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Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC

13. maj 2019 opdateret af: Swiss Group for Clinical Cancer Research

Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer.
  • Determine the rate of event-free survival at 1 year in patients treated with this regimen.
  • Determine the operability and complete resection rate in patients treated with this regimen.
  • Determine the postoperative 30-day mortality in patients treated with this regimen.
  • Determine the response rate, failure pattern, and overall survival in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.

Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.

Patients undergo surgery within 3-4 weeks after completion of radiotherapy.

Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

46

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

      • Lausanne, Schweiz, CH-1011
        • Centre Hospitalier Universitaire Vaudois

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed, operable stage IIIB non-small cell lung cancer

    • T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for assessment of N3 disease) or CT scan or MRI of the thorax
    • Squamous cell
    • Adenosquamous cell
    • Large cell
    • Poorly differentiated
  • No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan, and abdominal ultrasound or CT scan
  • No malignant pleural or pericardial effusion
  • No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • AST and/or ALT no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No unstable cardiac disease requiring treatment
  • No congestive heart failure
  • No angina pectoris (even if medically controlled)
  • No significant arrhythmia
  • No myocardial infarction within the past 3 months

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No definite contraindications for the use of corticosteroids as premedication
  • No preexisting grade 2 or greater peripheral neuropathy
  • No active uncontrolled infection
  • No uncontrolled diabetes mellitus
  • No other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix
  • No prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent
  • No other serious underlying medical condition that would preclude study participation
  • No socioeconomic or geographical circumstances that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent)

Radiotherapy:

  • No prior radiotherapy to the chest

Surgery:

  • See Disease Characteristics

Other:

  • At least 30 days since prior treatment in a clinical trial
  • No prior cytostatic therapy
  • No other concurrent experimental drugs

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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Rate of event-free survival measured 1 year after registration

Sekundære resultatmål

Resultatmål
Toksicitet
Svarprocent
Operability after chemotherapy
Postoperative mortality 30 days after surgery
Complete resection rate after surgery

Samarbejdspartnere og efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. september 2001

Primær færdiggørelse (Faktiske)

1. maj 2006

Studieafslutning (Faktiske)

1. maj 2006

Datoer for studieregistrering

Først indsendt

14. februar 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2019

Sidst verificeret

1. maj 2019

Mere information

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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