DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Any new grade >=3 toxicity
研究概览
简要总结
Summary Design Phase II observational
Treatment
- 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx
o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
- Proton radiotherapy
- Concomitant cisplatin for eligible patients*
- Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.
Endpoints
- Primary:
o Any new late toxicity grade >=3 according to CTC AE 5.0
-
Secondary
-
Side effects according to DAHANCA scoring system
-
Quality of life and PROM according to EORTC C30 and HN43
-
Loco-regional control (LRC)
-
Overall survival (OS)
详细描述
Summary Design Phase II observational Inclusion criteria
-
Histological verified loco-regional recurrence or new primary
-
Available dose plan from primary radiotherapy course
-
Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
-
Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
-
Complete Response (CR)* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
-
Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration
-
Absence of distant metastasis at both
-
clinical examination AND
-
PET-CT or CT of thorax and upper abdomen
-
Life expectancy due to age and co-morbidity of >=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
-
PS<=2 (WHO See appendix)
-
The patients should be able to read Danish in order to participate with quality of life questionnaires, but can participate in the rest of the protocol without being fluent in Danish, if capable of reading the patient information.
* Complete Response is defined as the situation when a trained clinician, ideally at a multidisciplinary team conference, defines the patient as in complete remission, based on clinical examination and available imaging. This status can of course later be considered wrong as new information becomes available (sub-centimeter nodes grow etc.) Exclusion criteria
- Radical surgery (R0) and absence of adverse prognostic pathological features
- Lymphoma or malignant melanoma
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
- As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
Treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological verified loco-regional recurrence or new primary
- •Available dose plan from primary radiotherapy course
- •Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
- •Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
- •Complete Response (CR)* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
- •Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration
- •Absence of distant metastasis at both
- •clinical examination AND
- •PET-CT or CT of thorax and upper abdomen
- •Life expectancy due to age and co-morbidity of >=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
- •PS<=2 (WHO See appendix)
排除标准
- •Radical surgery (R0) and absence of adverse prognostic pathological features
- •Lymphoma or malignant melanoma
- •Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
- •As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
结局指标
主要结局
Any new grade >=3 toxicity
时间窗: 3 years after radiotherapy
CTC AE 5.0
次要结局
- Quality of life and PROM(6 months)
- Overall survival (OS)(Median Survival up to 5 years)
- Side effects, any grade(5 years after radiotherapy)
- Loco-regional control (LRC)(5 years after radiotherapy -actuarial analysis)