Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma

Oropharynx Cancer Clinical Trial

— ARTIX  

Official title:

Phase III Trial Testing the Benefit of Intensity-modulated Radiotherapy With Weekly Replanifications Versus Intensity Modulated Radiotherapy With Only One Planification in Locally Advanced Oropharynx Carcinoma for Decreasing Xerostomia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874587
• Other study ID #: 2012-RdC-ORL-Th
• Secondary ID: 2012-A00426-37
• Status: Completed
• Phase: Phase 3
• Start date: July 2013
• Est. completion date: December 8, 2020

Study information

• Verified date: July 2021
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 8, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)

2. Age = 18 years and = 75 years

3. Performance status (WHO = 2)

4. Renal, hepatic and cardiovascular functions allowing systemic treatment administration

5. Adapted stomatologic care

6. Signed informed consent form

7. Membership or beneficiary of a national insurance scheme

Exclusion Criteria:

1. Both parotids totally included in the target volume

2. Stages T1 or T2 with positive node disease N1

3. Neoadjuvant chemotherapy

4. Exereses of primitive tumor and/or nodes

5. History of other cancer within 5 years (except for basocellular epithelioma and cervical)

6. Previous neck radiotherapy

7. Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy considerations

8. Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia)incompatible with study participation

9. Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.

10. Patient already recruited in another biomedical research ( non interventional study is authorized)

11. Pregnant or breast feeding patients

12. Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection

13. Patient is deemed incapable of giving informed consent

14. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.

Related Conditions & MeSH terms

• Carcinoma
• Oropharyngeal Neoplasms
• Oropharynx Cancer
• Xerostomia

Intervention

Radiation:
• adaptative radiotherapy
weekly replanning

Locations

Country	Name	City	State
France	Clinique Claude Bernard	Albi
France	Clinique Pasteur - Saint Esprit	Brest
France	CRLCC Baclesse	Caen
France	CRLCC Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	CRLCC Antoine Lacassagne	Nice
France	CHU de la Milétrie	Poitiers
France	Centre Eugene Marquis	Rennes
France	CRLCC Henri Becquerel	Rouen
France	Centre Paul Strauss	Strasbourg
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary flow measure	The salivary flow is measured after stimulation with Parafilm at the time of inclusion and then 12 months after the end of radiotherapy.	12 months after the end of radiotherapy
Secondary	Xerostomia	salivary flow measured after stimulation before treatment, 6months, 18 months and 24 months after the end of radiotherapy Eisbruch's questionnaire before treatment, at 3, 6, 12, 18 and 24 months after the end of radiotherapy	From before treatment to 24 months after the end of radiotherapy
Secondary	Salivary flow	measured by scintigraphy	Before treatment and 12 months after the end of radiotherapy
Secondary	Local control	analysed according stages T and N, HPV status	2 years
Secondary	Early and late toxicities	early toxicity : weekly assessment during radiotherapy until 3 months after the end late toxicity : 6, 12, 18 and 24 months after the end of radiotherapy	From beginning of the radiotherapy up to 2 years after the end of radiotherapy
Secondary	Survival	overall and disease free survival	2 years
Secondary	Head and Neck functionality	MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy	Before treatment to 24 months after the end of radiotherapy