Last updated: July 26, 2023
Sponsor: Centre Francois Baclesse
Overall Status: Completed
Phase
3
Condition
Nasopharyngeal Cancer
Head And Neck Cancer
Human Papilloma Virus (Hpv)
Treatment
bandage skin Hydrotac®
Ialuset®
Clinical Study ID
NCT01520701
IPAC
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient aged 18 years old
- Carcinoma oral cavity, pharyngolaryngeal or without lymphadenopathy door
- Patient treated by one of the following diagrams
- radiotherapy alone
- postoperative radiotherapy + / - sensitized platinum (cisplatin or carboplatin)
- ar chemoradiation 5-FU and platinum (the Cetuximab is not allowed)
- diagram organ preservation (induction chemotherapy and radiotherapy inresponders)
- Untreated patients
- Patient should receive conventional radiotherapy or tomotherapy
- Adapted stomatological care
- Life expectancy > 3 months
- WHO score < 2
- Patient stable, not having the time of the examination of evidence of recurrent orprogressive malignancy other
- For patients with an indication of chemotherapy combined withradiotherapy,biological assessments compatible with chemotherapy:
- WBC > 3000/mm3, Polynuclear > 2000/mm3,Platelets > 150,000/mm3, Creatinine lessthan 2 times normal; Bilirubin less than 2.5 times normal
- Patient fluent in French
- Affiliation to a system of social security
- Patient has given written consent
Exclusion
Exclusion Criteria:
- Patient with a history of malignancy, outside a basal cell carcinoma or cervicalcancer treated and cured
- Patient has at the time of examination signs of recurrence or other neoplasia scalable
- Patient with a history of prior chemotherapy or radiation therapy with the exceptionof the scheme of organ preservation (induction chemotherapy before radiation)
- For patients with an indication of chemotherapy combined with radiotherapy,contraindication to treatment with specific platinum (cisplatin or carboplatin) withor without 5 Fluorouracil
- Infectious diseases uncontrolled
- Patient is pregnant or lactating or absence of contraception during their reproductive
- Patient hypertensive unbalanced under antihypertensive treatment
- Uncontrolled cardiac disease
- Patients with renal or hepatic
- Known allergy to any component of Ialuset ®
- Patient deprived of liberty under guardianship
- Any medical condition or psychological associate that could compromise the patient'sability to participate in the study
- Inability to undergo medical test for geographical, social or psychological
Study Design
Total Participants: 125
Treatment Group(s): 2
Primary Treatment: bandage skin Hydrotac®
Phase: 3
Study Start date:
February 01, 2012
Estimated Completion Date:
October 31, 2022
Connect with a study center
CHU
Caen, Calvados 14033
FranceSite Not Available
Centre François BACLESSE
Caen, Calvados 14076
FranceSite Not Available
Centre Maurice TUBIANA
Caen, Calvados 14000
FranceSite Not Available
Chu Rouen
Rouen, Seine Maritime 76 000
FranceSite Not Available
Centre de la Baie
Avranches,
FranceSite Not Available
Clinique Leonard de Vinci
Chambray les TOURS, 37000
FranceSite Not Available
centre hospitalier du Cotentin
Cherbourg,
FranceSite Not Available
Centre Guillaume Le Conquérant
Le Havre, 76000
FranceSite Not Available
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