This Phase II trial aims to:1 Test the predictive value of Zr89 Cetuximab uptake in vivo for treatment specific outcome 2 Explore the impact of dose redistribution on loco-regional control and disease free survival.If individualized treatment…
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
1. Primary Endpoints
a. Locoregional recurrence free survival at two years
b. Correlation of anatomical distribution of Zr89 Cetuximab uptake with
treatment arm and anatomical location of recurrence
Secondary outcome
2. Secondary Endpoints
a. Quality of life during and after treatment, at 6 months and one year
b. Swallowing function preservation at one year
c. Progression Free Survival
d. Overall Survival
e. Toxicity
Background summary
The standard treatment for advanced head and neck carcinoma is Radiotherapy
with concomitant cisplatin. Combination of Radiation with Cetuximab also yields
better results than RT alone. It is unlikely however that the benefit concerns
exactly the same patients. Ultimate goal of the trial is to predict efficacy of
both treatments on beforehand in order to select the optimal treatment for a
patient and avoid unnecessary toxicity. It is also anticipated that adaptive
inhomogeneous dose distribution (redistribution) with higher radiation doses on
PET GTV areas will also contribute to improved locoregional progression free
survival with equal toxicity.
Study objective
This Phase II trial aims to:
1 Test the predictive value of Zr89 Cetuximab uptake in vivo for treatment
specific outcome
2 Explore the impact of dose redistribution on loco-regional control and
disease free survival.
If individualized treatment appears to be feasible, a phase III trial will be
executed to challenge the concept.
Study design
The trial consist of four treatment arms, each 90 patients (i.e. 4x90 patients).
For all patients: 1x Zr89-Cetuximab 400 mg/m2 (pre RT)
Patients will be randomized between:
1 Cisplatin (weekly 40 mg/m2)
Radiotherapy (IMRT) 51.8 (elective)-70 (boost) Gy 35 fractions.
2 Cisplatin: (weekly 40 mg/m2)
Radiotherapy (adaptive IMRT) 51.8 (elective)-67 (64-70) (boost) - 84 (boost on
PET- GTV) Gy 35 fractions
3 Cetuximab
6x Cetuximab (weekly 250mg/m2)
Radiotherapy (IMRT) 51.8 (elective)-70 (boost) Gy 35 fractions.
4 Cetuximab
6x Cetuximab (weekly 250mg/m2)
Radiotherapy (adaptive IMRT) 51.8 (elective) - 67 (64-70) (boost) - 84 (boost
PET-GTV) Gy 35 fractions
Study burden and risks
The patients with cisplatin and radiotherapy treatment undergo an additional Zr
labelled Cetuximab scan this takes around 4 Hrs.
All patients are asked to fill out Quality of Life questionnaires.
Plesmanlaan121
1066 CX Amsterdam
NL
Plesmanlaan121
1066 CX Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Stage III-IV T3-4 SCC Head and Neck, Oropharynx, Oral Cavity or Hypopharynx, Eligible for chemoradiation
Exclusion criteria
Inability to receive one of the treatment arms, laryngeal cancer, previous malignancies
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 |
|---|---|
| CCMO | NL36782.031.11 |