Combined hypofractionated stereotactic body radiotherapy with immunomodulating systemic therapy for inoperable recurrent head and neck cancer.
- Conditions
- local, regional or combined locoregional recurrence of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in previously irradiated tissue, with former irradiation with curative intent.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000133-31-BE
- Lead Sponsor
- Z Gent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
?Histologically confirmed local, regional or combined locoregional recurrence of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx or cancer of unknown primary (CUP) in the neck in previously irradiated tissue, with former irradiation with curative intent.
?Patients with non-symptomatic distant metastases and local, regional or combined locoregional recurrence can be included.
?In case of non-metastatic disease, the recurrence must be primarily unresectable recurrence and/or patients refused surgery.
?Time interval 6-24 months after the end of the initial radio(chemo)therapy for primary head and neck cancer.
?Decision of the Head and Neck Tumor Boards at the recruiting centre to offer salvage radio(chemo)therapy, palliative chemotherapy or anti-PD-1 antibody treatment with nivolumab for cisplatin-refractory locoregional recurrent head and neck squamous cell carcinoma.
?Karnofsky performance status = 70.
?Age = 18 years old.
?Informed consent obtained, signed and dated before specific protocol procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
?Previous radiotherapy was for cT1-2 cN0 M0 glottic cancer.
•Grade = 4 late toxicity after the initial radio(chemo)therapy.
?Brachytherapy as treatment for second primary / recurrence.
?Previous (combination with) immunotherapy for the primary or the recurrent squamous cell carcinoma.
?Impossibility of oral intake of cylophosphamide.
?For patients receiving cyclophosphamide: Necessary intake during therapy of allopurinol, amiodarone, digoxin, hydrochlorothiazide, indomethacin, phenobarbital, phenytoin, warfarin. clopidogrel, ticlopidine, carbamazepine, efavirenz, rifampicine, ritonavir
?High risk for arterial blow-out: 1 of following criteria is sufficient to exclude patients:
o(1) soft tissue necrosis
o(2) skin invasion of the recurrent cancer
o(3) circumferential involvement of > 180° of a carotid artery)
?Symptomatic distant metastases.
?Other uncontrolled second primary tumors.
?Pregnant or lactating women.
?Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
?Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To derive the maximum tolerated dose of hypofractionated stereotactic body radiotherapy (SBRT) using dose painting by numbers with immunomodulating systemic therapy in patients that are reirradiated for recurrent squamous cell carcinoma of the head and neck.;Secondary Objective: ?To assess symptom palliation<br>?To assess local control.<br>?To estimate overall and progression-free survival. <br>?To estimate grade = 3 toxicity-free survival<br>?To assess quality-of-life (QOL)<br>?To assess the topographic distribution of recurrence (inside/outside FDG-avid GTV)<br>?To assess time to further treatment <br>?To assess the immune response;Primary end point(s): Safety, defined as absence of grade = 4 acute or subacute toxicity until 3 months after treatment and absence of grade = 3 mucosal ulceration or any other kind of grade = 3 toxicity > 3 months after treatment).;Timepoint(s) of evaluation of this end point: 3 months after treatment and end of follow up
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ?Toxicity scoring (CTCAE version …)<br>?Local control<br>?Overall and disease-free survival<br>?QOL<br>?topographic distribution of recurrence (inside/outside FDG-avid GTV)<br>?time to further treatment<br>?the immune response;Timepoint(s) of evaluation of this end point: - end of trial