Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)
Public ClinicalTrials.gov record NCT01555710. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of palifosfamide-tris, carboplatin and etoposide (PaCE) chemotherapy in chemotherapy-naive subjects with extensive-stage small cell lung cancer (SCLC). Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or carboplatin and etoposide (CE) chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response and changes in quality of life (QOL) and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.
Study identification
- NCT ID
- NCT01555710
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 188 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 8, 2012 (Actual)
- Primary completion
- Dec 2, 2014 (Actual)
- Completion
- Dec 2, 2014 (Actual)
- Last update posted
- Oct 1, 2026
2012 – 2014
United States locations
- U.S. sites
- 40
- U.S. states
- 24
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Hematology and Oncology Associates, LLC | Birmingham | Alabama | 35205 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Redwood Regional Oncology Group | Santa Rosa | California | 95403 | — |
| Christiana Care Health Services | Newark | Delaware | 19713 | — |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | — |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| Peachtree Hematology Oncology Consultants | Atlanta | Georgia | 30318 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Medical and Surgical Specialists, LLC | Galesburg | Illinois | 61401 | — |
| Illinois Cancer Specialists | Niles | Illinois | 60714-5905 | — |
| Central Indiana Cancer Centers | Fishers | Indiana | 46037 | — |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Horizon Oncology Center | Lafayette | Indiana | 47905 | — |
| Indiana University Health Ball Memorial Hospital | Muncie | Indiana | 47303 | — |
| University of Kansas Hospital | Overland Park | Kansas | 66210 | — |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | — |
| Medical Oncology, LLC | Baton Rouge | Louisiana | 70809 | — |
| Frederick Memorial Hospital Regional Cancer Therapy Center | Frederick | Maryland | 21701 | — |
| Metro Health Cancer Center | Wyoming | Michigan | 49519 | — |
| Saint Mary's Medical Center | Duluth | Minnesota | 55805 | — |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | — |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center | Morristown | New Jersey | 07962 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| New York Oncology Hematology, PC | Albany | New York | 12110-2188 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Dayton Cancer Center, Medical Oncology Hematology Associates | Dayton | Ohio | 45429 | — |
| Medical Oncology Associates Of Wyoming Valley, PC | Kingston | Pennsylvania | 18704 | — |
| Charleston Hematology Oncology Associates, PA | Charleston | South Carolina | 29403 | — |
| Texas Oncology-Medical City Dallas | Dallas | Texas | 75230-6899 | — |
| Texas Oncology- Baylor, Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555-0565 | — |
| Oncology Consultants, PA | Houston | Texas | 77024 | — |
| Texas Oncology, PA | Wichita Falls | Texas | 76310-1610 | — |
| Fletcher Allen Health Care | Burlington | Vermont | 05405 | — |
| Fairfax Northern Virginia Hematology-Oncology, PC | Fairfax | Virginia | 22031 | — |
| Swedish Medical Center | Seattle | Washington | 98104 | — |
| Wisconsin Institutes for Medical Research | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01555710, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01555710 live on ClinicalTrials.gov.