The most important questions of this phase III trial is:Can adaptive high dose radiotherapy improve loco-regional control without increase of toxicity?
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoints
a. Loco-regional recurrence-free interval at two years
b. Toxicity at two years
c. Evaluation of predictive biomarkers
Secondary outcome
Secondary Endpoints
a. Quality of life during and after treatment
b. Swallowing function preservation at one year
c. Progression Free Survival
d. Overall Survival
Background summary
The standard treatment for advanced head and neck carcinoma is radiotherapy
(RT) with concomitant Cisplatin. Recurrences are predominantly located in the
PET postiive regions. It is anticipated that adaptive inhomogeneous dose
distribution (redistribution) with higher radiation doses on PET GTV areas and
lower doses on the edge will contribute to improved locoregional
progression-free survival with equal toxicity.
Study objective
The most important questions of this phase III trial is:
Can adaptive high dose radiotherapy improve loco-regional control without
increase of toxicity?
Study design
The trial consist of two treatment arms, each 134 patients.
Patients will be randomized between:
1 Cisplatin (100 mg/m2 on day 1, 22 and 43) (standard treatment arm)
Radiotherapy (IMRT):
54,25 Gy (elective)
70 Gy (boost)
35 fractions, seven weeks, concomitant boost technique 5 fractions a week.
2 Cisplatin (100 mg/m2 on day 1, 22 and 43)
Adaptive radiotherapy (IMRT):
54.25 Gy (elective)
67 Gy (range 64-70) (boost PTV-primary minus PTV-PET-GTV)
70 Gy (boost PTV nodes)
77 Gy (mean dose, range 70-84) (boost PTV-PET-GTV)
35 fractions, seven weeks, concomitant boost technique, 5 fractions a
week with adaptation (i.e. new treatment plan) of the treatment plan
according to imaging in week 2.
Intervention
Radiotherapy (arm 1: standard, arm 2: adaptive high dose radiotherapy)
Study burden and risks
All patients are asked to fill out Quality of Life questionnaires.
In the second week of treatment all patients will undergo an extra CT-scan,
MRI and PET- scan.
In the third week of treatment an optional PET-CT scan will be done.
10-12 weeks after the end of treatment all patients will undergo an extra
PET-CT scan.
Optional, patients can give informed consent for the hypoxia study consisting
of two [F]HX-4-PET scans, one pretreatment and one around 20 Gy.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
- Squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx;- Stage III-IV, T3-4, Nx M0;- Age 18 to 70 yrs;- eligible for chemoradiation treatment with adequat renal and hepatic function;- informed consent
Exclusion criteria
- Inability to undergo any one of the treatment arms;- Laryngeal cancer;- Known active symptomatic infections;- Prior surgery, radiotherapy or chemotherapy for this tumour
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2012-000437-39-NL |
| ClinicalTrials.gov | NCT01504815 |
| CCMO | NL37558.031.12 |