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

3. Dezember 2017 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

4

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55455
        • Masonic Cancer Center at University of Minnesota

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
Biologisch: filgrastim
subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
Andere Namen:
  • G-CSF
  • Neupogen
Biologisch: pegfilgrastim
If applicable on day 5, repeating every 3 weeks for 2 courses.
Andere Namen:
  • Neulasta, G-CSF
Arzneimittel: cisplatin
Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
Andere Namen:
  • CDDP
  • Cisplatin
  • Platinol AQ
  • cis-diamminedichloridoplatinum
Arzneimittel: docetaxel
Intravenous over 1 hour on day 1.
Andere Namen:
  • Taxotere®
Arzneimittel: fluorouracil
Intravenous continuously on days 1-4.
Andere Namen:
  • 5-FU
  • 5-Fluorouracil
  • Adrucil
Verfahren: conventional surgery
As appropriate, neck dissection.
Andere Namen:
  • Chirurgie
Strahlung: radiation therapy
60 Gy 5 days/week x 6 weeks with cisplatin
Andere Namen:
  • Strahlung

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Days With Progression-free Survival
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Masonic Cancer Center, University of Minnesota

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2006

Primärer Abschluss (Tatsächlich)

1. April 2008

Studienabschluss (Tatsächlich)

1. April 2008

Studienanmeldedaten

Zuerst eingereicht

13. Juli 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juli 2006

Zuerst gepostet (Schätzen)

14. Juli 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Dezember 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Dezember 2017

Zuletzt verifiziert

1. Dezember 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2005LS012
  • UMN-0502M67486

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