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Lung CancerPhase 3NCT00030771

Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients

A Phase 3 study testing Chemotherapy, Radiotherapy and Surgery in people with Lung Cancer, run by Swiss Cancer Institute at 25 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Cancer
What is being tested?
Chemotherapy, Radiotherapy and Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
25 sitesin 3 countries
Study dates
4 Apr 2001to 15 Sep 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

Switzerland21 sites

  • Kantonsspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, CH-5404

  • Kantonsspital

    Baden, CH-5404

  • Saint Claraspital AG

    Basel, CH-4016

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

    Bellinzona, 6500

  • Inselspital Bern

    Bern, CH-3010

  • Kantonsspital Bruderholz

    Bruderholz, CH-4101

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Kantonsspital Freiburg

    Fribourg, 1708

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Pluridisciplinaire d' Oncologie

    Lausanne, 1011

  • Kantonsspital Liestal

    Liestal, CH-4410

  • Kantonsspital Olten

    Olten, CH-4600

  • FMH Onkologie/Haematologie

    Rheinfelden, 4310

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Regionalspital

    Thun, 3600

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • Onkozentrum

    Zurich, 8038

  • City Hospital Triemli

    Zurich, CH-8063

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

Germany2 sites

  • Klinik Loewenstein gGmbH

    Löwenstein, 74245

  • Klinikum der Stadt Mannheim

    Mannheim, D-68135

Other trials in Germany

Serbia2 sites

  • Institut za plucne bolesti

    Kamenitz, 21204

  • Institute of Oncology

    Kamenitz, 21204

Other trials in Serbia

About this study

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

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.

Read the 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.

Conditions
Lung Cancer
Being tested
Chemotherapy, Radiotherapy, Surgery
Keywords
squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, adenosquamous cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

    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

  • RadiotherapyRadiation

    Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks

  • SurgeryProcedure or surgery

    3-4 weeks after termination of radiotherapy

Study groups in NCT00030771
Study groupRoleWhat they receive
Arm AActive comparatorNeoadjuvant Chemoradiotherapy + Chemotherapy + Surgery
Receives: Drug: Chemotherapy; Radiation: Radiotherapy; Procedure: Surgery
Arm BActive comparatorNeoadjuvant Chemotherapy + Surgery
Receives: Drug: Chemotherapy; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month after surgery

Secondary outcomes (7)

  1. Postoperative mortality assessed

    All deaths occurring within 30 days of the thoracic surgery to remove the primary tumor

    Measured: 1 month after surgery

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

    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.

    Measured: During treatment

  3. Complete resection rate after surgery

    Assessed according to the NCIC-CTG Expanded Common Toxicity Criteria grading.

    Measured: 1 month after surgery

  4. Objective response rate measured after completion of chemoradiotherapy

    Response rate will be evaluated according to the

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

    Measured: 43 days

  5. Operability

    Patients who are able to undergo radical resection of their lung cancer after neoadjuvant therapy, as assessed by the thoracic surgeon.

    Measured: 1 month after chemo

  6. 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.

    Measured: Life-long follow-up until death of patient (up to 30 years)

  7. 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.

    Measured: Life-long follow-up until death of patient (up to 30 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start4 Apr 2001
  3. Primary completion9 Apr 2014
  4. Study completion15 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030771
Sponsor's protocol ID
SAKK 16/00
Other IDs
SWS-SAKK-16/00, EU-20138
Status last verified
Jan 2024
First submitted
14 Feb 2002
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 19086609

  • 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.

    PubMed 26275735

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chemotherapy, Radiotherapy and Surgery in people with Lung Cancer, run by Swiss Cancer Institute at 25 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Switzerland, Germany, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00030771, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.

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