Difference between revisions of "Gallbladder cancer - null regimens"
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− | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Gallbladder cancer|main gallbladder cancer page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[https://www.clinicaltrials.gov/ | + | |[https://www.clinicaltrials.gov/study/NCT04559139 Awaiting publication (ECOG-ACRIN EA2197)] |
|2020-ongoing | |2020-ongoing | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[#Cisplatin_.26_Gemcitabine_.28GC. | + | |[[#Cisplatin_.26_Gemcitabine_.28GC.29_666|GC]] |
− | | style="background-color:#d3d3d3" | | + | | style="background-color:#d3d3d3" |TBD if different primary endpoint of OS |
|- | |- | ||
|} | |} | ||
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</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | #'''ECOG-ACRIN EA2197:''' NCT04559139 | + | #'''ECOG-ACRIN EA2197:''' [https://clinicaltrials.gov/study/NCT04559139 NCT04559139] |
=Adjuvant therapy= | =Adjuvant therapy= | ||
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|rowspan=2|2006-2008 | |rowspan=2|2006-2008 | ||
| style="background-color:#1a9851" rowspan="2" |Randomized (C) | | style="background-color:#1a9851" rowspan="2" |Randomized (C) | ||
− | |1. [[# | + | |1. [[#FUFA_999|FUFA]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
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===References=== | ===References=== | ||
− | #Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. [https://doi.org/10.1200/JCO.2010.29.3605 link to original article] | + | #Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. [https://doi.org/10.1200/JCO.2010.29.3605 link to original article] [https://pubmed.ncbi.nlm.nih.gov/20855823/ PubMed] |
[[Category:Gallbladder cancer regimens]] | [[Category:Gallbladder cancer regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
− | [[Category: | + | [[Category:Biliary tract cancers]] |
[[Category:Null regimens]] | [[Category:Null regimens]] |
Latest revision as of 00:56, 27 January 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main gallbladder cancer page for regimens that include active anticancer treatment.
Neoadjuvant therapy
No neoadjuvant therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Awaiting publication (ECOG-ACRIN EA2197) | 2020-ongoing | Phase 3 (C) | GC | TBD if different primary endpoint of OS |
No systemic therapy prior to surgery.
Subsequent treatment
References
- ECOG-ACRIN EA2197: NCT04559139
Adjuvant therapy
Observation
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Nakachi et al 2023 (ASCOT) | 2013-09-09 to 2018-06-22 | Phase 3 (C) | S-1 | Inferior OS |
No systemic therapy after surgery.
Preceding treatment
References
- ASCOT: Nakachi K, Ikeda M, Konishi M, Nomura S, Katayama H, Kataoka T, Todaka A, Yanagimoto H, Morinaga S, Kobayashi S, Shimada K, Takahashi Y, Nakagohri T, Gotoh K, Kamata K, Shimizu Y, Ueno M, Ishii H, Okusaka T, Furuse J; Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG). Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 2023 Jan 21;401(10372):195-203. PMID: 36681415. link to original article PubMed UMIN000011688
Metastatic or unresectable disease, all lines of therapy
Best supportive care
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Sharma et al. 2010 | 2006-2008 | Randomized (C) | 1. FUFA | Did not meet primary endpoint of OS |
2. mGEMOX | Seems to have inferior OS |
No active antineoplastic treatment.
References
- Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. link to original article PubMed