Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma

Phase 3

Completed

• Conditions: Oropharynx Cancer
• Interventions: Radiation: adaptative radiotherapy

• Registration Number: NCT01874587
• Lead Sponsor: Center Eugene Marquis

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-25
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Study Start: 2013-07
• Primary Completion: 2019-12-10
• Study Completion: 2020-12-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adaptative radiotherapy	adaptative radiotherapy	adaptive Radiotherapy based on a weekly replanning

Primary Outcome Measures

Name	Time	Method
Salivary flow measure	12 months after the end of radiotherapy	The salivary flow is measured after stimulation with Parafilm at the time of inclusion and then 12 months after the end of radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Xerostomia	From before treatment to 24 months after the end of radiotherapy	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
Salivary flow	Before treatment and 12 months after the end of radiotherapy	measured by scintigraphy
Survival	2 years	overall and disease free survival
Local control	2 years	analysed according stages T and N, HPV status
Early and late toxicities	From beginning of the radiotherapy up to 2 years after the end of radiotherapy	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
Head and Neck functionality	Before treatment to 24 months after the end of radiotherapy	MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy

Trial Locations

Locations (11)

Clinique Claude Bernard; 🇫🇷 Albi, France

Clinique Pasteur - Saint Esprit; 🇫🇷 Brest, France

CRLCC Oscar Lambret; 🇫🇷 Lille, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

CHU de la Milétrie; 🇫🇷 Poitiers, France

CRLCC Henri Becquerel; 🇫🇷 Rouen, France

CHU Tours; 🇫🇷 Tours, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CRLCC Baclesse; 🇫🇷 Caen, France

CRLCC Antoine Lacassagne; 🇫🇷 Nice, France