Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients
- Conditions
- Lung Cancer
- Interventions
- Drug: ChemotherapyRadiation: RadiotherapyProcedure: Surgery
- Registration Number
- NCT00030771
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm A Radiotherapy Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery Arm B Surgery Neoadjuvant Chemotherapy + Surgery Arm A Surgery Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery Arm A Chemotherapy Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery Arm B Chemotherapy Neoadjuvant Chemotherapy + Surgery
- Primary Outcome Measures
Name Time Method Event-free survival 1 month after surgery Time from randomization to relapse/progression/second tumor/death, whichever occurs first (for all randomized patients). If no event is observed, the patients will be censored at the last time they were known to be alive.
- Secondary Outcome Measures
Name Time Method Postoperative mortality assessed 1 month after surgery All deaths occurring within 30 days of the thoracic surgery to remove the primary tumor
Failure pattern Life-long follow-up until death of patient (up to 30 years) Defined as location of first tumor progression or relapse. Failure can be local relapse (area of primary tumor or mediastinum), distant relapse (all others) or the combination thereof.
Toxicity (hematological, renal and neurological toxicities, nausea and vomiting, weight changes as well as esophageal toxicities) During treatment Assessed according to the NCIC-CTG Expanded Common Toxicity Criteria grading. Special attention shall be given to hematological, renal and neurological toxicities, nausea and vomiting, weight changes as well as esophageal toxicities.
Objective response rate measured after completion of chemoradiotherapy 43 days Response rate will be evaluated according to the
1. WHO response criteria
2. TNM classification after surgery.Operability 1 month after chemo Patients who are able to undergo radical resection of their lung cancer after neoadjuvant therapy, as assessed by the thoracic surgeon.
Overall survival Life-long follow-up until death of patient (up to 30 years) Calculated from randomization to the date of death from any cause. Patients not experiencing an event will be censored at the last time they were known to be alive.
Complete resection rate after surgery 1 month after surgery Assessed according to the NCIC-CTG Expanded Common Toxicity Criteria grading.
Trial Locations
- Locations (25)
Klinikum der Stadt Mannheim
🇩🇪Mannheim, Germany
Kantonsspital Baden
🇨🇭Baden, Switzerland
Klinik Loewenstein gGmbH
🇩🇪Löwenstein, Germany
Institute of Oncology
🇷🇸Sremska Kamenica, Serbia
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Universitaetsspital-Basel
🇨🇭Basel, Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
🇨🇭Bellinzona, Switzerland
Kantonsspital Freiburg
🇨🇭Freiburg, Switzerland
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
FMH Onkologie/Haematologie
🇨🇭Rheinfelden, Switzerland
Regionalspital
🇨🇭Thun, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
Onkozentrum
🇨🇭Zurich, Switzerland
City Hospital Triemli
🇨🇭Zurich, Switzerland
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland
Kantonsspital
🇨🇭Baden, Switzerland
Centre Pluridisciplinaire d' Oncologie
🇨🇭Lausanne, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
Kantonsspital Olten
🇨🇭Olten, Switzerland
Institut za plucne bolesti
🇷🇸Sremska Kamenica, Serbia
Hopital Cantonal Universitaire de Geneve
🇨🇭Geneva, Switzerland
Kantonsspital Bruderholz
🇨🇭Bruderholz, Switzerland
Saint Claraspital AG
🇨🇭Basel, Switzerland
Kantonsspital Liestal
🇨🇭Liestal, Switzerland
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland