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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00002623
First received: November 1, 1999
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: cisplatin
Procedure: conventional surgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: RANDOMIZED TRIAL OF SURGERY VERSUS RADIOTHERAPY IN PATIENTS WITH STAGE IIIa NON-SMALL CELL LUNG CANCER AFTER A RESPONSE TO INDUCTION-CHEMOTHERAPY

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Estimated Enrollment: 640
Study Start Date: December 1994
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No superior vena cava syndrome

Pulmonary:

  • No diffuse interstitial pulmonary fibrosis

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for NSCLC

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for NSCLC

Surgery:

  • No prior surgery for NSCLC

Other:

  • No other prior therapy for NSCLC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002623

Locations
Belgium
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
France
Academisch Ziekenhuis Utrecht
Vandoeuvre-les-Nancy, France, 54511
Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Netherlands
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
Investigators
Study Chair: Ted A.W. Splinter, MD University Medical Center Rotterdam at Erasmus Medical Center
  More Information

Additional Information:
Publications:
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.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002623     History of Changes
Other Study ID Numbers: EORTC-08941, EORTC-08941
Study First Received: November 1, 1999
Last Updated: June 29, 2012
Health Authority: United States: Federal Government

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014