Tinnitus Clinical Trials

Find Tinnitus Clinical Trials Near You

Association Between Tinnitus and Hearing Loss in Patients With Locally Advanced Head and Neck Cancer Treated by Concomitant Chemoradiotherapy or Exclusive Radiotherapy: a Prospective and Multicenter Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The aim of the AURACCO study is to evaluate the association between the onset of tinnitus and hearing loss in patients with locally advanced head and neck cancer treated by concomitant chemoradiotherapy or exclusive radiotherapy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Patient with locally advanced or post-operative ENT cancer with high risk of recurrence

• Patient ≥ 18 years

• Absence of prior chemotherapy or radiotherapy

• Patient eligible for chemotherapy with cisplatin according to the standard regimen: radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks associated with chemotherapy with cisplatin 100 mg/m2 every 3 weeks (i.e. at week 1, 4 and 7)

• Patient ineligible for cisplatin chemotherapy receiving:

‣ Either exclusive radiotherapy (age \> 70 years, contraindication: renal failure, patient wearing a device): radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks.

⁃ either chemoradiotherapy with a chemotherapy protocol different from the standard scheme (due to a contraindication to cisplatin): radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks associated with non-standard chemotherapy ototoxic (cetuximab or carboplatin-5FU)

Locations
Other Locations
France
Radiotherapy Oncology Service TENON Hospital
RECRUITING
Paris
Contact Information
Primary
Florence HUGUET, MD, PhD
Florence.huguet@aphp.fr
0033 (0) 1 56 01 62 10
Backup
Rafik NEBBACHE, Resident
Rafik.nebbache@aphp.fr
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2029-03-09
Participants
Target number of participants: 140
Treatments
Patients treated by chemoradiotherapy with high dose of cisplatin
radiotherapy 60-70 Gy in 30-35 fractions with concomitant chemotherapy by cisplatin 100 mg/m2 every 3 weeks (week 1, 3 and 7)
Patients treated with exclusive radiotherapy or radiotherapy with non-ototoxic chemotherapy
patient ineligible for chemotherapy with cisplatin:~* exclusive radiotherapy: 60-70 Gy in 30-35 fractions~* radiotherapy with a non-ototoxic chemotherapy (due to contraindication to cisplatin): 60-70 Gy in 30-35 fractions
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov