Comparison of Two Concomitant Administration of RT With Cisplatin in Standard Infusion or Fractional Infusion

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 (Cisplatin split 25 mg / m2 / J D1 to D4 all 21 days).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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