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Non-Small Cell Lung CancerPhase 3NCT00216125

Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer

A Phase 3 study testing Cisplatin, Etoposide and Radiation in people with Non-Small Cell Lung Cancer, run by Nasser Hanna, M.D. at 15 sites in United States.

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

In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Cisplatin, Etoposide and Radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
15 sitesUnited States
Study dates
Feb 2002to Mar 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic or cytologic evidence of NSCLCUnresectable Stage IIIA (N2) OR Stage IIIB NSCLC.
  • Unresectable Stage IIIA will be defined by the following criteria:
  • N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan such that in the opinion of the treating investigator, the patient is not a candidate for surgical resection
  • N2 disease must be documented by biopsy, FDG-PET scan imaging, or by CT if nodes are > 2 cm on CT scan
  • Stage IIIb patients must have N3 or T4 status. N3 status must be documented by one of the following criteria:
  • Contralateral (to the primary tumor) mediastinal lymph node, supraclavicular or scalene lymph nodes proven by biopsy, FDG-PET scan imaging, or by CT if nodes are > 2 cm on CT scan.
Show all 15Show fewer
  • Patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region.
  • All patients must have measurable or evaluable disease documented by CT, MRI, X-ray or physical exam within 28 days prior to study treatment.
  • Negative pregnancy test
  • Eligibility for Consolidation Therapy
  • Following completion of induction chemoradiotherapy patients without local progression of disease or distant metastases will then be randomized to receive consolidation therapy with docetaxel or observation. Patients will be stratified and randomized based on stage IIIa vs IIIb disease at baseline, CR vs. non-CR following induction chemoradiation, and ECOG PS 0 or 1 vs. 2.
  • Patients must have completed chemoradiotherapy per protocol and at least 4 weeks but no more than 8 weeks must have elapsed from the last day of induction therapy (the last day of radiation) to be eligible for randomization to consolidation with docetaxel or observation.
  • Patients must have undergone re-staging tests according to the study calendar and determined to have no evidence of disease progression to be eligible for randomization to consolidation with docetaxel or observation.
  • Patients must have an ANC > 1,500/mm3, platelet count > 100,000/ mm3, and hemoglobin > 8 g/dl obtained within 14 days prior to registration for randomization to consolidation with docetaxel or observation.
  • Patients must have adequate hepatic function as defined by a serum bilirubin < institutional upper limit of normal (ULN) and an AST and/or ALT < 2.5 X the upper limits of normal if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 X ULN if transaminases are < ULN within 14 days prior to registration for randomization to consolidation with docetaxel or observation.

Who cannot join

  • No prior chemotherapy or radiotherapy for lung cancer.
  • No unintended weight loss > 5% body weight in the preceding 3 months prior to study treatment will not be eligible for this trial.
  • No symptomatic peripheral neuropathy prior to entry onto the study. Peripheral neuropathy must be < Grade 1 to be eligible.
  • No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.
  • No history of allergic reactions to drugs utilizing the vehicle polysorbate 80 (docetaxel) and polysorbate 80 + polyethylene glycol (etoposide).
  • If the patient has hearing loss at pre-study, performance of an audiogram is recommended (not mandatory) to document baseline hearing status in the event of possible further hearing loss due to cisplatin administration.
  • No current breastfeeding

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Elkhart Clinic

    Elkhart, Indiana, 46515

  • Oncology Hematology Associates of SW Indiana

    Evansville, Indiana, 47714

  • Fort Wayne Oncology & Hematology, Inc

    Fort Wayne, Indiana, 46815

  • Medical & Surgical Specialists, LLC

    Galesburg, Illinois, 61401

  • Center for Cancer Care at Goshen Health System

    Goshen, Indiana, 46527

  • US Oncology

    Houston, Texas, 77060

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • Quality Cancer Center (MCGOP)

    Indianapolis, Indiana, 46202

  • Community Regional Cancer Center

    Indianapolis, Indiana, 46256

  • Medical Consultants, P.C.

    Muncie, Indiana, 47303

  • Center for Cancer Care, Inc., P.C.

    New Albany, Indiana, 47150

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Siteman Cancer Center

    St Louis, Missouri, 63110

  • AP&S Clinic

    Terre Haute, Indiana, 47804

Other trials in United States

About this study

Official title: A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With or Without Consolidation Docetaxel in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN01-24

In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC.

This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease. The purpose of the trial is to evaluate survival and toxicities of the regimens employed.

Read the detailed description

OUTLINE: This is a multi-center study.

  • Cisplatin 50 mg/m2 d1, 8, 29, 36
  • Etoposide 50 mg/m2/day d1-5, 29-33
  • Radiation 5940 cGy (180 cGy/day)

Patients with CR, PR, SD Randomized to either:Docetaxel75 mg/m2 q3wk X 3 cycles

or Observation Only

Performance Status: ECOG 0 or 1

Life Expectancy: Not specified

Hematopoietic:

  • ANC > 1,500/mm3
  • Platelet count > 100,000/mm3
  • Hemoglobin > 8 g/dl. PRBC transfusions will be allowed to increase hemoglobin to >8 g/dl

Hepatic:

  • Serum bilirubin < institutional upper limit of normal (ULN)
  • AST < 2.5 X the upper limits of normal if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 X ULN if AST are < ULN

Renal:

  • Serum creatinine of < 2 mg/dl or calculated creatinine clearance > 50 cc/min

Cardiovascular:

  • No clinically significant history of cardiac disease, (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication).

Pulmonary:

  • Pre-registration FEV1 > 1 liters by spirometry within 42 days prior to study treatment.
Keywords
Non-Small Cell Lung Cancer
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.

  • CisplatinDrug

    Also called Platinol

    Cisplatin 50 mg/m2 day 1, 8, 29, 36

  • EtoposideDrug

    Also called VP-16

    Etoposide 50 mg/m2, days 1-5, 29-33

  • RadiationRadiation

    Radiation 5940 cGy (180 cGy/day)

  • DocetaxelDrug

    Also called Taxol

    docetaxel 75mg/m2 q3wk x 3 cycles

Study groups in NCT00216125
Study groupRoleWhat they receive
Pre-RandomizationOtherPrior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.
Receives: Drug: Cisplatin; Drug: Etoposide; Radiation: Radiation
Consolidation DocetaxelActive comparatorDocetaxel 75 mg/m^2 q3wk X 3 cycles.
Receives: Drug: Docetaxel
Observation OnlyNo interventionPatients were followed for Observation.

What is being measured

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

  1. Overall Survival

    A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.

    Measured: Participants were measured from treatment initiation to death

Secondary outcomes (1)

  1. Progression Free Survival

    A comparison of progression free survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median PFS time and a log rank test were used to analyze the hypothesized improvement in progression free survival.

    Progression is defined by RECIST as a 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.

    Measured: Participants were monitored from treatment initiation until disease progression per RECIST or death

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startFeb 2002
  3. Primary completionJun 2006
  4. Study completionMar 2008

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00216125
Sponsor's protocol ID
HOG LUN01-24
Status last verified
Feb 2016
First submitted
12 Sep 2005
Last updated
16 Mar 2016
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Hanna N, Neubauer M, Yiannoutsos C, McGarry R, Arseneau J, Ansari R, Reynolds C, Govindan R, Melnyk A, Fisher W, Richards D, Bruetman D, Anderson T, Chowhan N, Nattam S, Mantravadi P, Johnson C, Breen T, White A, Einhorn L; Hoosier Oncology Group; US Oncology. Phase III study of cisplatin, etoposide, and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer: the Hoosier Oncology Group and U.S. Oncology. J Clin Oncol. 2008 Dec 10;26(35):5755-60. doi: 10.1200/JCO.2008.17.7840. Epub 2008 Nov 10.

    PubMed 19001323

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Etoposide and Radiation in people with Non-Small Cell Lung Cancer, run by Nasser Hanna, M.D. at 15 sites in United States.

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 15 inclusion and 7 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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. 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?

Yes. Results are posted in the registry (first posted 8 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (time frame: Participants were measured from treatment initiation to death). 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 NCT00216125, which also lists 1 linked publication.

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 16 Mar 2016.

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