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

NCT03330249 | Completed Phase 2 DMC

• 1 other identifier: GORTEC 2015-02
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• cumulative dose of administered cisplatin in each arm

  cisplatin dose amount received at each cycle

  36 months after the end of treatment

Secondary Outcomes (8)

• Frequency of toxicities

  Every week during treatment and every 3 months after treatment up to 3 years

• Maximum Platine Concentration [Cmax],

  Cycle 1 before infusion, 90 min, 180 min,210 min, 270 min, 360 min and 420 min after the beginning of infusion in comparator arm and before infusion, 30 min, 45 min,75 min, 135 min, 225 min in experimental arm at Day 1 and Day 4

• Area Under the Curve [AUC] of platine

  Cycle 1 before infusion, 90 min, 180 min, 210 min, 270 min, 360 min and 420 min after the beginning of infusion in comparator arm and before infusion, 30 min, 45 min, 75 min, 135 min, 225 min in experimental arm at Day 1 and Day 4

• Values of Neutrophil Gélatinase-associated Lipocalin (NGAL)

  Baseline and 24hour after infusion of cisplatin in comparator arm and 24hour after the last infusion of cisplatin in experimental arm

• Doses of radiation

  7 weeks after the beginning of radiotherapy

Study Arms (2)

Split Cisplatin and radiotherapy

EXPERIMENTAL

25 mg/m2/day IV infusion at D1 to D4, at D22 to D25, at D43 to D46 during the radiotherapy

Drug: Split Cisplatin; Radiation: Radiotherapy

Cisplatin and radiotherapy

ACTIVE COMPARATOR

100 mg/m2/day IV infusion at D1, D22 and D43 during the radiotherapy

Drug: Cisplatin; Radiation: Radiotherapy

Interventions

Split Cisplatin DRUG

25 mg/m2/day IV infusion at D1 to D4, at D22 to D25, at D43 to D46 during the radiotherapy.

Also known as: Cisplatin infusion

Split Cisplatin and radiotherapy

Cisplatin DRUG

100 mg/m2/day IV infusion at D1, D22 and D43 during the radiotherapy.

Also known as: Cisplatin infusion

Cisplatin and radiotherapy

Radiotherapy RADIATION

70 Gy in 35 fractions of 2 Gy in non-operated patients and 66 Gy in 33 fractions in post-operative.

Also known as: Radiotherapy IMRT with possibly integrated boost

Cisplatin and radiotherapy; Split Cisplatin and radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead

Study Sites (1)

Centre Paul Strauss

Strasbourg, 67065, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• Christian BOREL, MD

  Centre Paul Strauss

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: November 6, 2017
• Study Start: December 3, 2015
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)