Dose De-escalation and Sentinel LN Mapping Driven Radiotherapy of Contralateral Neck in Ipsilateral Node Positive HNSCC
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- Radiation: Dose de-escalation and / or Volume de-escalation
- Registration Number
- NCT04688528
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
The study involves head and neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, larynx or hypopharynx with positive nodes on only one side of the neck and no distant metastasis treated by primary (chemo)radiotherapy.
The elective node irradiation on the contralateral side is not always mandatory and the dose may be too high. In this study, we evaluate two strategies: the impact of sentinel lymph node mapping to tailor the volumes to irradiate and the dose reduction.
- Detailed Description
The risk of lymph drainage to the contralateral side of the neck is limited to maximum 50% of the patients. Moreover, the risk of occult metastases lies between 20 and 40%. As a consequence, the rule of irradiating the contralateral neck with a prophylactic intent ("elective nodal irradiation") in nearly all HNSCC patients roughly doubles the irradiated volume and, hence, increases the risk of developing more frequent and more severe acute and late side effects. The use of sentinel lymph node mapping to assess the contralateral side of the neck should help to determine the individual drainage to the contralateral side of the neck and, in case of drainage, determine which nodes need to be irradiated. The ultimate goal is to reduce the volume irradiated at prophylactic dose to decrease the risk of severe late side effects (volume de-escalation strategy). This strategy is proposed based on the recent completion of a similar study led by the coordinating investigator, together with the head and neck team of the CHU-UCL-Namur, in HNSCC patients without macroscopic nodes in the neck and treated with (chemo)radiotherapy. It was shown that sentinel lymph node mapping helped to safely individualize and de-escalate the elective nodal irradiation volume and significantly reduce the risk of severe late side effects. Anyway, it is unknown if the whole sub-region of the neck containing the sentinel lymph node(s) or the node(s) only should be defined as target volume.
Moreover, the dose used nowadays for elective nodal irradiation, i.e. 50 Gy in fractions of 2 Gy or biologically equivalent, dates back from the 70's. Many arguments (a.o. our better capacity to stage the neck with 3D imaging and the use of concomitant chemotherapy in the majority of node-positive HNSCC) are in favour of dose de-escalation. A multicentric randomized study performed in 100 HNSCC recently showed that the elective dose could be reduced to 40 Gy in fractions of 2 Gy or biologically equivalent, helping to reduce the risk of late dysphagia at 6 months post-radiotherapy. Confirmatory studies need to be performed on larger groups of patients.
The primary aim is to evaluate contralateral regional control (cRC) rate at 2 years in head and neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, larynx or hypopharynx with positive nodes on only one side of the neck and no distant metastasis treated by (chemo)radiotherapy applying a dose- and/or volume de-escalation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 147
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Unilateral RT Dose de-escalation and / or Volume de-escalation If SPECT/CT shows ipsilateral drainage and the tumor does not cross the midline, the subject will automatically be assigned to Arm A, and will receive ipsilateral Radiotherapy with reduced prophylactic dose outside of the macroscopically involved nodes. The contralateral side of the neck will be spared according to the absence of sentinel lymph node drainage. Arm C: SLN alone Dose de-escalation and / or Volume de-escalation If SPECT/CT shows contralateral drainage, the subject will be randomized between 'Whole level' and 'SLN alone'. Arm C 'SLN alone': on the contralateral side of the neck, only the sentinel node(s) will be irradiated at the reduced prophylactic dose. The ipsilateral side of the neck will be irradiated conform to arm A. Arm B: Whole level Dose de-escalation and / or Volume de-escalation If SPECT/CT shows contralateral drainage, the subject will be randomized between 'Whole level' and 'SLN alone'. Arm B 'Whole Level': on the contralateral side of the neck, the whole level(s) containing the draining sentinel lymph node(s) will be irradiated at the reduced prophylactic dose. The ipsilateral side of the neck will be irradiated conform to arm A.
- Primary Outcome Measures
Name Time Method Contralateral regional control (cRC) rate at 2 years From baseline to 2 years after radiotherapy The rate of tumor control in the draining nodal regions of the neck.
- Secondary Outcome Measures
Name Time Method Survival Time from RT until death from any cause Overall survival
Radiotherapy induced toxicity Time from start of RT up to 2 years after RT Acute and Late Toxicity Scoring
Local Control Time from RT until local progression or death whichever comes first, up to 2 years after RT. Loco-regional control (LRC)
Questionnaire assessing the quality of life of patients with head and neck cancer From baseline to every 2 months in the first year and every 3 months in the second year after radiotherapy. Measured by the EORTC QLQ-H\&N35 questionnaire.
Questionnaire assessing the quality of life of cancer patients. From baseline to every 2 months in the first year and every 3 months in the second year after radiotherapy. Measured by the EORTC QOL-C30 (version3) questionnaire.
Normal tissue complication probability (NTCP) gain estimation Time from RT up to 2 years after RT. Estimation of the difference in risk of complications for xerostomia, dysphagia and hypothyroidism according to validated NTCP models.
Trial Locations
- Locations (10)
OLV Aalst
🇧🇪Aalst, Belgium
UCL Saint-Luc
🇧🇪Brussel, Belgium
Institute Jules Bordet
🇧🇪Brussel, Belgium
University Hospital Gent
🇧🇪Gent, Belgium
AZ Sint-Maarten
🇧🇪Mechelen, Belgium
CHU-UCL Namur
🇧🇪Namur, Belgium
AZ Turnhout
🇧🇪Turnhout, Belgium
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
ZOL
🇧🇪Genk, Limburg, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Limburg, Belgium