Status:
COMPLETED
Comparison of Two Concomitant Administration of RT With Cisplatin in Standard Infusion or Fractional Infusion
Lead Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The general aim is to compare the cumulative dose of cisplatin administered concomitantly with radiotherapy in reference arm A (cisplatin 100 mg / m2 day 1 every 21 days) and in the experimental arm B...
Detailed Description
The standard treatment for squamous cell carcinoma of the head and neck locally advanced non-operated or non-operable is a combination of radiotherapy and concomitant chemotherapy. Indeed, the meta-an...
Eligibility Criteria
Inclusion
- Squamous cell carcinoma of head and neck cancer stage III or IV: oral cavity, oropharynx, larynx or hypopharynx.
- Patient non-operated and / or inoperable for reasons of non extirpabilité, local and regional expansion, general state or medical condition Or
- Patient operated within 8 weeks before radiation therapy with a high risk of recurrence: unsatisfactory surgical margins (R1) and / or lymph node involvement with capsular rupture.
- Activity Index according to WHO ≤ 2
- Age ≤ 70 years
- Ventricular ejection fraction left retained\> 50%
- Renal allowing the administration of cisplatin: creatinine clearance\> 60 ml / min (Cockroft formula)
- Hematologic function allowing administration of CT: PNN\> 1500, Pl\> 100000, Hb\> 9g
- Satisfactory Liver function: SGOT and SGPT \<3N; total bilirubin \<20 mg / dL; INR \<1.5; albumin\> 30 g / l
- Stomatological care adapted
- Signature of informed consent
- Bilateral neck irradiation Indication
- Women and men of reproductive age should have accepted a medically effective contraception during the treatment period and at least 6 months after discontinuation of study treatment. If pregnancy is declared by a patient or partner of a patient, it must be followed for know the evolution of pregnancy.
Exclusion
- Cancers of the nasopharynx, sinus or nasal cavities
- Histology other than squamous
- Presence of distant metastases
- Prior systemic chemotherapy (neoadjuvant)
- Other concomitant cancer therapies
- Presence of infection requiring the use of IV antibiotics including tuberculosis and HIV infection
- Coronary insufficiency, cardiac arrhythmias, uncontrolled or symptomatic heart failure
- Uncontrolled hypertension
- Peripheral neuropathy grade\> 1
- Vaccination against yellow fever and phenytoin recent or planned
- History of cancer within 5 years prior to trial entry other than cutaneous basal cell carcinoma in situ or cervical
- Pregnant woman capable of being or during lactation
- Persons deprived of liberty, under guardianship
- Inability to submit to medical monitoring testing for geographical, social or psychic
- Unilateral cervical radiotherapy Indication
Key Trial Info
Start Date :
December 3 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2021
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03330249
Start Date
December 3 2015
End Date
May 10 2021
Last Update
March 11 2022
Active Locations (1)
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1
Centre Paul Strauss
Strasbourg, France, 67065