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Lung CancerPhase 3NCT00005062

Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission

A Phase 3 study testing radiation therapy in people with Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 93 sites in 28 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: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain. Read more about this study

Who is it for?
Ages Up to 70 years
Conditions the study is for
Lung Cancer
What is being tested?
radiation therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
93 sitesin 28 countries
Study dates
Sep 1999to Dec 2005
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 Up to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven limited stage small cell lung cancer
  • Complete response to induction therapy (at least on chest x-ray)
  • Normal brain CT scan or MRI less than 1 month prior to study
  • No metastases (including ipsilateral lung metastases and malignant pleural effusion)

PATIENT CHARACTERISTICS:

Age:

  • 70 and under

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No prior cerebrovascular disease

Other:

  • No epilepsy requiring permanent oral medication
  • No other prior malignancy except skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy:

  • Concurrent steroids allowed

Radiotherapy:

  • Concurrent thoracic radiotherapy allowed

Surgery:

  • Not specified

Other

  • No other concurrent antitumoral agent

Trial locations and contacts

93 sites in 28 countries.

93 sites in 28 countries

France33 sites

  • Clinique De Rochebelle

    Alès, F-30100

  • Centre de Traitement Hautes - Energies

    Amiens, 80000

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • C.H.G. Beauvais

    Beauvais, 60000

  • Polyclinique Bordeaux Nord Aquitaine

    Boucher, 33300

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre de Radiotherapie

    Compiègne, 60200

  • Centre Hospitalier Sud Francilien - Site Corbeil

    Corbeil, 91100

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94010

  • Hopital Intercommunal De Creteil

    Créteil, 94010

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre De Radiotherapie Charlebourg

    La Garenne-Colombes, 92250

  • Centre Guillaume Le Conquerant

    Le Havre, 76600

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • C.R.T.T.

    Meudon-la-Forêt, 92360

  • C.H. General De Montbelliard

    Montbelliard, 25200

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45067

  • Institut Curie - Section Medicale

    Paris, 75005

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Institut Jean Godinot

    Reims, 51056

  • Centre Frederic Joliot

    Rouen, 76000

  • Centre du Rouget

    Sarcelles, 95250

  • Centre Hospitalier Prive Des Yvelines

    Sartrouville, 78500

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67100

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151

  • Hopital d'Instruction des Armes Sainte-Anne

    Toulon, 83800

  • Centre d'Oncologie Saint-Yves

    Vannes, 56001

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

United Kingdom12 sites

  • Velindre Cancer Center at Velinde Hospital

    Cardiff, CF4 7XL

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Beatson Oncology Centre

    Glasgow, Scotland, G11 6NT

  • Nevill Hall Hospital

    Gwent, Wales

  • Raigmore Hospital

    Inverness, Scotland, 1V2 3UJ

  • Christie Hospital N.H.S. Trust

    Manchester, England, M20 4BX

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Royal Gwent Hospital

    Newport Gwent, Wales, NP9 2UB

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, S10 2SJ

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

Other trials in United Kingdom

Belgium6 sites

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerp, 2020

  • Universiteit Gent

    Ghent, B-9000

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • Cazk Groeninghe - Campus Maria's Voorzienigheid

    Kortrijk, B-8500

  • Clinique Saint-Joseph

    Liège, B 4000

  • Clinique Sainte Elisabeth

    Namur, 50000

Other trials in Belgium

Greece5 sites

  • Evaggelismos Hospital

    Athens, 10676

  • Sotiria Hospital Chest Diseases

    Athens

  • University Hospital of Heraklion

    Heraklion, Crete, 71110

  • Venizelion Gr.

    Heraklion, 71306

  • University of Patras Medical School

    Rio Patras, GR-26500

Other trials in Greece

Netherlands4 sites

  • Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum

    Amsterdam, 1007 MB

  • Arnhems Radiotherapeutisch Instituut

    Arnhem, 6815 AD

  • Nijmegen Cancer Center at Radboud University Medical Center

    Nijmegen, 6500 HB

  • University Medical Center Rotterdam at Erasmus Medical Center

    Rotterdam, 3000 CA

Other trials in Netherlands

Poland4 sites

  • Medical University of Gdansk

    Gdansk, 80 211

  • Institute of Oncology

    Lodz, 93509

  • Regional Lung Diseases Hospital

    Poznan, 60 569

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02 781

Other trials in Poland

Italy3 sites

  • Ospedale Bellaria

    Bologna, I-40139

  • Universita Degli Studi Di Pisa

    Pisa, 56126

  • Ospedale Ostetrico Ginecologica Sant Anna

    Turin, 10126

Other trials in Italy

Australia2 sites

  • Cancer Therapy Centre at Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Radiation Oncology Victoria

    East Melbourne, Victoria, 3002

Other trials in Australia

Chile2 sites

  • Instituto de Radiomedicina

    Santiago, 10

  • Clinica Renaca - Gocchi

    Viña del Mar

Other trials in Chile

Czechia2 sites

  • Masaryk Memorial Cancer Institute

    Brno, 656 53

  • First Medical Clinic of Charles University Hospital

    Prague, 128 08

Other trials in Czechia

Israel2 sites

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Spain2 sites

  • Hospital Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital Virgen de las Nieves

    Granada, 18014

Other trials in Spain

United States1 site

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

Other trials in United States

Brazil1 site

  • Instituto Nacional de Cancer

    Copacabana, Rio de Janeiro, CEP 22040-010

Other trials in Brazil

China1 site

  • Rui Jin Hospital

    Shanghai, 200025

Other trials in China

Colombia1 site

  • Hospital Militar Central

    Bogotá

Other trials in Colombia

Cyprus1 site

  • Bank Of Cyprus Oncology Centre

    Nicosia, 2006 Strovolos

Other trials in Cyprus

Germany1 site

  • Universitaetsklinikum Essen

    Essen, D-45122

Other trials in Germany

Japan1 site

  • Osaka National Hospital

    Osaka, 540-0006

Other trials in Japan

Lithuania1 site

  • Institute of Oncology at Vilnius University

    Vilnius, 08660

Other trials in Lithuania

North Macedonia1 site

  • Institute of Radiotherapy and Oncology

    Skopje, 1000

Other trials in North Macedonia

Portugal1 site

  • Hospital Santa Maria

    Lisbon, 1649-035

Other trials in Portugal

Romania1 site

  • Institutul Oncologic - Universitatea de Medicina

    Cluj-Napoca, 3400

Other trials in Romania

Serbia1 site

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000

Other trials in Serbia

South Africa1 site

  • Groote Schuur Hospital

    Cape Town, 7925

Other trials in South Africa

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

Turkey (Türkiye)1 site

  • Marmara University Hospital

    Istanbul, 81190

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain.

PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.

Read the detailed description

OBJECTIVES:

  • Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of the incidence of brain metastases and overall and disease free survival at 2 years in patients with limited stage small cell lung cancer in complete remission.
  • Evaluate the quality of life and late sequelae in this patient population treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and interval between the start of induction therapy and date of randomization (90 days or less vs 91-180 days vs more than 180 days). Patients are randomized into one of two treatment arms according to the prophylactic cranial radiotherapy dose.

  • Arm I: Patients receive standard-dose prophylactic cranial radiotherapy (10 fractions/12 days).
  • Arm II: Patients receive high-dose prophylactic cranial radiotherapy administered over 16 or 24 days based on the choice of their treatment center.
  • 18 fractions/24 days (conventional radiotherapy) OR
  • 24 fractions/16 days (accelerated hyperfractionated radiotherapy) Patients with isolated brain failure may undergo further radiotherapy.

Quality of life is assessed prior to randomization, at 6 months, at 1 year, and then annually thereafter.

Patients are followed at least every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study within 3 years.

Conditions
Lung Cancer
Being tested
radiation therapy
Keywords
limited stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of brain metastases 2 years after randomization

Secondary outcomes (3)

  1. Overall survival and disease-free survival 2 years after randomization

  2. Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter

  3. Treatment late sequelae as assessed by Late Effect of Normal Tissue - Subjective Objective Management Analytic scale, brain CT scan, or MRI before randomization and then annually thereafter

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 startSep 1999
  3. Primary completionDec 2005
  4. Study completionDec 2005

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005062
Sponsor's protocol ID
CDR0000067664
Other IDs
FRE-IGR-PCI-99, EU-99051, FRE-IFCT-99.01, FRE-IGR-PCI99-EULINT1, EORTC-22003, EORTC-08004
Status last verified
Mar 2014
First submitted
6 Apr 2000
Last updated
13 Mar 2014
Results posted
No

Publications

  • Le Pechoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20.

    PubMed 19386548

  • Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.

  • Le Pechoux C, Laplanche A, Faivre-Finn C, Ciuleanu T, Wanders R, Lerouge D, Keus R, Hatton M, Videtic GM, Senan S, Wolfson A, Jones R, Arriagada R, Quoix E, Dunant A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Clinical neurological outcome and quality of life among patients with limited small-cell cancer treated with two different doses of prophylactic cranial irradiation in the intergroup phase III trial (PCI99-01, EORTC 22003-08004, RTOG 0212 and IFCT 99-01). Ann Oncol. 2011 May;22(5):1154-1163. doi: 10.1093/annonc/mdq576. Epub 2010 Dec 7.

    PubMed 21139020

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing radiation therapy in people with Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 93 sites in 28 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 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in France, United Kingdom, Belgium, Greece, Netherlands and 23 more countries. 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.

What does the primary outcome measure?

Incidence of brain metastases 2 years after randomization. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005062, which also lists 3 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 13 Mar 2014.

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