Cajal; Hospital Arnau de Vilanova 그리고 다른 협력자들모병
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Royal Marsden NHS Foundation TrustMerck Sharp & Dohme LLC종료됨