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Spots Global Cancer Trial Database for Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

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Trial Identification

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

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

Study ID: NCT00002623

Conditions

Lung Cancer

Study Description

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.

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Algemeen Ziekenhuis Middelheim, Antwerp, , Belgium

A.Z. St. Jan, Brugge, , Belgium

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

Hopital de Jolimont, Haine Saint Paul, , Belgium

U.Z. Gasthuisberg, Leuven, , Belgium

CHR - Clinique Saint Joseph - Hopital de Warqueguies, Mons, , Belgium

Clinique Universitaire De Mont-Godinne, Mont-Godinne Yvoir, , Belgium

Stedelijk Ziekenhuis, Roesclare, , Belgium

Academisch Ziekenhuis Utrecht, Vandoeuvre-les-Nancy, , France

Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova), , Italy

Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch, , Netherlands

Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands

Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands

Arnhems Radiotherapeutisch Instituut, Arnhem, , Netherlands

Ziekenhuis St Jansdal, Harderwijk, , Netherlands

Atrium Medical Centre, Heerlen, , Netherlands

Elkerliek Ziekenhuis, Helmond, , Netherlands

Leiden University Medical Center, Leiden, , Netherlands

Sint Antonius Ziekenhuis, Nieuwegein, , Netherlands

Canisius-Wilhelmina Ziekenhuis, Nijmegen, , Netherlands

University Medical Center Nijmegen, Nijmegen, , Netherlands

Saint Franciscus Ziekenhuis, Roosendaal, , Netherlands

University Hospital - Rotterdam Dijkzigt, Rotterdam, , Netherlands

Erasmus Medical Center, Rotterdam, , Netherlands

Twee Steden Ziekenhuis Vestiging Tilburg, Tilburg, , Netherlands

Diakonessenhuis Utrecht, Utrecht, , Netherlands

Sophia Ziekehuis, Zwolle, , Netherlands

Leicester Royal Infirmary, Leicester, England, United Kingdom

Royal Marsden Hospital, Sutton, England, United Kingdom

Royal Victoria Hospital, Belfast, Northern Ireland, United Kingdom

Contact Details

Name: Ted A.W. Splinter, MD

Affiliation: University Medical Center Rotterdam at Erasmus Medical Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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