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Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030771
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : May 15, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Chemotherapy Radiation: Radiotherapy Procedure: Surgery Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2001
Primary Completion Date : October 2013
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm A
Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery
Drug: Chemotherapy
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
Radiation: Radiotherapy
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
Procedure: Surgery
3-4 weeks after termination of radiotherapy
Active Comparator: Arm B
Neoadjuvant Chemotherapy + Surgery
Drug: Chemotherapy
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
Procedure: Surgery
3-4 weeks after termination of radiotherapy

Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 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 :
  1. Postoperative mortality assessed [ Time Frame: 1 month after surgery ]
    All deaths occurring within 30 days of the thoracic surgery to remove the primary tumor

  2. Toxicity [ Time Frame: 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.

  3. Complete resection rate after surgery [ Time Frame: 1 month after surgery ]
    Assessed according to the NCIC-CTG Expanded Common Toxicity Criteria grading.

  4. Objective response rate measured after completion of chemoradiotherapy [ Time Frame: 43 days ]

    Response rate will be evaluated according to the

    1. WHO response criteria
    2. TNM classification after surgery.

  5. Operability [ Time Frame: 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.

  6. Overall survival [ Time Frame: 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.

  7. Failure pattern [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer

    • Squamous, adenosquamous, large cell, or poorly differentiated
  • Stage IIIA (T1-3, N2, M0)

    • N2 disease confirmed by 1 of the following:

      • Mediastinoscopy
      • Bronchoscopy with fine-needle aspiration or esophagoscopy

        • All N3 lymph nodes must be negative by positron-emission tomography (PET) AND CT scan (< 1 cm in the largest diameter)
      • PET scan

        • Both the primary tumor and at least 1 N2 lymph node must be positive in PET scan
        • At least 1 of the PET scan positive N2 lymph nodes is positive in the CT scan (> 1 cm in the largest diameter)
        • All N3 lymph nodes negative in PET scan



  • 18 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • AST/ALT no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine clearance greater than 60 mL/min


  • Cardiac function normal
  • No unstable cardiac disease requiring treatment
  • No congestive heart failure
  • No angina pectoris even if medically controlled
  • No significant arrhythmia
  • No myocardial infarction in the past 3 months


  • Lung function appropriate


  • No history of significant neurologic or psychiatric disorders
  • No psychotic disorders
  • No dementia
  • No seizures


  • No other prior or concurrent malignancies except nonmelanoma skin cancer, adequately treated carcinoma in situ of the cervix, or any other neoplastic disease with a disease-free interval ≥ 5 years
  • No active uncontrolled infection
  • No uncontrolled diabetes mellitus
  • No gastric ulcers
  • No pre-existing peripheral neuropathy greater than grade 1
  • No contraindications to corticosteroids
  • No other serious underlying medical condition that would preclude study participation
  • No socioeconomic or geographic condition that would preclude study participation
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • No prior cytostatic chemotherapy

Endocrine therapy:

  • No concurrent prednisone except for treatment of acute hypersensitivity reactions or chronic low-dose treatment initiated more than 6 months prior to study entry (i.e., no greater than 20 mg methylprednisolone or equivalent)


  • No prior radiotherapy to chest


  • Not specified


  • At least 30 days since participation in another clinical study
  • No other concurrent experimental drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030771

Klinik Loewenstein gGmbH
Löwenstein, Germany, 74245
Klinikum der Stadt Mannheim
Mannheim, Germany, D-68135
Institut za plucne bolesti
Sremska Kamenica, Serbia, 21204
Institute of Oncology
Sremska Kamenica, Serbia, 21204
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Kantonsspital Baden
Baden, Switzerland, CH-5404
Baden, Switzerland, CH-5404
Saint Claraspital AG
Basel, Switzerland, CH-4016
Basel, Switzerland, CH-4031
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, Switzerland, 6500
Inselspital Bern
Bern, Switzerland, CH-3010
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Kantonsspital Freiburg
Freiburg, Switzerland, 1708
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Pluridisciplinaire d' Oncologie
Lausanne, Switzerland, 1011
Kantonsspital Liestal
Liestal, Switzerland, CH-4410
Kantonsspital Olten
Olten, Switzerland, CH-4600
FMH Onkologie/Haematologie
Rheinfelden, Switzerland, 4310
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Thun, Switzerland, 3600
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
Zurich, Switzerland, 8038
City Hospital Triemli
Zurich, Switzerland, CH-8063
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Miklos Pless, MD Kantonsspital Winterthur KSW
Principal Investigator: Hans-Beat Ris, MD Centre Hospitalier Universitaire Vaudois
Principal Investigator: Diana Naehrig, MD Universitaetsspital-Basel
Principal Investigator: Roger Stupp, MD Centre Hospitalier Universitaire Vaudoise

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00030771     History of Changes
Other Study ID Numbers: SAKK 16/00
SWS-SAKK-16/00 ( Other Identifier: SAKK )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Swiss Group for Clinical Cancer Research:
squamous cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
adenosquamous cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases