NCT03070366Active, not recruitingPhase 2
Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 16 Jan 2017
- Start date
- 21 Sept 2015
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Diseases
- Head and neck cancer
- NCT number
- NCT03070366
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 78
- From 21 Sept 2015 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- contraindication to any systemic therapy (chemotherapy and / or targeted therapy)
- Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix
Other illness
- metachronous primitive tumor (second cancer) uncontrolled.
- 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)
Lab values
- 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.
Other
- Individual deprived of liberty by judicial or administrative decision, or under any kind of guardianship
Who the study is looking for
- 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
Age in the registry: 18 years to 77 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Nord Franche-Comté Coordinator of this site? Confirm its status | Montbéliard | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.