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Study to Evaluate the Response Rate to Therapy With Docetaxel and Cisplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck (DECIDE)

7. oktober 2015 opdateret af: Sanofi

Open Label, Non Controlled, Non Randomized, Interventional Study to Evaluate the Response Rate After Induction Therapy With DocEtaxel and CIsplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of heaD and nEck

Primary Objective:

To evaluate the overall response rate (including complete response and partial response) of subjects treated with combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

Secondary Objective:

To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The treatment duration for each patient will be around six months. Patients included in the study will be treated with induction regimen followed by chemo radiotherapy. Within the induction period there are three cycles (Docetaxel + Cisplatin) every 21 days, with follow-up post-induction at day 21 after cycle three. This is followed by chemoradiotherapy consisting of radiotherapy for six weeks and cisplatin every week for four weeks. The post-consolidation follow up is at eight weeks after end of chemoradiotherapy.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria :

  • Histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage III-IV without evidence of distant metastases.
  • No prior chemotherapy or radiation therapy.
  • Having at least one measurable lesion in one dimension.
  • Age ≥18 and <65 years with Eastern Cooperative Oncology Group ≤ 1.
  • Adequate organ function:
  • Adequate hematological function
  • Adequate hepatic function
  • Renal function within normal limits

Exclusion criteria:

  • Peripheral neuropathy > grade 1 or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction six months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer).
  • Being treated concomitantly with corticosteroids (except as pre-medication).
  • Patients having another type of cancer.
  • Previous chemotherapy or radiotherapy.
  • Any previous definitive surgery for squamous cell carcinoma of head and neck.
  • Severe weight loss (> 20 % of body weight) in the preceding 3 months.
  • Hearing loss (> grade 2).
  • Pregnancy (pregnancy test result for women of childbearing potential).
  • Sexually active females with lack of adequate contraception.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Docetaxel, Cisplatin

Induction:One-hour intravenous infusion of docetaxel at 75 mg/m2 followed by a 30 minute intravenous infusion of cisplatin at 75 mg/m2. All patients to be pre-medicated with oral dexamethasone at 8 mg twice daily for 3 days, commencing one day before docetaxel infusion. All patients will be premedicated with intravenous dexamethasone 20 mg to be administered before cisplatin infusion. Docetaxel and cisplatin treatments to be repeated every 21 days for three cycles.

Chemoradiotherapy (CRT): Cisplatin to be administered by 30 minutes intravenous infusion at a dose of 30 mg/m2 weekly starting concomitantly with conventional radiotherapy for a period of 6 weeks. Intravenous cisplatin to be continued for four weeks.

Radiotherapy: Gross disease dose will be 60 Gy/30 fractions and sub clinical dose 45-50 Gy/30 fractions.
Medicin: Cisplatin
Pharmaceutical form:solution Route of administration: intravenous
Medicin: DOCETAXEL XRP6976
Pharmaceutical form:solution Route of administration: intravenous
Medicin: Dexamethasone
Pharmaceutical form:tablet Route of administration: oral
Medicin: Dexamethasone
Pharmaceutical form:solution Route of administration: intravenous

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Tidsramme: Day 21 after cycle 3
Day 21 after cycle 3

Sekundære resultatmål

Resultatmål
Tidsramme
Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Tidsramme: 8 weeks after end of chemoradiotherapy
8 weeks after end of chemoradiotherapy
Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)
Tidsramme: From Day 1 cycle 1 up to Day 1 chemoradiotherapy or 30 days after the last cycle of induction therapy, whichever comes first
From Day 1 cycle 1 up to Day 1 chemoradiotherapy or 30 days after the last cycle of induction therapy, whichever comes first
Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)
Tidsramme: From Day 1 chemoradiotherapy up to or 30 days after the last day of radiotherapy
From Day 1 chemoradiotherapy up to or 30 days after the last day of radiotherapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2014

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

11. februar 2014

Først indsendt, der opfyldte QC-kriterier

11. februar 2014

Først opslået (Skøn)

13. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DOCETL06445
  • U1111-1131-0614 (Anden identifikator: UTN)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cisplatin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in New Zealand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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