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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

69

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44195
        • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
      • Cleveland, Ohio, Förenta staterna, 44106-5065
        • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / 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.
Läkemedel: cisplatin
Givet IV
Andra namn:
  • CDDP
Strålning: radiation therapy
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
Andra namn:
  • strålning
Experimentell: 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.
Läkemedel: fluorouracil
Givet IV
Läkemedel: cisplatin
Givet IV
Andra namn:
  • CDDP
Strålning: radiation therapy
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
Andra namn:
  • strålning

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Relapse Free Survival
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patterns of Failure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 12 weeks (after treatment)
12 weeks (after treatment)
Number of Patients That Required a Feeding Tube
Tidsram: 8 months after start of treatment
8 months after start of treatment
Number of Patients That Required a Feeding Tube
Tidsram: 12 months after start of treatment
12 months after start of treatment
Number of Patients That Required a Feeding Tube
Tidsram: 24 months after start of treatment
24 months after start of treatment
Nausea Level
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 24 months from start of treatment
Quality of life questionnaire asking "I have nausea".
24 months from start of treatment
Dry Mouth
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Case Comprehensive Cancer Center

Utredare

  • Huvudutredare: David J. Adelstein, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2008

Primärt slutförande (Faktisk)

1 september 2012

Avslutad studie (Faktisk)

1 augusti 2016

Studieregistreringsdatum

Först inskickad

30 januari 2008

Först inskickad som uppfyllde QC-kriterierna

31 januari 2008

Första postat (Uppskatta)

6 februari 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 augusti 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juli 2020

Senast verifierad

1 juli 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CASE3307
  • NCI-2010-01197 (Annan identifierare: NCI/CTRP)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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