Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer (STRATEGIC-1)
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|ClinicalTrials.gov Identifier: NCT01910610|
Recruitment Status : Recruiting
First Posted : July 29, 2013
Last Update Posted : June 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Biological: FOLFIRI-cetuximab Biological: mFOLFOX6-bevacizumab Biological: OPTIMOX-bevacizumab Biological: irinotecan-based chemo + bevacizumab Biological: Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab) Biological: XELOX + bevacizumab||Phase 3|
This is a phase III study assessing 2 mutli-line therapeutic strategies in patients with unresectable wild-type RAS metastatic colorectal cancer. All the available treatments are being used in each strategy (oxaliplatine, irinotecan, fluoropyrimidines, bevacizumab, cetuximab or panitumumab) but in a different order:
STRATEGY A: FOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab vs.
STRATEGY B: OPTIMOX-bevacizumab, followed by irinotecan-based chemotherapy with bevacizumab, followed by anti-EGFR mab with or without irinotecan.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||474 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Line Therapy Trial in Unresectable Wild-Type RAS Metastatic Colorectal Cancer. A GERCOR Randomized Open-label Phase III Study.|
|Actual Study Start Date :||October 30, 2013|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: STRATEGY A
FOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab
Biological: XELOX + bevacizumab
Experimental: STRATEGY B
OPTIMOX-bevacizumab, followed by irinotecan-based chemotherapy with bevacizumab, followed by anti-EGFR mab with or without irinotecan
Biological: irinotecan-based chemo + bevacizumab
Biological: Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)
Biological: XELOX + bevacizumab
- Duration of Disease Control (DDC) [ Time Frame: From baseline until end of strategy; up to 80 months after the beginning of the study ]DDC is defined as the sum of PFS of each active treatment course planned in the treatment strategy. DDC excludes 1) intervals between disease progression and re-initiation of treatment, and 2) PFS of inactive treatment if PD occurs at first evaluation after treatment re-initiation (either reintroduction in a stop-and-go strategy or subsequent course of treatment in a multi-line strategy).
- Assessment of Quality of life (QoL) [ Time Frame: From baseline until end of strategy; up to 80 months after the beginning of the study ]QoL will be considered to be improved if at least one time to QoL score deterioration (5 targeted dimensions) will be significantly longer without a significant shorter time to QoL score dimensions for other 4 targeted dimensions.
- Overall Survival (OS) [ Time Frame: Up to 80 months after the beginning of the study ]Time from randomization to the date of death from any cause
- Time to Failure of Strategy (TFS) [ Time Frame: Up to 80 months after the beginning of the study ]TFS is defined as beginning with the initiation of the strategy under investigation and ending with the first of the following events: 1) death, 2) disease progression on the last received planned sequence, 3) patient requires the addition of a new (unplanned) therapeutic agent, 4) patient experiences disease progression during a partial or complete break in therapy from initial treatment strategy and receives no further therapy within one month.
- Progression-free survival (PFS) per sequence of therapy [ Time Frame: Up to 80 months after the beginning of the study ]Time from randomization to the date of first documented disease progression or death from any cause, whichever occurs first.
- Tumor Response Rate (RR) [ Time Frame: From baseline until end of strategy; up to 80 months after the beginning of the study ]Tumor response will be assessed using RECIST version 1.1 per sequence of therapy
- Curative salvage surgery rate [ Time Frame: From baseline until end of strategy; up to 80 months after the beginning of the study ]The number of patient with R0 and R1 curative salvage surgery will be assessed globally (per arm) and per sequence of therapy
- Safety profile of each treatment sequence [ Time Frame: From study entry to 1 month after last study drug administration; up to 80 months after the beginning of the study ]The report will take into account all adverse events observed during and after drug administration, including any adverse events that may be related to the administration procedure itself.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910610
|Contact: Benoist Chibaudel, MD||+33(0)1 47 59 19 23|
|Principal Investigator:||Benoist Chibaudel, MD||Institut Hospitalier Franco-Britannique|