STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03

Head and Neck Neoplasms Clinical Trial

— STEREOPOSTOP  

Official title:

A Multicenter Prospective Phase II Study of Postoperative Hypofractionated Stereotactic Body Radiotherapy (SBRT) in the Treatment of Early Stage Oropharyngeal and Oral Cavity Cancers With High Risk Margins.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03401840
• Other study ID #: 2017-A02058-45
• Secondary ID: PHRC-K16-164
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this national, open-label, non-randomized phase II trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Operated squamous cell carcinoma of oral cavity (lips excepted) or oropharynx

• pT1 or pT2 ((UICC 7th edition 2009)

• Indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria :

• positive R1 margin (re-resection not proposed)

• close margin < 5 mm (re-resection not proposed)

• Margin estimated at risk, with uncertain pathological margin (re-resection not proposed)

• N0 after surgical management of the neck (neck dissection or sentinel lymph node biopsy) or pN1 without extracapsular extension (carcinological neck dissection)

• Age = 18 years

• ECOG status = 2

• Written signed informed consent before any specific procedure of the protocol

• Affiliation to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

• Other histology than squamous cell carcinoma

• pT3 or pT4

• pT2>3cm and R1 with concurrent chemoradiotherapy decided in multidisciplinary tumor board

• Lymphovascular invasion justifying neck irradiation

• Neck irradiation decided in multidisciplinary tumor board

• Lack of at least one of the following elements :

• pre-operative medical imaging (CT scan or MRI)

• endoscopy report

• surgery report

• pathological report

• Prior radiotherapy to the head and neck area

• Distant metastasis

• Pregnant or nursing (lactating) woman

• women or men of childbearing age not taking adequate contraceptive measure

• participation in another investigational study within 4 weeks prior to inclusion

• History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix

• Persons deprived of their liberty, under guardianship or curatorship, or unable to follow the trial for geographical, social or psychological reasons

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Radiation:
• postoperative hypofractionated stereotactic radiotherapy
total dose of 36Gy in 6 fractions over 11-13 days

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Institut Bergonié	Bordeaux
France	Polyclinique bordeaux Nord Aquitaine	Bordeaux
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Georges François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier de Bretagne Sud /Site du Scorff	Lorient
France	Centre Léon Bérard	Lyon
France	Hôpital Nord Franche-Comté	Montbéliard
France	Institut de Cancérologie de Montpellier, Val d'Aurelle	Montpellier
France	Hôpital Tenon	Paris
France	Hôpital Universitaire Pitié Salpêtrière - Charles Foix	Paris
France	Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux	Pessac
France	Centre Hospitalier Lyon-Sud	Pierre-Bénite
France	Institut Jean Godinot	Reims
France	Centre Henri Becquerel	Rouen
France	Centre Hospitalier Privé Saint Grégoire	Saint Grégoire
France	Institut de Cancérologie Lucien Neuwirth	Saint Priest en Jarez cedex
France	Institut de Cancérologie de l'ouest, Site René Gauducheau	Saint-Herblain
France	Centre Paul Strauss	Strasbourg
France	Clinique Pasteur	Toulouse
France	Institut Claudius Regaud	Toulouse
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Jean Perrin	GORTEC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severe late toxicity	2-year toxicity of grade = 3 related to SBRT according to CTCAE V4.03 classification.	from 3 months to 2 years following the end of radiotherapy
Secondary	Local control	2-year local control rate - Any local recurrence (T) will be considered as an event.	2 years following the end of radiotherapy
Secondary	Locoregional control	2-year locoregional control rate - Any local (T) or lymph node (N) recurrence will be considered as an event	2 years following the end of radiotherapy
Secondary	Acute toxicity	= 3-month toxicity of grade = 3 related to SBRT according to CTCAE V4.03 classification.	from the first fraction to 3 months after the end of radiotherapy
Secondary	disease free survival (DFS)	2-year DFS rate - DFS is time from randomization to the date of first occurrence of any locoregional recurrence, distant progression or death from any cause.	2 years following the end of radiotherapy
Secondary	Overall survival (OS)	2-year OS rate - OS is defined as time from randomization to death from any cause	2 years following the end of radiotherapy
Secondary	Quality of life (global evaluation)	evaluated by EORTC QLQC30	at baseline, 1 month, 1 year and 2 years post radiotherapy
Secondary	Quality of life (specific evaluation for Head and Neck Cancer)	evaluated by EORTC QLQ HN35 module	at baseline, 1 month, 1 year and 2 years post radiotherapy
Secondary	Nutritional impact	evaluated by weight loss	during 2 years following the end of radiotherapy
Secondary	Nutritional support	evaluated by the use of feeding tubes	during 2 years following the end of radiotherapy
Secondary	Predictive factors of toxicity	clinical and/or dosimetric factors associated to late severe toxicities (grade = 3 related to SBRT according to CTCAE V4.03 classification).	2 years following the end of radiotherapy