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Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer

23. juli 2020 opdateret af: Case Comprehensive Cancer Center

A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as 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. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • To compare the relapse-free survival of patients treated with radiotherapy and cisplatin with vs without fluorouracil.
  • To compare the overall survival, local control without surgery, and patterns of failure in patients treated with these regimens.
  • To compare the acute and long-term toxicity of these regimens in these patients.
  • To compare the quality of life of patients treated with these regimens.
  • To prospectively collect biopsy material, mucosal scrapings, and serum in an effort to generate hypotheses for future correlative studies.

OUTLINE: This is a multicenter study. Patients are stratified according to radiotherapy schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs intensity-modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
  • Arm II: Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Patients with biopsy-verified residual disease at the primary site or local recurrence after achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks after the completion of chemoradiotherapy.

Patients complete questionnaires periodically to assess late toxicity and quality of life.

After completion of study treatment, patients are followed periodically.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

69

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

    • No histologic diagnosis other than squamous cell carcinoma
    • A primary site must be identified

  • Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease

    • No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0)
    • No stage IVC disease (stage IVB disease allowed)

  • Deemed appropriate for definitive non-operative management with curative intent

    • Resectable disease is not required
  • No primary cancer of the nasopharynx, paranasal sinus, or salivary gland

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC > 3,500/mm³
  • Platelet count > 100,000/mm³
  • Serum creatinine < 2.0 mg/dL
  • Alkaline phosphatase < 2 times normal
  • AST < 2 times normal
  • Bilirubin ≤ 2.0 mg/dL
  • Serum calcium normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No unstable or uncontrolled angina
  • No clinically apparent jaundice
  • No active infection
  • No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years
  • Not a poor compliance risk
  • Able to withstand the rigors of intensive treatment
  • Available for and compliant with adequate long-term follow-up

PRIOR CONCURRENT THERAPY:

  • No prior definitive surgery or radiotherapy for this malignancy
  • No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible.

Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible.

Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible.

Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years.

Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.

Patients who might be a poor-compliance risk are ineligible.

Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm A: Radiation with concurrent Cisplatin
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Medicin: cisplatin
Givet IV
Andre navne:
  • CDDP
Stråling: radiation therapy
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
Andre navne:
  • stråling
Eksperimentel: Arm B: Radiation with concurrent 5-FU and Cisplatin
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Medicin: fluorouracil
Givet IV
Medicin: cisplatin
Givet IV
Andre navne:
  • CDDP
Stråling: radiation therapy
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
Andre navne:
  • stråling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relapse Free Survival
Tidsramme: at 2 yrs from start of study
Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..
at 2 yrs from start of study

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patterns of Failure
Tidsramme: 2 years from start of study
Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.
2 years from start of study
Overall Survival
Tidsramme: 2 yrs from start of study
Number of patients still alive from 2 years from start of study
2 yrs from start of study
Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
Tidsramme: at 12 weeks after completing chemoradiotherapy
Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.
at 12 weeks after completing chemoradiotherapy
Number of Patients With a Pathological(Final)Complete Response
Tidsramme: at 12 weeks after completing chemoradiotherapy and surgery
A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.
at 12 weeks after completing chemoradiotherapy and surgery
Disease Recurrence
Tidsramme: 2 years after start of study
Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.
2 years after start of study
Number of Patients That Required a Feeding Tube
Tidsramme: 12 weeks (after treatment)
12 weeks (after treatment)
Number of Patients That Required a Feeding Tube
Tidsramme: 8 months after start of treatment
8 months after start of treatment
Number of Patients That Required a Feeding Tube
Tidsramme: 12 months after start of treatment
12 months after start of treatment
Number of Patients That Required a Feeding Tube
Tidsramme: 24 months after start of treatment
24 months after start of treatment
Nausea Level
Tidsramme: 12 weeks (after treatment)

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).

N (number of patients analyzed) is based on number of patients who completed the question.
12 weeks (after treatment)
Nausea Level
Tidsramme: 8 months from start of treatment

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Nausea Level
Tidsramme: 12 months from start of treatment

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Nausea Level
Tidsramme: 24 months from start of treatment
Quality of life questionnaire asking "I have nausea".
24 months from start of treatment
Dry Mouth
Tidsramme: 12 weeks (after treatment)

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Dry Mouth
Tidsramme: 8 months from start of treatment

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Dry Mouth
Tidsramme: 12 months from start of treatment

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Dry Mouth
Tidsramme: 24 months from start of treatment

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months from start of treatment
Pain
Tidsramme: 12 weeks (after treatment)

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Pain
Tidsramme: 8 months from start of treatment

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Pain
Tidsramme: 12 months from start of treatment

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Pain
Tidsramme: 24 months from start of treatment

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months from start of treatment
Quality of Life
Tidsramme: 12 weeks (after treatment)

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Quality of Life
Tidsramme: 8 months from start of treatment

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Quality of Life
Tidsramme: 12 months from start of treatment

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Quality of Life
Tidsramme: 24 months from start of treatment

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months from start of treatment
Eating
Tidsramme: 12 weeks (after treatment)

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Eating
Tidsramme: 8 months from start of treatment

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Eating
Tidsramme: 12 months from start of treatment

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Eating
Tidsramme: 24 months from start of treatment

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months from start of treatment
Swallowing
Tidsramme: 12 weeks (after treatment)

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Swallowing
Tidsramme: 8 months after start of treatment

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months after start of treatment
Swallowing
Tidsramme: 12 months after start of treatment

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months after start of treatment
Swallowing
Tidsramme: 24 months after start of treatment

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months after start of treatment
Alcohol Consumption
Tidsramme: 12 weeks (after treatment)

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Alcohol Consumption
Tidsramme: 8 months after start of treatment

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months after start of treatment
Alcohol Consumption
Tidsramme: 12 months after start of treatment

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months after start of treatment
Alcohol Consumption
Tidsramme: 24 months after start of treatment

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months after start of treatment
Solid Foods
Tidsramme: 12 weeks (after treatment)

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Solid Foods
Tidsramme: 8 months after start of treatment

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months after start of treatment
Solid Foods
Tidsramme: 12 months after start of treatment

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months after start of treatment
Solid Foods
Tidsramme: 24 months after start of treatment

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months after start of treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Case Comprehensive Cancer Center

Efterforskere

  • Ledende efterforsker: David J. Adelstein, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

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. januar 2008

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

30. januar 2008

Først indsendt, der opfyldte QC-kriterier

31. januar 2008

Først opslået (Skøn)

6. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CASE3307
  • NCI-2010-01197 (Anden identifikator: NCI/CTRP)

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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Betingelser

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Placeringer

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