Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma

NCT ID: NCT01874587

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2020-12-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard radiotherapy

single pre-treatment planning before radiotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

adaptative radiotherapy

adaptive Radiotherapy based on a weekly replanning

Group Type: EXPERIMENTAL

adaptative radiotherapy

Intervention Type: RADIATION

weekly replanning

Interventions

adaptative radiotherapy

weekly replanning

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center Eugene Marquis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renaud De Crevoisier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Eugène Marquis - Rennes - France

Locations

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, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37261806 (View on PubMed)

Other Identifiers

2012-A00426-37

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-RdC-ORL-Th

Identifier Type: -

Identifier Source: org_study_id