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Lung CancerPhase 3NCT00002623

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

A Phase 3 study testing carboplatin, cisplatin and conventional surgery in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 30 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, cisplatin and conventional surgery
Type of treatment
Surgery or procedure
How many people
640 participants
Where
30 sitesin 5 countries
Study dates
Dec 1994to Dec 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

30 sites in 5 countries.

30 sites in 5 countries

Netherlands17 sites

  • Groot Ziekengasthuis 's-Hertogenbosch

    's-Hertogenbosch, 5211 NL

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1001HV

  • Antoni van Leeuwenhoekhuis

    Amsterdam, 1066 CX

  • Arnhems Radiotherapeutisch Instituut

    Arnhem, 6815 AD

  • Ziekenhuis St Jansdal

    Harderwijk, 3840 AC

  • Atrium Medical Centre

    Heerlen, 6419 PC

  • Elkerliek Ziekenhuis

    Helmond, 5707-HA

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Sint Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

  • Saint Franciscus Ziekenhuis

    Roosendaal, 4708 AE

  • University Hospital - Rotterdam Dijkzigt

    Rotterdam, 3000 CA

  • Erasmus Medical Center

    Rotterdam, 3075 EA

  • Twee Steden Ziekenhuis Vestiging Tilburg

    Tilburg, 5042 AD

  • Diakonessenhuis Utrecht

    Utrecht, 3508 TG

  • Sophia Ziekehuis

    Zwolle, 8000 GK

Other trials in Netherlands

Belgium8 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020

  • A.Z. St. Jan

    Bruges, 8000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • CHR - Clinique Saint Joseph - Hopital de Warqueguies

    Mons, B-7000

  • Clinique Universitaire De Mont-Godinne

    Mont-Godinne Yvoir, 5530

  • Stedelijk Ziekenhuis

    Roesclare, 8800

Other trials in Belgium

United Kingdom3 sites

  • Royal Victoria Hospital

    Belfast, Northern Ireland, BT12 6BA

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Royal Marsden Hospital

    Sutton, England, SM2 5PT

Other trials in United Kingdom

France1 site

  • Academisch Ziekenhuis Utrecht

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy1 site

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa (Genova), 16132

Other trials in Italy

About this study

Official title: RANDOMIZED TRIAL OF SURGERY VERSUS RADIOTHERAPY IN PATIENTS WITH STAGE IIIa NON-SMALL CELL LUNG CANCER AFTER A RESPONSE TO INDUCTION-CHEMOTHERAPY

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.

Read the 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.

Conditions
Lung Cancer
Being tested
carboplatin, cisplatin, conventional surgery, radiation therapy
Keywords
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
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 1994
  3. Primary completionDec 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
640 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002623
Sponsor's protocol ID
EORTC-08941
Other IDs
EORTC-08941
Status last verified
Jun 2012
First submitted
1 Nov 1999
Last updated
2 Jul 2012
Results posted
No

Publications

  • Van Meerbeeck JP, De Pauw R, Tournoy K. What is the optimal treatment of stage IIIA-N2 non-small-cell lung cancer after EORTC 08941? Expert Rev Anticancer Ther. 2008 Feb;8(2):199-206. doi: 10.1586/14737140.8.2.199.

    PubMed 18279061

  • van Meerbeeck JP, Kramer GW, Van Schil PE, Legrand C, Smit EF, Schramel F, Tjan-Heijnen VC, Biesma B, Debruyne C, van Zandwijk N, Splinter TA, Giaccone G; European Organisation for Research and Treatment of Cancer-Lung Cancer Group. Randomized controlled trial of resection versus radiotherapy after induction chemotherapy in stage IIIA-N2 non-small-cell lung cancer. J Natl Cancer Inst. 2007 Mar 21;99(6):442-50. doi: 10.1093/jnci/djk093.

    PubMed 17374834

  • Kramer GW, Legrand CL, van Schil P, Uitterhoeve L, Smit EF, Schramel F, Biesma B, Tjan-Heijnen V, van Zandwijk N, Splinter T, Giaccone G, van Meerbeeck JP; EORTC-Lung Cancer Group. Quality assurance of thoracic radiotherapy in EORTC 08941: a randomised trial of surgery versus thoracic radiotherapy in patients with stage IIIA non-small-cell lung cancer (NSCLC) after response to induction chemotherapy. Eur J Cancer. 2006 Jul;42(10):1391-8. doi: 10.1016/j.ejca.2006.01.052.

    PubMed 16785054

  • 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 Schil P, Van Meerbeeck J, Kramer G, Splinter T, Legrand C, Giaccone G, Manegold C, van Zandwijk N. Morbidity and mortality in the surgery arm of EORTC 08941 trial. Eur Respir J. 2005 Aug;26(2):192-7. doi: 10.1183/09031936.05.00127204.

    PubMed 16055865

  • 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, van Schil PE, Kramer GW, van Meerbeeck J, Gregor A, Rocmans P, Kirkpatrick A. Randomized trial of surgery versus radiotherapy in patients with stage IIIA (N2) non small-cell lung cancer after a response to induction chemotherapy. EORTC 08941. Clin Lung Cancer. 2000 Aug;2(1):69-72; discussion 73. doi: 10.3816/clc.2000.n.020.

    PubMed 14731343

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, cisplatin and conventional surgery in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 30 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Netherlands, Belgium, United Kingdom, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002623, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.

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