Study Stopped
low accrual
Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC
A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)
4 other identifiers
interventional
13
1 country
1
Brief Summary
The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lung-cancer
Started Mar 2003
Longer than P75 for phase_2 lung-cancer
1 active site
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
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 11, 2005
CompletedFirst Posted
Study publicly available on registry
October 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedResults Posted
Study results publicly available
July 4, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMay 12, 2015
April 1, 2015
6.5 years
October 11, 2005
September 24, 2012
April 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.
Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.
Two years
Secondary Outcomes (1)
Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival
baseline, 5 weeks after combined chemo-radiation
Other Outcomes (1)
Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen
Specimen collected at time of surgery
Study Arms (1)
Chemotherapy+Radiation+Surgery
EXPERIMENTAL1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy. 2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy. 3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation 4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
Interventions
NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.
All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.
Eligibility Criteria
You may qualify if:
- Histologically confirmed stage IIIA or IIIB NSCLC
- Patients must have measurable disease
- No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.
- Age\>18 years
- Life expectancy \>12 months
- ECOG performance status 0-1
- Normal organ and marrow function
- Medically fit for surgery at time of enrollment.
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment.
- Ability to understand and willingness to sign the consent form.
You may not qualify if:
- Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC.
- Patients receiving any other investigational agents.
- Known metastatic disease (brain or any other site)
- History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
- Peripheral neuropathy \>grade 1
- Uncontrolled concurrent illness
- Pregnant women
- Weight loss\>10% in the past 3 months before diagnosis.
- HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Aventis Pharmaceuticalscollaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (2)
Kozak MM, Murphy JD, Schipper ML, Donington JS, Zhou L, Whyte RI, Shrager JB, Hoang CD, Bazan J, Maxim PG, Graves EE, Diehn M, Hara WY, Quon A, Le QT, Wakelee HA, Loo BW Jr. Tumor volume as a potential imaging-based risk-stratification factor in trimodality therapy for locally advanced non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):920-6. doi: 10.1097/jto.0b013e31821517db.
PMID: 21774104RESULTDas M, Donington JS, Murphy J, Kozak M, Eclov N, Whyte RI, Hoang CD, Zhou L, Le QT, Loo BW, Wakelee H. Results from a single institution phase II trial of concurrent docetaxel/carboplatin/radiotherapy followed by surgical resection and consolidation docetaxel/carboplatin in stage III non-small-cell lung cancer. Clin Lung Cancer. 2011 Sep;12(5):280-5. doi: 10.1016/j.cllc.2011.06.003. Epub 2011 Jul 14.
PMID: 21752720RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Accrual was very slow. The study was halted with accrual of only 13 patients. These results were published.
Results Point of Contact
- Title
- Dr. Heather Wakelee
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Heather A. Wakelee
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
October 11, 2005
First Posted
October 13, 2005
Study Start
March 1, 2003
Primary Completion
September 1, 2009
Study Completion
November 1, 2014
Last Updated
May 12, 2015
Results First Posted
July 4, 2013
Record last verified: 2015-04