Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002623
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy followed by surgery with or without radiation therapy is more effective than chemotherapy followed by radiation therapy alone in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by surgery with or without radiation therapy to that of chemotherapy followed by radiation therapy alone in treating patients who have stage III non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: cisplatin Procedure: conventional surgery Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the overall survival of patients with stage IIIA non-small cell lung cancer treated with surgery with or without radiotherapy versus radiotherapy alone after achieving a response to a neoadjuvant chemotherapy regimen containing cisplatin or carboplatin.
  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, response to induction chemotherapy (complete vs partial vs minor), and histological subtype (squamous vs nonsquamous).

All patients receive 3 courses of induction combination chemotherapy comprising cisplatin or carboplatin in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response (or minor response if disease has become resectable) are randomized to 1 of 2 treatment arms.

  • Arm I: Within 6 weeks of randomization, patients undergo radical lobectomy or pneumonectomy plus dissection of the hilar and mediastinal lymph nodes.

Patients with positive resection margins of at least 1 cm and/or positive mediastinal nodes undergo radiotherapy 5 days a week for 5.5 weeks.

Patients with postresection subclinical/microscopic disease with negative tumor margins undergo radiotherapy 5 days a week for 4-4.5 weeks.

  • Arm II: Within 6 weeks of randomization, patients undergo primary radiotherapy. Patients with subclinical/microscopic disease with negative tumor margins undergo radiotherapy 5 days a week for 4-4.5 weeks.

Patients with gross tumor volume and tumor margins at least 1 cm undergo radiotherapy 5 days a week for 6 weeks.

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

PROJECTED ACCRUAL: A total of 640 patients will be accrued for this study within 8 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : December 1994
Actual Primary Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically proven primary unresectable non-small cell lung cancer (NSCLC) by mediastinoscopy, mediastinotomy, thoracotomy, video-assisted thoracic surgery, or needle biopsy

    • Stage IIIA (N2) disease by chest CT scan
    • Any histologic subtype allowed
  • At least 1 unidimensionally or bidimensionally measurable target lesion on chest CT scan
  • No N3 or metastatic disease by physical exam, CT scan of thorax, bone scan, and CT scan or ultrasound of liver and adrenals
  • No pre-existing pleural or pericardial effusion
  • No symptomatic CNS involvement



  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No superior vena cava syndrome


  • No diffuse interstitial pulmonary fibrosis


  • No prior melanoma, breast cancer, or hypernephroma
  • No other primary malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No grade 2 or greater pre-existing motor or sensory neurotoxicity
  • No active uncontrolled infection requiring IV antibiotics
  • Must be physically and mentally fit for study therapy
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • No prior chemotherapy for NSCLC

Endocrine therapy:

  • Not specified


  • No prior radiotherapy for NSCLC


  • No prior surgery for NSCLC


  • No other prior therapy for NSCLC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002623

Algemeen Ziekenhuis Middelheim
Antwerp, Belgium, 2020
A.Z. St. Jan
Brugge, Belgium, 8000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
CHR - Clinique Saint Joseph - Hopital de Warqueguies
Mons, Belgium, B-7000
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, Belgium, 5530
Stedelijk Ziekenhuis
Roesclare, Belgium, 8800
Academisch Ziekenhuis Utrecht
Vandoeuvre-les-Nancy, France, 54511
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, Netherlands, 5211 NL
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1001HV
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Arnhems Radiotherapeutisch Instituut
Arnhem, Netherlands, 6815 AD
Ziekenhuis St Jansdal
Harderwijk, Netherlands, 3840 AC
Atrium Medical Centre
Heerlen, Netherlands, 6419 PC
Elkerliek Ziekenhuis
Helmond, Netherlands, 5707-HA
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands, 6532 SZ
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Saint Franciscus Ziekenhuis
Roosendaal, Netherlands, 4708 AE
University Hospital - Rotterdam Dijkzigt
Rotterdam, Netherlands, 3000 CA
Erasmus Medical Center
Rotterdam, Netherlands, 3075 EA
Twee Steden Ziekenhuis Vestiging Tilburg
Tilburg, Netherlands, 5042 AD
Diakonessenhuis Utrecht
Utrecht, Netherlands, 3508 TG
Sophia Ziekehuis
Zwolle, Netherlands, 8000 GK
United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Royal Victoria Hospital
Belfast, Northern Ireland, United Kingdom, BT12 6BA
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Ted A.W. Splinter, MD University Medical Center Rotterdam at Erasmus Medical Center

Publications of Results:
Van Meerbeeck JP, Kramer GW, Legrand C, et al.: Does downstaging in patients (pts) with IIIA-N2 non-small cell lung cancer (NSCLC) and a response to induction chemotherapy (ICT) influence outcome with surgery (S) or radiotherapy (RT)? An exploratory analysis of EORTC 08941. [Abstract] J Clin Oncol 24 (Suppl 18): A-7047, 375s, 2006.
Van Meerbeeck JP, Kramer G, Van Schil PE, et al.: A randomized trial of radical surgery (S) versus thoracic radiotherapy (TRT) in patients (pts) with stage IIIA-N2 non-small cell lung cancer (NSCLC) after response to induction chemotherapy (ICT) (EORTC 08941). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7015, 624s, 2005.
van Meerbeeck JP, Kramer GWPM, van Schil PEY, et al.: Induction chemotherapy (CT) in stage IIIA-N2 non-small cell lung cancer (NSCLC):an analysis of different regimens used in EORTC 08941. [Abstract] Lung Cancer 41 (Suppl 2): A-O-273, S79, 2003.
van Schil PE, van Meerbeeck JP, Kramer G, et al.: Surgery after induction chemotherapy: morbidity and mortality in the first 100 patients of the surgery arm of EORTC 08941 trial. [Abstract] Lung Cancer 41 (Suppl 2): A-O-147, S45, 2003.
Splinter TA, Kirkpatrick A, Van Meerbeeck J, et al.: Randomized trial of surgery versus radiotherapy in patients with stage IIIA non-small cell lung cancer after a response to induction chemotherapy. Intergroup study 08941. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1742, 453a, 1998.

Other Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00002623     History of Changes
Other Study ID Numbers: EORTC-08941
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
squamous cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents