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Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC

1. marts 2016 opdateret af: Ilona Kulakiene, Lithuanian University of Health Sciences

Assessing Tumor Response and IMRT Treatment Planning After Induction Chemotherapy Based on FDG-PET/CT for Locally Advanced Head and Neck Squamous Cell Carcinoma.

To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT) based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck squamous cell carcinoma.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Current guidelines define that pre-IC target volumes must be used for radiotherapy (RT) planning. This prospective, phase II trial assessed the results of patients with locally advanced squamous cell carcinoma of head and neck treatment with IC following by chemoradiotherapy (CRT), using post-IC PET/CT images for IMRT planning.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Litauen
      • Kaunas, Litauen, LT-44307
        • Lithuanian University of Health Sciences

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female patients aged 18 years or over;
  • Histologically confirmed locally advanced (stage III and IV) head and neck squamous cell carcinoma (HNSCC);
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  • Signed written informed consent approved by the Lithuanian Bioethics Committee (LBEC);

Exclusion Criteria:

  • Positive serum pregnancy test in women of childbearing potential or breastfeeding;
  • Presence of distant metastasis;
  • Second primary tumor;
  • History of other malignancy within the last 5 years;
  • Recurrent head and neck cancer;
  • Serious uncontrolled concomitant disease that would contraindicate the use of any drugs use in this study as chemotherapy or radiotherapy; ;

  • Inadequate organ function, evidenced by the following laboratory results:

    1. Absolute neutrophil count <1,500 cells/mm3;
    2. Platelet count <100,000 cells/mm3;
    3. Hemoglobin <9 g/dL;
    4. Total bilirubin greater than the upper limit of normal (ULN);
    5. AST (SGOT) or ALT (SGPT) >1,5 x ULN;
    6. Alkaline phosphatase levels >2,5 x the ULN;
    7. Serum creatinine >2,0 mg/dl or 177 umol/l.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental
Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).
Stråling: IMRT
IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).
Andre navne:
  • intensitetsmoduleret strålebehandling
Stråling: PET/CT
Assessing tumor response using FDG-PET/CT.
Andre navne:
  • Positron-emissionstomografi-computertomografi
Medicin: Docetaxel
75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
Andre navne:
  • Taxotere, Docefrez
Medicin: Fluorouracil
750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3.
Andre navne:
  • 5-Fluorouracil, Adrucil
Medicin: Cisplatin
75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
Andre navne:
  • Platinol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression free survival (PFS)
Tidsramme: 24 months after treatment
PFS was defined as the time from the first day of IC first cycles to either progression or death.
24 months after treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tumour metabolic response (MTV) reduction (%)
Tidsramme: 2 weeks after IC
MTV was defined as the tumor volume with FDG uptake segmented by a gradient-based method and fixed threshold methods at >40% of SUVmax. The MTV predictive value for tumor response to IC was assessed by comparing MTV's reduction (MTV of second PET/CT difference from MTV of first PET/CT in percent) in IC responders versus non responders and correlation with PFS and OS.
2 weeks after IC
Total lesion glycolysis (TLG) reduction (%)
Tidsramme: 2 weeks after IC
The TLG was defined as (MTV) x (SUVmean). The TLG predictive value for tumor response to IC was assessed by comparing TLG reduction (TLG of second PET/CT difference from TLG of first PET/CT in percent) in IC responders versus non responders and correlation with PFS and OS.
2 weeks after IC
SUVmax reductions (%)
Tidsramme: 2 weeks after IC
The SUVmax was defined as (tissue activity) (mcCi/ml)/(injected dose) (mCI)/(patient weight) (kg) within the voxel having the highest activity within a given region of interest (ROI). The SUVmax predictive value for tumor response to IC was assessed by comparing reductions in SUVmax (SUVmax of second PET/CT difference from SUVmax of first PET/CT in percent) in IC responders versus non responders and correlation with PFS and OS.
2 weeks after IC
Number (%) of participants with adverse events
Tidsramme: 12 and 24 months from chemoradiotherapy
Treatment acute toxicity during IC and CRT (chemoradiotherapy) was weekly assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) v.4.0. Late adverse events related with radiotherapy were assessed every three months after CRT using RTOG (Radiation Therapy Oncology Group) /EORTC (European Organization for Research and Treatment of Cancer) toxicity criteria.
12 and 24 months from chemoradiotherapy
Overall survival (OS)
Tidsramme: 24 months after treatment
OS was defined as the time from the first day of IC first cycles until death from any cause.
24 months after treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Lithuanian University of Health Sciences

Efterforskere

  • Ledende efterforsker: Ilona Kulakiene, Prof., Lithuanian University of Health Sciences

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. juni 2013

Primær færdiggørelse (Faktiske)

1. januar 2016

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

22. januar 2014

Først indsendt, der opfyldte QC-kriterier

24. januar 2014

Først opslået (Skøn)

28. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EHNCTE-1309

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

3-7/07/2016 in ASCO (American Society of Clinical Oncology) Annual Meeting, Chicago

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 .

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