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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.
 
ClinicalTrials.gov Identifier: NCT00030771
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : May 22, 2019
Sponsor:
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.

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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
Actual Study Start Date : April 4, 2001
Actual Primary Completion Date : April 9, 2014
Estimated Study Completion Date : December 2037

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 (hematological, renal and neurological toxicities, nausea and vomiting, weight changes as well as esophageal toxicities) [ 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.



Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • 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

Pulmonary:

  • Lung function appropriate

Neurologic:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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)

Radiotherapy:

  • No prior radiotherapy to chest

Surgery:

  • Not specified

Other:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT00030771


Locations
Show Show 25 study locations
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00030771    
Other Study ID Numbers: SAKK 16/00
SWS-SAKK-16/00 ( Other Identifier: SAKK )
EU-20138
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
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:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases