Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer
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
1 other identifier
interventional
243
1 country
15
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Feb 2002
Typical duration for phase_3 nonsmall-cell-lung-cancer
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
February 8, 2016
CompletedMarch 16, 2016
February 1, 2016
4.3 years
September 12, 2005
November 23, 2015
February 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Participants were measured from treatment initiation to death
Secondary Outcomes (1)
Progression Free Survival
Participants were monitored from treatment initiation until disease progression per RECIST or death
Study Arms (3)
Pre-Randomization
OTHERPrior 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.
Consolidation Docetaxel
ACTIVE COMPARATORDocetaxel 75 mg/m\^2 q3wk X 3 cycles.
Observation Only
NO INTERVENTIONPatients were followed for Observation.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nasser Hanna, M.D.lead
- Sanoficollaborator
- Walther Cancer Institutecollaborator
Study Sites (15)
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401, United States
Elkhart Clinic
Elkhart, Indiana, 46515, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202, United States
Community Regional Cancer Center
Indianapolis, Indiana, 46256, United States
Medical Consultants, P.C.
Muncie, Indiana, 47303, United States
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, 47150, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
AP&S Clinic
Terre Haute, Indiana, 47804, United States
Siteman Cancer Center
St Louis, Missouri, 63110, United States
Methodist Cancer Center
Omaha, Nebraska, 68114, United States
US Oncology
Houston, Texas, 77060, United States
Related Publications (1)
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.
PMID: 19001323RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Georgia Gould
- Organization
- Hoosier Cancer Research Network
Study Officials
- STUDY CHAIR
Nasser Hanna, M.D.
Hoosier Oncology Group, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 22, 2005
Study Start
February 1, 2002
Primary Completion
June 1, 2006
Study Completion
March 1, 2008
Last Updated
March 16, 2016
Results First Posted
February 8, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share