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Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

3. december 2017 opdateret af: Masonic Cancer Center, University of Minnesota

Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy.

Secondary

  • Determine the progression-free, disease-free, and overall survival of patients treated with this regimen.
  • Determine the pattern of failure in patients treated with this regimen.
  • Evaluate the quality of life of patients treated with this regimen.
  • Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life.

Tertiary

  • Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
  • Evaluate the quality of saliva by examining total protein concentrations.
  • Quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients.
  • Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
  • Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.

OUTLINE: This is a pilot study.

  • Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later.
  • Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks.
  • Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection.

Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia.

Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Masonic Cancer Center at University of Minnesota

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the head and neck

    • Stage IVA or IVB disease

      • Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
  • Measurable or evaluable disease
  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
  • Bilirubin normal

  • Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:

    • AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST or ALT normal

Exclusion Criteria:

  • Salivary gland, sinus, or nasopharyngeal primary disease
  • Evidence of distant metastatic disease
  • Pregnant or nursing
  • Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
  • Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
  • Peripheral neuropathy ≥ grade 2
  • Hearing loss ≥ grade 2
  • Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
  • Poor nutritional status, in the opinion of the investigator
  • Active infection
  • Active ischemic heart disease
  • Myocardial infarction within the past 6 months
  • Prior radiotherapy above the clavicles
  • Prior chemotherapy
  • Prior surgery to the primary tumor except biopsy
  • Concurrent amifostine or other investigational agents

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: Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
Biologisk: filgrastim
subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
Andre navne:
  • G-CSF
  • Neupogen
Biologisk: pegfilgrastim
If applicable on day 5, repeating every 3 weeks for 2 courses.
Andre navne:
  • Neulasta, G-CSF
Medicin: cisplatin
Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
Andre navne:
  • CDDP
  • cisplatin
  • Platinol AQ
  • cis-diamminedichloridoplatinum
Medicin: docetaxel
Intravenous over 1 hour on day 1.
Andre navne:
  • Taxotere(R)
Medicin: fluorouracil
Intravenous continuously on days 1-4.
Andre navne:
  • 5-FU
  • 5-fluoruracil
  • Adrucil
Procedure: conventional surgery
As appropriate, neck dissection.
Andre navne:
  • kirurgi
Stråling: radiation therapy
60 Gy 5 days/week x 6 weeks with cisplatin
Andre navne:
  • stråling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients With Feeding Tube Dependency
Tidsramme: at 12 months
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
at 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Days With Progression-free Survival
Tidsramme: Between date of registration to date of first treatment failure or death.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Between date of registration to date of first treatment failure or death.
Number of Days - Overall Survival
Tidsramme: Between date of registration to date of death.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Between date of registration to date of death.
Number of Days With Disease Free Survival
Tidsramme: From Date of Registration to Date of First Treatment Failure or Death
All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.
From Date of Registration to Date of First Treatment Failure or Death
Time to Treatment Failure
Tidsramme: Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.
Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
Swallowing Ability - Quality of Life Scores
Tidsramme: Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).
Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire
Tidsramme: baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Masonic Cancer Center, University of Minnesota

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Frank G. Ondrey, MD, PhD, Masonic Cancer Center, University of Minnesota

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. marts 2006

Primær færdiggørelse (Faktiske)

1. april 2008

Studieafslutning (Faktiske)

1. april 2008

Datoer for studieregistrering

Først indsendt

13. juli 2006

Først indsendt, der opfyldte QC-kriterier

13. juli 2006

Først opslået (Skøn)

14. juli 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2005LS012
  • UMN-0502M67486

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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