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Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer Clinical research trials and Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer  Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
For Condition: squamous cell lung cancer,large cell lung cancer,stage 3A non-small cell lung cancer,adenocarcinoma of the lung,adenosquamous cell lung cancer,bronchoalveolar cell lung cancer
Status: No longer recruiting
Sponsor(s): EORTC Lung Cancer Cooperative Group ,
Synopsis: 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.
Details: 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. - 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. - 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TedSplinter, Study Chair, University Hospital - Rotterdam Dijkzigt
Academisch Ziekenhuis Utrecht
Vandoeuvre-les-Nancy, , 54511
France
Arnhems Radiotherapeutisch Instituut
ARNHEM, , 6815 AD
Netherlands
Stedelijk Ziekenhuis
Roesclare, , 8800
Belgium
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , 16132
Italy
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, , 5211 NL
Netherlands
Twee Steden Ziekenhuis Vestiging Tilburg
Tilburg, , 5042 AD
Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, , 3435 CM
Netherlands
A.Z. St. Jan
Brugge, , 8000
Belgium
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
CHR - Clinique Saint Joseph - Hopital de Warqueguies
Mons, , B-7000
Belgium
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Ziekenhuis St Jansdal
Harderwijk, , 3840 AC
Netherlands
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Royal Victoria Hospital
Belfast, Northern Ireland, BT12 6BA
United Kingdom
Sophia Ziekehuis
Zwolle, , 8000 GK
Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Atrium Medical Centre
HEERLEN, , 6419 PC
Netherlands
Elkerliek Ziekenhuis
Helmond, , 5707-HA
Netherlands
Saint Franciscus Ziekenhuis
Roosendaal, , 4708 AE
Netherlands
Diakonessenhuis Utrecht
Utrecht, , 3508 TG
Netherlands
Leicester Royal Infirmary
Leicester, England, LE1 5WW
United Kingdom
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , 6532 SZ
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , 1001HV
Netherlands
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Erasmus Medical Center
Rotterdam, , 3075 EA
Netherlands
University Hospital - Rotterdam Dijkzigt
Rotterdam, , 3000 CA
Netherlands
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, , 5530
Belgium
Hopital de Jolimont
Haine-Saint-Paul, , 7100
Belgium
Additional Information:
Study ID Numbers: CDR0000063983; EORTC-08941
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002623
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
2. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
3. Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
4. Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
5. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Clinical Trials
Other Roosendaal Clinical Trials
Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
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