Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

14. november 2015 oppdatert av: Radiation Therapy Oncology Group

A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection for Stage IIIA (N2) Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy plus radiation therapy is more effective with or without surgery for lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combining cisplatin, etoposide, and radiation therapy with or without surgery in treating patients who have stage IIIA non-small cell lung cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Primary

  • Compare the progression-free survival, median (2-year) survival, and long-term (5-year) survival in patients with newly diagnosed, stage IIIA (N2) non-small cell lung cancer treated with radiotherapy concurrently with cisplatin and etoposide with or without surgical resection.

Secondary

  • Compare the patterns of local and distant failure in patients treated with these regimens.
  • Determine the relationship of tobacco use, alcohol use, and diet with toxicity of these regimens and outcome in both men and women.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by contralateral mediastinal sampling or biopsy (yes vs no), tumor stage (T1 vs T2 vs T3), and performance status (70-80% vs 90-100%). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive induction with cisplatin IV over 1 hour on days 1 and 8 and etoposide IV over 1 hour on days 1-5. Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning within 24 hours of the first dose of chemotherapy, patients undergo induction radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients without local progression or distant metastases at 2-4 weeks after completion of course 2 undergo resection approximately 3-5 weeks after completion of course 2. All visible, accessible bronchopulmonary, hilar, and mediastinal lymph nodes are excised. The choice of surgical procedure (thoracotomy, lobectomy, or pneumonectomy with en bloc resection of tumor extending into the parietal pleura, chest wall, pericardium, or diaphragm) is at the discretion of the surgeon. Patients who undergo resection receive 2 additional courses of chemotherapy alone beginning 4-6 weeks postoperatively. Patients with unresectable disease or who are medically unfit for or refuse resection receive 2 additional courses of chemotherapy alone beginning immediately after completion of course 2.
  • Arm II: Patients undergo induction chemoradiotherapy as in arm I but do not undergo resection. Patients without local progression or distant metastases within 1 week before anticipated completion of induction radiotherapy receive 2 additional courses of chemotherapy beginning immediately after completion of course 2. Patients without local or distant progression after completion of course 4 undergo boost radiotherapy for 8 days.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 510 patients will be accrued for this study within 4.9 years.

Studietype

Intervensjonell

Registrering (Faktiske)

429

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Illinois
      • Urbana, Illinois, Forente stater, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, Forente stater, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Iowa
      • Cedar Rapids, Iowa, Forente stater, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48106
        • CCOP - Ann Arbor Regional
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • New York
      • Rochester, New York, Forente stater, 14642
        • University of Rochester Cancer Center
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106-5065
        • Ireland Cancer Center
      • Toledo, Ohio, Forente stater, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19102-1192
        • Hahnemann University Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15213-3489
        • University of Pittsburgh Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Wisconsin
      • Green Bay, Wisconsin, Forente stater, 54301
        • CCOP - Green Bay
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)
  • Sør-Afrika
      • Pretoria, Sør-Afrika, 0001
        • Pretoria Academic Hospitals

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven newly diagnosed, stage IIIA (T1-3, N2) non-small cell lung cancer

    • Eligible subtypes:

      • Adenocarcinoma
      • Large cell carcinoma
      • Squamous cell carcinoma
      • Nonlobar and nondiffuse bronchoalveolar cell carcinoma

  • Measurable or evaluable disease on chest x-ray and/or contrast CT scan

    • Contrast thoracic CT required to complete staging
  • Single primary bronchogenic tumor (no more than 1 parenchymal lung lesion)

  • Pleural effusions allowed if 1 of the following conditions is met:

    • Negative cytology on thoracentesis if effusions present before mediastinoscopy or exploratory thoracotomy
    • Effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance

  • Positive ipsilateral mediastinal node(s) with or without positive ipsilateral hilar nodes

    • Mediastinal nodes separate from primary lesion on CT scan or surgical exploration
    • Histologic or cytologic proof of N2 disease by thoracotomy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle, or fine needle aspiration under bronchoscopic or CT guidance

    • Nodal biopsy or aspiration waived if all of the following conditions are met:

      • Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
      • Nodes visible in Level 5 region on CT scan
      • Distinct primary lesion separate from nodes on CT scan
    • All mediastinal nodal involvement mapped (positive or negative)

  • No positive nodes in contralateral mediastinum (supraclavicular areas and higher) and neck

    • Mediastinoscopy, mediastinotomy, Chamberlain procedure, or thoracotomy required for nodes larger than 1 cm on contrast CT scan
    • Surgery waived if nodes negative or no larger than 1 cm on CT scan
  • Lymphadenopathy allowed if biopsy proof of a benign cause
  • No metastases by contrast CT or MRI scan of the brain, bone scan, CT scan of the lungs to exclude other ipsilateral or contralateral parenchymal lesions, and contrast CT scan of the upper abdomen including entire liver and adrenals
  • No hepatomegaly or splenomegaly by physical examination or CT scan unless documentation of a benign cause
  • No pericardial effusion
  • No superior vena cava syndrome
  • No prior diagnosis of lung cancer

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 90-100% (70-80% allowed if albumin at least 0.85 times lower limit of normal and weight loss no greater than 10% within 3 months before diagnosis)

Hematopoietic:

  • White blood cell count (WBC) at least 4,000/mm^3 OR
  • Granulocyte count at least 2,000/mm^3
  • Platelet count normal
  • Hemoglobin at least 10.0 g/dL (less than 8.5 g/dL allowed if no marrow involvement with tumor)

Hepatic:

  • See Performance status
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
  • Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 1.5 times ULN* NOTE: * Unless documentation of a benign cause

Renal:

  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No myocardial infarction within the past 3 months
  • No active angina
  • No unstable arrhythmia
  • No congestive heart failure

Pulmonary:

  • Forced expiratory volume at one second (FEV1) at least 2.0 liters OR
  • Predicted postresection FEV1 at least 800 mL based on quantitative V/Q scan
  • Diffusion capacity of lung for carbon monoxide (DLCO) at least 50% predicted (corrected for hemoglobin) if pneumonectomy planned or likely after induction chemotherapy

Other:

  • No clinically significant hearing loss unless willing to accept the potential of further loss
  • No symptomatic peripheral neuropathy
  • No peptic ulcer disease under active treatment
  • No other medical illness not controllable by appropriate medical therapy
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent colony-stimulating factors

Chemotherapy:

  • No prior chemotherapy for lung cancer
  • No concurrent chemotherapy for another condition (such as arthritis)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for lung cancer

Surgery:

  • See Disease Characteristics
  • No prior resection of primary tumor

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: RT + chemotherapy followed by surgery + chemotherapy
Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
Stråling: strålebehandling
Legemiddel: etoposid
Legemiddel: cisplatin
Fremgangsmåte: konvensjonell kirurgi
Aktiv komparator: RT + chemotherapy followed by chemotherapy + RT
Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
Stråling: strålebehandling
Legemiddel: etoposid
Legemiddel: cisplatin

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Median overall survival
Tidsramme: From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.
From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.

Sekundære resultatmål

Resultatmål
Tidsramme
Median Progression-free survival
Tidsramme: From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.
From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.
Patterns of local and distant failure
Tidsramme: From randomization to date of failure (local, regional or distant progression). Analysis occurs after patients have been potentially followed for 2.5 years.
From randomization to date of failure (local, regional or distant progression). Analysis occurs after patients have been potentially followed for 2.5 years.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Radiation Therapy Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
Cancer and Leukemia Group B
North Central Cancer Treatment Group

Etterforskere

  • Studiestol: Robert C. Miller, MD, Mayo Clinic
  • Studiestol: David S. Ettinger, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Studiestol: David H. Johnson, MD, Vanderbilt-Ingram Cancer Center
  • Hovedetterforsker: Kathy S. Albain, MD, Loyola University
  • Studiestol: Bruce E. Johnson, MD, Dana-Farber Cancer Institute
  • Studiestol: Mark R. Green, MD, Medical University of South Carolina
  • Studiestol: Yvon Cormier, MD, L'Hopital Laval

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 1994

Primær fullføring (Faktiske)

1. juni 2004

Studiet fullført (Faktiske)

1. november 2013

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

9. april 2003

Først lagt ut (Anslag)

10. april 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. november 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. november 2015

Sist bekreftet

1. november 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RTOG-9309
  • CDR0000063333
  • CAN-NCIC-BR13
  • CLB-9592
  • E-R9309
  • NCCTG-R9309
  • NCI-94-C-0043
  • SWOG-9336
  • INT-0139

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere