Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma

NCT01874587 | Completed Phase 3 DMC

• 2 other identifiers: 2012-RdC-ORL-Th2012-A00426-37
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 11

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.

Conditions

Oropharynx Cancer

Keywords

Adaptative radiotherapy; oropharynx carcinoma; xerostomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Xerostomia

  From before treatment to 24 months after the end of radiotherapy

• Salivary flow

  Before treatment and 12 months after the end of radiotherapy

• Local control

  2 years

• Early and late toxicities

  From beginning of the radiotherapy up to 2 years after the end of radiotherapy

• Survival

  2 years

Study Arms (2)

standard radiotherapy

NO INTERVENTION

single pre-treatment planning before radiotherapy

adaptative radiotherapy

EXPERIMENTAL

adaptive Radiotherapy based on a weekly replanning

Radiation: adaptative radiotherapy

Interventions

adaptative radiotherapy RADIATION

weekly replanning

adaptative radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Age ≥ 18 years and ≤ 75 years
• Performance status (WHO ≤ 2)
• Renal, hepatic and cardiovascular functions allowing systemic treatment administration
• Adapted stomatologic care
• Signed informed consent form
• Membership or beneficiary of a national insurance scheme

You may not qualify if:

• Both parotids totally included in the target volume
• Stages T1 or T2 with positive node disease N1
• Neoadjuvant chemotherapy
• Exereses of primitive tumor and/or nodes
• History of other cancer within 5 years (except for basocellular epithelioma and cervical)
• Previous neck radiotherapy
• Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy considerations
• Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia)incompatible with study participation
• Patient already recruited in another biomedical research ( non interventional study is authorized)
• Pregnant or breast feeding patients
• Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection
• Patient is deemed incapable of giving informed consent
• Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (11)

Clinique Claude Bernard

Albi, France

Location

Clinique Pasteur - Saint Esprit

Brest, 29200, France

Location

CRLCC Baclesse

Caen, 14076, France

Location

CRLCC Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, France

Location

CRLCC Antoine Lacassagne

Nice, 06189, France

Location

CHU de la Milétrie

Poitiers, 86000, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

CRLCC Henri Becquerel

Rouen, France

Location

Centre Paul Strauss

Strasbourg, France

Location

CHU Tours

Tours, 37044, France

Location

Related Publications (1)

• Castelli J, Thariat J, Benezery K, Hasbini A, Gery B, Berger A, Liem X, Guihard S, Chapet S, Thureau S, Auberdiac P, Pommier P, Ruffier A, Perrier L, Devillers A, Campillo-Gimenez B, de Crevoisier R. Weekly Adaptive Radiotherapy vs Standard Intensity-Modulated Radiotherapy for Improving Salivary Function in Patients With Head and Neck Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Aug 1;9(8):1056-1064. doi: 10.1001/jamaoncol.2023.1352.

  PMID: 37261806 DERIVED

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Xerostomia

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Salivary Gland Diseases; Mouth Diseases

Study Officials

• Renaud De Crevoisier, MD

  Centre Eugène Marquis - Rennes - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: June 11, 2013
• Study Start: July 1, 2013
• Primary Completion: December 10, 2019
• Study Completion: December 8, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

FR (11)