Spots Global Cancer Trial Database for Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients
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Trial Identification
Brief Title: Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients
Official Title: Preoperative Chemoradiotherapy vs. Chemotherapy Alone in Non-small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase III Trial
Study ID: NCT00030771
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known if chemotherapy plus radiation therapy is more effective than chemotherapy alone before surgery in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying docetaxel and cisplatin with or without radiation therapy to see how well they work when given before surgery in treating patients with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest.
Detailed Description: The main objective of this trial is to compare feasibility and efficacy of sequential neoadjuvant chemoradiotherapy with 44 Gy concomitant boost to neoadjuvant chemotherapy alone. Secondary objectives are to assess the value of PET in predicting pathological response and eventfree survival in stage IIIA NSCLC, and a health economic analysis of the two regimens. Further to compare the amount of serum DNA in patients with stage IIIA, pN2 NSCLC before chemotherapy, before surgery and at the second follow-up visit (i.e. four months after surgery or treatment failure for patients who can not be operated) in patients randomized into the trial SAKK 16/00 and to correlate the DNA variation with tumor response, remission duration and overall survival. OUTLINE: This is a prospective randomized phase III trial. Patients are stratified according to mediastinal bulk (5 cm or more vs less than 5 cm), weight loss in the past 6 months (5% or more vs less than 5%), and participating center. Patients are randomized to 1 of 2 treatment arms.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinik Loewenstein gGmbH, Löwenstein, , Germany
Klinikum der Stadt Mannheim, Mannheim, , Germany
Institut za plucne bolesti, Sremska Kamenica, , Serbia
Institute of Oncology, Sremska Kamenica, , Serbia
Kantonsspital Aarau, Aarau, , Switzerland
Kantonsspital Baden, Baden, , Switzerland
Kantonsspital, Baden, , Switzerland
Saint Claraspital AG, Basel, , Switzerland
Universitaetsspital-Basel, Basel, , Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli, Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Kantonsspital Bruderholz, Bruderholz, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
Kantonsspital Freiburg, Freiburg, , Switzerland
Hopital Cantonal Universitaire de Geneve, Geneva, , Switzerland
Centre Pluridisciplinaire d' Oncologie, Lausanne, , Switzerland
Kantonsspital Liestal, Liestal, , Switzerland
Kantonsspital Olten, Olten, , Switzerland
FMH Onkologie/Haematologie, Rheinfelden, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Regionalspital, Thun, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Onkozentrum, Zurich, , Switzerland
City Hospital Triemli, Zurich, , Switzerland
UniversitaetsSpital Zuerich, Zurich, , Switzerland
Contact Details
Name: Miklos Pless, MD
Affiliation: Kantonsspital Winterthur KSW
Role: STUDY_CHAIR
Name: Hans-Beat Ris, MD
Affiliation: Centre Hospitalier Universitaire Vaudois
Role: PRINCIPAL_INVESTIGATOR
Name: Diana Naehrig, MD
Affiliation: Universitaetsspital-Basel
Role: PRINCIPAL_INVESTIGATOR
Name: Roger Stupp, MD
Affiliation: Centre Hospitalier Universitaire Vaudoise
Role: PRINCIPAL_INVESTIGATOR
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