- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00352118
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Minnesota
-
Minneapolis, Minnesota, Stany Zjednoczone, 55455
- Masonic Cancer Center at University of Minnesota
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
|
subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
Inne nazwy:
If applicable on day 5, repeating every 3 weeks for 2 courses.
Inne nazwy:
Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
Inne nazwy:
Intravenous over 1 hour on day 1.
Inne nazwy:
Intravenous continuously on days 1-4.
Inne nazwy:
As appropriate, neck dissection.
Inne nazwy:
60 Gy 5 days/week x 6 weeks with cisplatin
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Number of Patients With Feeding Tube Dependency
Ramy czasowe: at 12 months
|
All patients were non-evaluable and study was terminated early.
There is no measure of outcome.
|
at 12 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Number of Days With Progression-free Survival
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
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Swallowing Ability - Quality of Life Scores
Ramy czasowe: 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.
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Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire
Ramy czasowe: 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
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Frank G. Ondrey, MD, PhD, Masonic Cancer Center, University of Minnesota
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
- Rak płaskonabłonkowy wargi i jamy ustnej w III stopniu zaawansowania
- Rak płaskonabłonkowy wargi i jamy ustnej IV stopnia
- rak płaskonabłonkowy jamy ustnej i gardła w III stopniu zaawansowania
- Rak płaskonabłonkowy jamy ustnej i gardła w IV stopniu zaawansowania
- rak płaskonabłonkowy gardła III stopnia
- rak płaskonabłonkowy gardła IV stopnia
- rak płaskonabłonkowy krtani w III stopniu zaawansowania
- Rak płaskonabłonkowy krtani w IV stopniu zaawansowania
- zapalenie błony śluzowej
- kserostomia
- jamy ustnej powikłania radioterapii
- oral complications of chemotherapy
Dodatkowe istotne warunki MeSH
- Nowotwory
- Nowotwory według lokalizacji
- Nowotwory głowy i szyi
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Antymetabolity, przeciwnowotworowe
- Antymetabolity
- Środki przeciwnowotworowe
- Środki immunosupresyjne
- Czynniki immunologiczne
- Modulatory tubuliny
- Środki antymitotyczne
- Modulatory mitozy
- Adiuwanty, immunologiczne
- Docetaksel
- Cisplatyna
- Fluorouracyl
- Lenograstym
Inne numery identyfikacyjne badania
- 2005LS012
- UMN-0502M67486
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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