to investigate the oncologic outcomes, toxicity and QoL of two commonly used palliative radiation schemes in the Netherlands
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* loco-regional progression
Secondary outcome
* overall survival rates
* the impact of both radiation schemes on QoL
* loco-regional control
* overall response
* compliance to both radiation schemes.
* the incidence of grade * 2 acute and late toxicity
Background summary
A substantial proportion of patients with advanced stage squamous cell
carcinoma of the head and neck (HNSCC) are unsuitable for aggressive radical
treatment with surgery or (chemo)radiotherapy (CRT) because of a very advanced
loco-regional disease, significant comorbidities, poor performance status,
distant metastatic disease, or a combination of these factors. Patients with
untreated advanced stage HNSCC have a median survival of approximately 100
days. This group of patients still requires some form of treatment to control
their loco-regional disease and to alleviate their troublesome symptoms.
Considerations for an optimal palliative RT schedule are: significant tumor
regression and symptom control within as short as possible overall treatment
time (OTT) with minimal side effects. Furthermore, the data about the optimal
radiation dose and fractionation schemes and the impact of these treatment
schedules on quality of life (QoL) of these patients with relatively short life
expectancy is extremely scarce
Study objective
to investigate the oncologic outcomes, toxicity and QoL of two commonly used
palliative radiation schemes in the Netherlands
Study design
prospective, multicenter, phase III, randomized, controlled trial
Intervention
the study will compare a short course of radiotherapy (the so-called melanoma
scheme) (6 fractions of 6 Gy, total dose 36 Gy, twice a week) with a relatively
long course of radiation (the so-called Christie scheme) (16 fractions of 3.125
Gy, total dose 50 Gy, 4 times a week).
In arm 1 t's allowed to have 6 fractions in 4 weeks, 2 in week 1 and 2 and 1
fraction in week 3 and 4 (massive tumor and bad condition).
In arm 2, when patients have limited tumor load and good condition, 5 fractions
a week is permitted.
Study burden and risks
Because most of patients with incurable HNSCC have a poor performance status
and/or major comorbidity and prefer limited number of visits to the hospital,
it is quite reasonable to investigate whether a short scheme of radiotherapy
with limited number of visits to the clinic performs as good as a relatively
long-course of radiotherapy in terms of outcome, toxicity and QoL. This
delicate balance between outcomes, possible toxicity and patient*s comfort
would justify the initiation of such randomized trial. Patients participated in
the study will not undergo additional diagnostic procedures. They need to fill
out the QoL forms at baseline and at 3, 6, 12, 18, and 24 months after
treatment.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
* Newly diagnosed patients with primary non-metastatic carcinoma located in the oral cavity, oropharynx, larynx (except T1 glottic), hypopharynx, nasopharynx, paranasal sinuses and salivary gland and carcinoma of unknown primary in the head and neck region who are not suitable for radical treatment with surgery or (chemo)radiotherapy and, therefore, planned for treatment with radiotherapy in palliative setting.
OR
* Newly diagnosed patients with primary head and neck carcinoma with limited metastatic disease in a good general condition with life expectancy of at least 6 months are also eligible.
* Age * 18 years
* WHO performance status 0 - 2
* Signed written informed consent
Exclusion criteria
* Patients with previously radiation treatment in the head and neck region, for any reason with the exception of basal cell carcinoma of the skin
* Chemotherapy or surgery for head and neck tumor before inclusion and no other
concomitant anti*cancer therapy (in terms of chemotherapy, biological etc) is allowed during study treatment
* Patients with head and neck malignancies arising from skin, nose, thyroid gland or esophagus
* Patients with advanced stage sarcoma or lymphoma of the head and neck region
* Expected life expectancy of less than 3 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02421458 |
| CCMO | NL52512.031.15 |