A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy (AIO-STO-0111)
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ClinicalTrials.gov Identifier: NCT01248403 |
Recruitment Status :
Completed
First Posted : November 25, 2010
Last Update Posted : January 29, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | November 23, 2010 | ||||
First Posted Date ICMJE | November 25, 2010 | ||||
Last Update Posted Date | January 29, 2020 | ||||
Actual Study Start Date ICMJE | October 2011 | ||||
Actual Primary Completion Date | July 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
overall survival [ Time Frame: 6 months follow-up ] | ||||
Original Primary Outcome Measures ICMJE |
progression-free survival [ Time Frame: staging every 8 weeks ] | ||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy | ||||
Official Title ICMJE | A Randomized, Double-blind, Multi-center Phase III Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma Who Have Progressed After Therapy With a Fluoropyrimidine-containing Regimen | ||||
Brief Summary | Adult patients with gastric carcinoma which has progressed after initial treatment with a fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus placebo. The hypothesis is that patients with RAD001 have significantly prolonged overall survival compared to patients who are treated with paclitaxel alone. | ||||
Detailed Description | This is a randomized, double-blind, phase III two-arm multi-center study aiming at estimating the relative efficacy of the combination of RAD001 and paclitaxel versus that of paclitaxel alone as second-, third- or fourth-line treatment in terms of hazard ratio of overall survival in patients with gastric cancer who have relapsed after one treatment regimen containing a fluoropyrimidine (e.g., 5-FU, S-1, capecitabine and other 5-FU prodrugs or derivatives). Patients will be randomized in a 1:1 ratio for a total of 240 patients per treatment arm. Randomization will be stratified according to performance status (0-1 versus 2), prior taxan use (yes vs. no) and treatment line (2nd versus 3rd/4th line). Study treatment will be continued until progression or intolerable toxicity. Patients will be seen at baseline/screening, and weekly for paclitaxel administration and safety assessment until disease progression or discontinuation of trial therapy for other reasons. Radiological tumor assessment will be performed every second cycle (every 8 weeks) or earlier if clinically indicated. Post-study follow-up will be completed every 8 weeks for survival. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Lorenzen S, Knorrenschild JR, Pauligk C, Hegewisch-Becker S, Seraphin J, Thuss-Patience P, Kopp HG, Dechow T, Vogel A, Luley KB, Pink D, Stahl M, Kullmann F, Hebart H, Siveke J, Egger M, Homann N, Probst S, Goetze TO, Al-Batran SE. Phase III randomized, double-blind study of paclitaxel with and without everolimus in patients with advanced gastric or esophagogastric junction carcinoma who have progressed after therapy with a fluoropyrimidine/platinum-containing regimen (RADPAC). Int J Cancer. 2020 Nov 1;147(9):2493-2502. doi: 10.1002/ijc.33025. Epub 2020 May 7. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
300 | ||||
Original Estimated Enrollment ICMJE |
500 | ||||
Actual Study Completion Date ICMJE | October 2019 | ||||
Actual Primary Completion Date | July 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Germany | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01248403 | ||||
Other Study ID Numbers ICMJE | CRAD001RDE35T | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Prof. Dr. S.E. Al-Batran, Krankenhaus Nordwest | ||||
Original Responsible Party | PD Dr. Salah-Eddin Al-Batran, Krankenhaus Nordwest GmbH | ||||
Current Study Sponsor ICMJE | Krankenhaus Nordwest | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Krankenhaus Nordwest | ||||
Verification Date | January 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |