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AzTrials

Non-Small Cell Lung CancerPhase 3NCT00176137

Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 study testing preoperative radiochemotherapy in people with Non-Small Cell Lung Cancer, run by Heidelberg University.

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

Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide, followed by surgery and then RT. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
preoperative radiochemotherapy
Type of treatment
Surgery or procedure
How many people
500 participants
Where
No sites listed yet
Study dates
Oct 1995to Sep 2005
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • non-small cell lung cancer proven by histology
  • stage IIIA / stage IIIB
  • mediastinoscopy
  • performance score ECOG 0,1
  • predicted postoperative FEV 1 > 1.0 l

Who cannot join

  • small cell lung cancer
  • cardiac disability (NYHA III/IV)
  • prior radio- or chemotherapy
  • pregnancy
  • other malignancy

About this study

Official title: Cisplatin/Etoposide Followed by Twice-Daily Chemoradiation (hfRT/CT) Versus Cisplatin/Etoposide Alone Before Surgery in Stage III Non-Small Cell Lung Cancer. A Phase III Trial of the German Lung Cancer Cooperative Group (GLCCG)

Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide, followed by surgery and then RT.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

Read the detailed description

Patients are randomized to (arm A) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4), followed by hyperfractionated radiotherapy (hfRT; 45 Gy, 2x1.5 Gy/d) with concurrent carboplatin (100 mg/m2) and vindesine (3 mg) (d 1, 8, 15), then surgery and, if no or R1/2-resection, additional hfRT (24 Gy; 2x1.5 Gy/d) versus (arm B) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4),followed by surgery and then RT (1.8 Gy/d) with 54 Gy or, if no or R1/2-resection, 68.4 Gy.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

(University of Münster was the lead sponsor; as the trial was implemented in clinicaltrials.gov by the principal investigator after he had moved to University of Heidelberg this account is announced above)

Being tested
preoperative radiochemotherapy
Keywords
multimodality treatment
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • preoperative radiochemotherapyProcedure or surgery

What is being measured

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

  1. Progression free survival

Secondary outcomes (1)

  1. Overall survival

Timeline

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

  1. First posted15 Sep 2005 (estimated)
  2. Study startOct 1995
  3. Study completionSep 2005

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
Parallel groups
Masking
None (open label)
Enrolment
500 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00176137
Sponsor's protocol ID
GLCCG01/95
Other IDs
German Cancer Aid
Status last verified
Apr 2008
First submitted
13 Sep 2005
Last updated
22 Apr 2008
Results posted
No

Publications

  • Kreuter M, Kropff M, Fischaleck A, Junker K, Gerss J, Heinecke A, Lindermann M, Reinmuth N, Berdel WE, Mesters RM, Thomas M. Prognostic relevance of angiogenesis in stage III NSCLC receiving multimodality treatment. Eur Respir J. 2009 Jun;33(6):1383-8. doi: 10.1183/09031936.00121108. Epub 2009 Feb 12.

    PubMed 19213790

  • Thomas M, Rube C, Hoffknecht P, Macha HN, Freitag L, Linder A, Willich N, Hamm M, Sybrecht GW, Ukena D, Deppermann KM, Droge C, Riesenbeck D, Heinecke A, Sauerland C, Junker K, Berdel WE, Semik M; German Lung Cancer Cooperative Group. Effect of preoperative chemoradiation in addition to preoperative chemotherapy: a randomised trial in stage III non-small-cell lung cancer. Lancet Oncol. 2008 Jul;9(7):636-48. doi: 10.1016/S1470-2045(08)70156-6. Epub 2008 Jun 24.

    PubMed 18583190

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing preoperative radiochemotherapy in people with Non-Small Cell Lung Cancer, run by Heidelberg University.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. 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 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

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?

Progression free survival. 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 NCT00176137, 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 22 Apr 2008.

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