Difference between revisions of "Cervical cancer - null regimens"

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|1986-1995
 
|1986-1995
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
|[[#BIP_99|BIP]]
+
|[[#BIP_999|BIP]]
 
| style="background-color:#ffffbf" |Did not meet co-primary endpoints of ORR/OS
 
| style="background-color:#ffffbf" |Did not meet co-primary endpoints of ORR/OS
 
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|-
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|1996-2001
 
|1996-2001
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
|[[#Cisplatin_.26_Vincristine_99|Cisplatin & Vincristine]]
+
|[[#Cisplatin_.26_Vincristine_999|Cisplatin & Vincristine]]
 
| style="background-color:#ffffbf" |Did not meet co-primary endpoints of PFS/OS
 
| style="background-color:#ffffbf" |Did not meet co-primary endpoints of PFS/OS
 
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|-
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|2001-2005
 
|2001-2005
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
|[[#BOMP_99|BOMP]]
+
|[[#BOMP_999|BOMP]]
 
| 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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|2011-2017
 
|2011-2017
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
|[[#Carboplatin_.26_Paclitaxel_.28CP.29_99|Carboplatin & Paclitaxel]]
+
|[[#Carboplatin_.26_Paclitaxel_.28CP.29_999|Carboplatin & Paclitaxel]]
 
| 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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|-
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|2015-2017
 
|2015-2017
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
|[[#Carboplatin_.26_Paclitaxel_.28CP.29_99|Carboplatin & Paclitaxel]]
+
|[[#Carboplatin_.26_Paclitaxel_.28CP.29_999|Carboplatin & Paclitaxel]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
|-
 
|-

Revision as of 12:22, 18 June 2023

The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the main cervical cancer page for current regimens.


Neoadjuvant therapy

No neoadjuvant therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Herod et al. 2000 1986-1995 Phase 3 (C) BIP Did not meet co-primary endpoints of ORR/OS
Eddy et al. 2007 (GOG 141) 1996-2001 Phase 3 (C) Cisplatin & Vincristine Did not meet co-primary endpoints of PFS/OS
Katsumata et al. 2013 (JCOG 0102) 2001-2005 Phase 3 (C) BOMP Did not meet primary endpoint of OS

No systemic therapy prior to surgery.

Subsequent treatment

References

  1. Herod J, Burton A, Buxton J, Tobias J, Luesley D, Jordan S, Dunn J, Poole CJ. A randomised, prospective, phase III clinical trial of primary bleomycin, ifosfamide and cisplatin (BIP) chemotherapy followed by radiotherapy versus radiotherapy alone in inoperable cancer of the cervix. Ann Oncol. 2000 Sep;11(9):1175-81. link to original article PubMed
  2. GOG 141: Eddy GL, Bundy BN, Creasman WT, Spirtos NM, Mannel RS, Hannigan E, O'Connor D. Treatment of ("bulky") stage IB cervical cancer with or without neoadjuvant vincristine and cisplatin prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy: a phase III trial of the Gynecologic Oncology Group. Gynecol Oncol. 2007 Aug;106(2):362-9. Epub 2007 May 9. link to original article PubMed
  3. JCOG 0102: Katsumata N, Yoshikawa H, Kobayashi H, Saito T, Kuzuya K, Nakanishi T, Yasugi T, Yaegashi N, Yokota H, Kodama S, Mizunoe T, Hiura M, Kasamatsu T, Shibata T, Kamura T; JCOG. Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102). Br J Cancer. 2013 May 28;108(10):1957-63. Epub 2013 May 2. link to original article link to PMC article PubMed Clinical Trial Registry

Adjuvant therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (OUTBACK) 2011-2017 Phase 3 (C) Carboplatin & Paclitaxel Did not meet primary endpoint of OS
Tangjitgamol et al. 2019 (ACTLACC) 2015-2017 Phase 3 (C) Carboplatin & Paclitaxel Did not meet primary endpoint of PFS

No further treatment after definitive therapy.

Preceding treatment

References

  1. ACTLACC: Tangjitgamol S, Tharavichitkul E, Tovanabutra C, Rongsriyam K, Asakij T, Paengchit K, Sukhaboon J, Penpattanagul S, Kridakara A, Hanprasertpong J, Chomprasert K, Wanglikitkoon S, Atjimakul T, Pariyawateekul P, Katanyoo K, Tanprasert P, Janweerachai W, Sangthawan D, Khunnarong J, Chottetanaprasith T, Supawattanabodee B, Lertsanguansinchai P, Srisomboon J, Isaranuwatchai W, Lorvidhaya V. A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial. J Gynecol Oncol. 2019 Jul;30(4):e82. Epub 2019 Apr 10. link to original article link to PMC article PubMed Clinical Trial Registry
  2. OUTBACK: ACTRN12610000732088