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| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-16/00 | Other Identifier | SAKK | |
| EU-20138 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery |
|
| Arm B | Active Comparator | Neoadjuvant Chemotherapy + Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Docetaxel (Taxotere®) 85 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | 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. | 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative mortality assessed | All deaths occurring within 30 days of the thoracic surgery to remove the primary tumor | 1 month after surgery |
| Toxicity (hematological, renal and neurological toxicities, nausea and vomiting, weight changes as well as esophageal toxicities) |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Stage IIIA (T1-3, N2, M0)
N2 disease confirmed by 1 of the following:
Mediastinoscopy
Bronchoscopy with fine-needle aspiration or esophagoscopy
PET scan
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Miklos Pless, MD | Kantonsspital Winterthur KSW | Study Chair |
| Hans-Beat Ris, MD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Diana Naehrig, MD | Universitaetsspital-Basel | Principal Investigator |
| Roger Stupp, MD | Centre Hospitalier Universitaire Vaudoise | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Loewenstein gGmbH | Löwenstein | 74245 | Germany | |||
| Klinikum der Stadt Mannheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19086609 | Background | Tieu BH, Sanborn RE, Thomas CR Jr. Neoadjuvant therapy for resectable non-small cell lung cancer with mediastinal lymph node involvement. Thorac Surg Clin. 2008 Nov;18(4):403-15. doi: 10.1016/j.thorsurg.2008.07.004. | |
| 26275735 | Derived | Pless M, Stupp R, Ris HB, Stahel RA, Weder W, Thierstein S, Gerard MA, Xyrafas A, Fruh M, Cathomas R, Zippelius A, Roth A, Bijelovic M, Ochsenbein A, Meier UR, Mamot C, Rauch D, Gautschi O, Betticher DC, Mirimanoff RO, Peters S; SAKK Lung Cancer Project Group. Induction chemoradiation in stage IIIA/N2 non-small-cell lung cancer: a phase 3 randomised trial. Lancet. 2015 Sep 12;386(9998):1049-56. doi: 10.1016/S0140-6736(15)60294-X. Epub 2015 Aug 11. |
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| Radiotherapy | Radiation | Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks |
|
| Surgery | Procedure | 3-4 weeks after termination of radiotherapy |
|
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. |
| During treatment |
| Complete resection rate after surgery | Assessed according to the NCIC-CTG Expanded Common Toxicity Criteria grading. | 1 month after surgery |
| Objective response rate measured after completion of chemoradiotherapy | Response rate will be evaluated according to the
| 43 days |
| Operability | Patients who are able to undergo radical resection of their lung cancer after neoadjuvant therapy, as assessed by the thoracic surgeon. | 1 month after chemo |
| Overall survival | 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. | Life-long follow-up until death of patient (up to 30 years) |
| Failure pattern | 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. | Life-long follow-up until death of patient (up to 30 years) |
| Mannheim |
| D-68135 |
| Germany |
| Institut za plucne bolesti | Kamenitz | 21204 | Serbia |
| Institute of Oncology | Kamenitz | 21204 | Serbia |
| Kantonsspital Aarau | Aarau | CH-5001 | Switzerland |
| Kantonsspital Baden | Baden | CH-5404 | Switzerland |
| Kantonsspital | Baden | CH-5404 | Switzerland |
| Saint Claraspital AG | Basel | CH-4016 | Switzerland |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli | Bellinzona | 6500 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Kantonsspital Bruderholz | Bruderholz | CH-4101 | Switzerland |
| Kantonsspital Graubuenden | Chur | CH-7000 | Switzerland |
| Kantonsspital Freiburg | Fribourg | 1708 | Switzerland |
| Hopital Cantonal Universitaire de Geneve | Geneva | CH-1211 | Switzerland |
| Centre Pluridisciplinaire d' Oncologie | Lausanne | 1011 | Switzerland |
| Kantonsspital Liestal | Liestal | CH-4410 | Switzerland |
| Kantonsspital Olten | Olten | CH-4600 | Switzerland |
| FMH Onkologie/Haematologie | Rheinfelden | 4310 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Regionalspital | Thun | 3600 | Switzerland |
| Kantonsspital Winterthur | Winterthur | CH-8400 | Switzerland |
| Onkozentrum | Zurich | 8038 | Switzerland |
| City Hospital Triemli | Zurich | CH-8063 | Switzerland |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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