AzTrials
AzTrials

Lung CancerPhase 2NCT00030810

Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC

A Phase 2 study testing Hyperfractionated, Taxotere/Cisplatin and conventional surgery in people with Lung Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.

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 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. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery. 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?
Hyperfractionated, Taxotere/Cisplatin and conventional surgery
Type of treatment
Surgery or procedure
How many people
46 participants
Where
1 siteSwitzerland
Study dates
Sep 2001to May 2006
Phase
Phase 2
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 confirmed, operable stage IIIB non-small cell lung cancer
  • T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for assessment of N3 disease) or CT scan or MRI of the thorax
  • Squamous cell
  • Adenosquamous cell
  • Large cell
  • Poorly differentiated
  • No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan, and abdominal ultrasound or CT scan
  • No malignant pleural or pericardial effusion
  • No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes

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

Renal:

  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No unstable cardiac disease requiring treatment
  • No congestive heart failure
  • No angina pectoris (even if medically controlled)
  • No significant arrhythmia
  • No myocardial infarction within the past 3 months

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No definite contraindications for the use of corticosteroids as premedication
  • No preexisting grade 2 or greater peripheral neuropathy
  • No active uncontrolled infection
  • No uncontrolled diabetes mellitus
  • No other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix
  • No prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent
  • No other serious underlying medical condition that would preclude study participation
  • No socioeconomic or geographical circumstances that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent)

Radiotherapy:

  • No prior radiotherapy to the chest

Surgery:

  • See Disease Characteristics

Other:

  • At least 30 days since prior treatment in a clinical trial
  • No prior cytostatic therapy
  • No other concurrent experimental drugs

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

About this study

Official title: Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial

RATIONALE: Drugs used in chemotherapy 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. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer.
  • Determine the rate of event-free survival at 1 year in patients treated with this regimen.
  • Determine the operability and complete resection rate in patients treated with this regimen.
  • Determine the postoperative 30-day mortality in patients treated with this regimen.
  • Determine the response rate, failure pattern, and overall survival in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.

Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.

Patients undergo surgery within 3-4 weeks after completion of radiotherapy.

Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.

Conditions
Lung Cancer
Being tested
Hyperfractionated, Taxotere/Cisplatin, conventional surgery
Keywords
squamous cell lung cancer, large cell lung cancer, stage IIIB 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.

  • HyperfractionatedRadiation

    Hyperfractionated radiotherapy

  • Taxotere/CisplatinDrug

    Taxotere/Cisplatin

  • conventional surgeryProcedure or surgery

    conventional surgery

What is being measured

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

  1. Rate of event-free survival measured 1 year after registration

Secondary outcomes (5)

  1. Operability after chemotherapy

  2. Postoperative mortality 30 days after surgery

  3. Complete resection rate after surgery

  4. Toxicity

  5. Response rate

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 startSep 2001
  3. Primary completionMay 2006
  4. Study completionMay 2006

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030810
Sponsor's protocol ID
SAKK 16/01
Other IDs
EU-20137
Status last verified
May 2019
First submitted
14 Feb 2002
Last updated
15 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Stupp R, Mayer M, Kann R, Weder W, Zouhair A, Betticher DC, Roth AD, Stahel RA, Majno SB, Peters S, Jost L, Furrer M, Thierstein S, Schmid RA, Hsu-Schmitz SF, Mirimanoff RO, Ris HB, Pless M. Neoadjuvant chemotherapy and radiotherapy followed by surgery in selected patients with stage IIIB non-small-cell lung cancer: a multicentre phase II trial. Lancet Oncol. 2009 Aug;10(8):785-93. doi: 10.1016/S1470-2045(09)70172-X. Epub 2009 Jul 13.

    PubMed 19604722

  • Pless M, Stupp R, Kann R, et al.: Preoperative chemoradiotherapy in non-small cell lung cancer (NSCLC) patients with operable stage IIIB disease: a phase II trial of the Swiss Group for Clinical Cancer Research (SAKK). [Abstract] J Clin Oncol 25 (Suppl 18): A-18021, 685s, 2007.

  • Fruh M, Betticher DC, Stupp R, Xyrafas A, Peters S, Ris HB, Mirimanoff RO, Ochsenbein AF, Schmid R, Matzinger O, Stahel RA, Weder W, Guckenberger M, Rothschild SI, Lardinois D, Mach N, Mark M, Gautschi O, Thierstein S, Biaggi Rudolf C, Pless M; Swiss Group for Clinical Cancer Research (SAKK). Multimodal Treatment in Operable Stage III NSCLC: A Pooled Analysis on Long-Term Results of Three SAKK trials (SAKK 16/96, 16/00, and 16/01). J Thorac Oncol. 2019 Jan;14(1):115-123. doi: 10.1016/j.jtho.2018.09.011. Epub 2018 Sep 26.

    PubMed 30267838

  • Fruh M, Ris HB, Xyrafas A, Peters S, Mirimanoff RO, Gautschi O, Pless M, Stupp R. Preoperative chemoradiotherapy with cisplatin and docetaxel for stage IIIB non-small-cell lung cancer: 10-year follow-up of the SAKK 16/01 trial. Ann Oncol. 2016 Oct;27(10):1971-3. doi: 10.1093/annonc/mdw251. Epub 2016 Jun 29. No abstract available.

    PubMed 27358380

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hyperfractionated, Taxotere/Cisplatin and conventional surgery in people with Lung Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.

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 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Rate of event-free survival measured 1 year after registration. 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 NCT00030810, which also lists 4 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 15 May 2019.

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