Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00002623|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
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|
- 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|
|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 Start Date :||December 1994|
|Actual Primary Completion Date :||December 2002|
Please refer to this study by its ClinicalTrials.gov 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|
|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|
|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|
|Helmond, Netherlands, 5707-HA|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 CA|
|Sint Antonius Ziekenhuis|
|Nieuwegein, Netherlands, 3435 CM|
|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|
|Utrecht, Netherlands, 3508 TG|
|Zwolle, Netherlands, 8000 GK|
|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|
|Study Chair:||Ted A.W. Splinter, MD||University Medical Center Rotterdam at Erasmus Medical Center|