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임상시험 NCT06563362 (DeEscO)은(는) 구인두암에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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취리히 대학교Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma (DeEscO) 2상 120 맞춤형 치료
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06563362 (DeEscO)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 구인두암에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 2월 4일에 시작되어 120명의 참여자를 모집하고 있습니다. 취리히 대학교이(가) 진행하며, 2030년 2월 28일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 18일에 갱신되었습니다.
간단한 개요
Multicentric prospective model-based de-escalation of the elective clinical target volumes (CTV) in radiotherapy of oropharyngeal carcinoma of all stages with the goal to reduce toxicity.
The study investigates the feasibility of this approach as measured by the number of expected out-of-field recurrencies based on the individual patient's state of disease progression and risk factors
상세한 설명
Local treatment of squamous cell carcinoma (SCC) of the oropharynx can consist of surgery, radiotherapy, or a combination of both. When treated with radiation, the target volume contains not only the primary tumor and clinically detected lymph node metastases. In addition, a large part of the lymph drainage system of the neck which is at risk of harboring occult metastases is irradiated, the so called "elective clini...더 보기
공식 제목
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck
질환명
구인두암기타 연구 식별자
- DeEscO
NCT 번호
실제 연구 시작일
2025-02-04
최신 업데이트 게시
2025-11-18
예상 연구 완료일
2030-02-28
계획된 등록 인원
120
연구종류
중재연구
단계/상
2상
상태
모집중
키워드
head and neck cancer
radiotherapy
elective CTV
clinical target volume
de-escalation
radiotherapy
elective CTV
clinical target volume
de-escalation
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Elective target volume de-escalation arm Target volume de-escalation | De-escalation of irradiated volume De-escalation of elective clinical target volumes as recommended by a model-based approach |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
out-of field nodal recurrence rate at 2 years | efficacy of personalized CTV-N reduction in oropharyngeal SCC patients 2 years after the end of the primary (chemo)radiotherapy treatment measured by the Kaplan-Meier estimator for the cumulative probability of out-of-field N-site recurrences (incidence of lymph node metastases in non-irradiated LNLs). | from completion of treatment up to 2 years after radiotherapy |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
out-of field nodal recurrence rate at 3 years | efficacy of personalized CTV-N reduction in oropharyngeal SCC patients measured by the Kaplan-Meier estimator for the cumulative probability of out-of-field N-site recurrences (incidence of lymph node metastases in non-irradiated LNLs) | from completion of treatment up to 3 years after radiotherapy |
Loco-regional control (LCR) rate at 2 years | assessed by the Kaplan-Meier estimator for the cumulative probability of local recurrence of the primary tumor or recurrence in any cervical LNL (both irradiated and non-irradiated LNLs) | from completion of treatment up to 2 years after radiotherapy |
Loco-regional control (LCR) rate at 3 years | assessed by the Kaplan-Meier estimator for the cumulative probability of local recurrence of the primary tumor or recurrence in any cervical LNL (both irradiated and non-irradiated LNLs) | from completion of treatment up to 3 years after radiotherapy |
Progression-free survival (PFS) at 2 years | assessed by the Kaplan-Meier estimator for the cumulative probability of any local, regional, distant progression or death | from completion of treatment up to 2 years after radiotherapy |
Progression-free survival (PFS) at 3 years | assessed by the Kaplan-Meier estimator for the cumulative probability of any local, regional, distant progression or death | from completion of treatment up to 3 years after radiotherapy |
Overall Survival (OS) at 2 years | assessed by the Kaplan-Meier estimator for the cumulative probability of death from any cause | from completion of treatment up to 2 years after radiotherapy |
Overall Survival (OS) at 3 years | assessed by the Kaplan-Meier estimator for the cumulative probability of death from any cause | from completion of treatment up to 3 years after radiotherapy |
Early toxicity of treatment | assessed by grading of toxicities according to CTCAE v5.0 - overall toxicity will be evaluated according to the TAME methodology. | treatment start up to 3 months after treatment |
Late toxicity of treatment | assessed by grading of toxicities according to CTCAE v5.0 - overall toxicity will be evaluated according to the TAME methodology. | >3 months up to 3 years after treatment |
Overall Quality of life at end of treatment | assessed according to paper-based questionnaires EORTC QLQ C30 All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems | at the last day of radiotherapy (+/- 1week) |
Quality of life regarding head and neck specific symptoms at end of treatment | assessed according to paper-based questionnaires, i.e. head and neck module HN43: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems | at the last day of radiotherapy (+/- 1week) |
Overall Quality of life at 6 months after treatment | assessed according to paper-based questionnaires EORTC QLQ C30: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems | at 6 months after the last day of radiotherapy (+/- 2 weeks) |
Quality of life regarding head and neck specific symptoms at 6 months after treatment | assessed according to paper-based questionnaires, i.e. head and neck module HN43: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems | at 6 months after the last day of radiotherapy (+/- 2 weeks) |
Overall Quality of life at 12 months after treatment | assessed according to paper-based questionnaires EORTC QLQ C30: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems | at 12 months after the last day of radiotherapy (+/- 2 weeks) |
Quality of life regarding head and neck specific symptoms at 12 months after treatment | assessed according to paper-based questionnaires, i.e. head and neck module HN43: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems | at 12 months after the last day of radiotherapy (+/- 2 weeks) |
Overall Quality of life at 24 months after treatment | assessed according to paper-based questionnaires EORTC QLQ C30: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems | at 24 months after the last day of radiotherapy (+/- 2 weeks) |
Quality of life regarding head and neck specific symptoms at 24 months after treatment | assessed according to paper-based questionnaires, i.e. head and neck module HN43: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems | at 24 months after the last day of radiotherapy (+/- 2 weeks) |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.
- Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes.
- Age ≥ 18 years, no upper age limit.
- ECOG performance score < 3.
- History/physical examination within 30 days prior to study inclusion by head and neck surgeon and/or radiation oncologist.
- FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory.
- Participants need to provide informed consent.
Inclusion Criteria:
- Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.
- Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes.
- Age ≥ 18 years, no upper age limit.
- ECOG performance score < 3.
- History/physical examination within 30 days prior to study inclusion by head and neck surgeon and/or radiation oncologist.
- FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory.
- Participants need to provide informed consent.
Exclusion Criteria:
- Multilevel primary tumors extending unambiguously beyond the oropharynx into the oral cavity, naso- or hypopharynx
- Distant metastases detected.
- Previous surgery, chemotherapy or radiotherapy treatment for other head and neck cancers.
- Previous surgery in head and neck region affecting the cervical lymphatic system. Dissection of singular lymph nodes for diagnostic purposes before treatment start is allowed.
- Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or intermediate- risk prostate cancer or breast with a progression-free follow-up time of at least 3 years without any remaining disease burden, or other previous malignancy with a progression-free interval of at least 5 years without any remaining active/progressive disease burden regardless whether the treatment is completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy for prostate cancer).
- Pregnancy or breast feeding
- Any severe mental or psychic disorder affecting decision making and ability to provide informed consent.
취리히 대학교257개의 진행 중인 임상시험 탐색 가능연구 대표 연락처
연락처: Panagiotis Balermpas, MD, +41 44 255 35 67, [email protected]
연락처: Debra Lauer, MSc, +41 43 253 28 17, [email protected]
5 1개국에 임상시험 장소
Canton of Zurich
Zurich University Hospital, Zurich, Canton of Zurich, 8091, Switzerland
Panagiotis Balermpas, 연락처
모집중
Cantonal Hospital Aarau, Aarau, Switzerland
Oliver Riesterer, Prof. Dr. med., 연락처, +41 62 838 42 49, [email protected]
모집중
Ospedale Regionale di Bellinzona, Bellinzona, Switzerland
Francesco Martucci, 연락처
모집중
Hôpitaux universitaires de Genève, Geneva, Switzerland
Sébastien Tran, Dr. med., 연락처, +41 22 372 70 90, [email protected]
모집중