Clinical trial NCT03070366: Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC
Official title: Randomized Phase II Trial Comparing Chemotherapy Combined With Stereotactic Radiotherapy and Stereotactic Radiotherapy Alone, for Treatment of Oligometastases in Squamous Cell Cancers of the Upper Aerodigestive Tract
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Oligometastasis
stereotactic irradiation
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the rate of living patients at 1 year with a quality of life criteria (no decrease) and reduced toxicities. This criteria will be compared in both groups., A cost effectiveness study is scheduled also.

Detailed description: Patients with cancers of aerodigestive tract have metastases limited in their evolution and a pauci-metastatic disease. In these cases, systemic therapy is the standard attitude. However, patients often received chemotherapy in their history and response rates are relatively low. The median survival is between 7 and 11 months with secondary effects and degradation of quality of life. It is a palliative treatment. Data on systemic treatment in the context of a micro-metastatic disease are limited. In contrast, stereotactic irradiation in pauci-metastatic context leads to better local control rates and may sustainedly reduce the progression of metastatic disease.

Stereotactic radiotherapy is increasing use in clinical practice for limited metastatic stages (oligo metastatic with 1-3 synchronized metastases). Radiotherapy in this indication has major advantages and a similar efficacy compared with other ablative treatments.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* PS:0-2
* Estimated life expectancy ≥ 6 months
* Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck
* Target metastases can be treated in stereotactic radiotherapy
* 1-3 synchronized metastases with unrestricted anatomic site
* Greater cumulative diameter of synchronous metastases in once organ (liver, lung or brain) ≤ 6 cm with GTV = Clinical Target Volume (CTV)
* Global maximum diameter (GTV) allowed for pulmonary oligometastases (less than 2 cm from the mediastinum), brain, node, is ≤ 3cm
* Implementation of a method for taking into account movements and uncertainties (IGRT) for limiting the margin of CTV to PTV (PTV) so as not to exceed 7 cm large cumulative diameter of PTV
* Performing a positron emission tomography with 18F-2-fluoro-2-deoxy-D-glucose (FDG-PET) 4 weeks before the inclusion
* In case of cerebral metastases, MRI diagnostic is required
* If locoregional disease is treated, controlled and non-progressive for more than three months (+/- 4 weeks) at baseline, synchronized initial tumor is possible
* If metachronous metastases, locoregional disease previously treated should be monitored and considered not progressive for more than three months at baseline
* In case of prior cancer other than HNSCC, complete remission for over 5 years is possible, any biopsy of metastases is left to the appreciation of referring physician
* No chemotherapy or local treatment of metastases in the previous 6 months
* Laboratory tests consistent with the achievement of chemotherapy: Leukocytes\> 3,000 / mm3 (including polynuclear\> 2000 / mm3) platelets\> 150,000 / mm3, serum glutamate oxaloacetate transminase (SGOT), serum glutamate pyruvate transaminase (SGPT), alkaline phosphatase, bilirubin \<2.5 upper limit of normal (ULN)
* Affiliation to an health insurance
* Informed Consent Form signed

Exclusion Criteria:

* Concomitant participation in other interventional clinical trial within 4 weeks before inclusion
* Other prior ablative treatment of targets metastases (surgery, radio frequency) in the previous six months
* metachronous primitive tumor (second cancer) uncontrolled.
* contraindication to any systemic therapy (chemotherapy and / or targeted therapy)
* Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, platin or cetuximab
* Active infection (infection requiring IV antibiotics), including active tuberculosis and known and declared human immunodeficiency virus (HIV)
* Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix
* Individual deprived of liberty by judicial or administrative decision, or under any kind of guardianship
* Pregnant or breast feeding women. Every woman who has childbearing potential, must have a negative pregnancy test (serum or urine) within 14 days previous treatment. Patients (men or women) must use a reliable method of contraception throughout treatment and for at least 6 months after discontinuation of chemotherapy.

Primary outcomes:
measure: Overall Survival without quality of life deterioration
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival
timeFrame: 1 year
measure: Progression free survival
timeFrame: through study completion, an average of 1 year
measure: Number of participants with adverse events grade 3 as assessed by CTCAE v4.0 within the first 6 months of treatment
timeFrame: up to 6 months
measure: Number of participants with treatment related adverse events as assessed by CTCAE v4.0
timeFrame: through study completion, an average of 1 year
measure: Overall response rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Montbéliard
country: France
facility: Hôpital Nord Franche Comté
Study officials:
References: