Clinical trial · Interventional
Comparison of Two Concomitant Administration of RT With Cisplatin in Standard Infusion or Fractional Infusion
Phase II Randomized Trial Comparating Two Concomitant Administration of Radiotherapy With Cisplatin in Patients With Not Operated or Inoperable HNSCC or With Recurrence High Risk in Adjuvant Postoperative Treatment
NCT03330249CI-TRIAL-00057046CisFRadcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Split Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Split Cisplatin and radiotherapy
- description
- 25 mg/m2/day IV infusion at D1 to D4, at D22 to D25, at D43 to D46 during the radiotherapy
- interventionNames
- Drug: Split Cisplatin
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin and radiotherapy
- description
- 100 mg/m2/day IV infusion at D1, D22 and D43 during the radiotherapy
- interventionNames
- Drug: Cisplatin
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- cumulative dose of administered cisplatin in each arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.