Cervical cancer - null regimens

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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 cervical cancer page for regimens that include active anticancer treatment.
Last updated on 2024-12-02:3 regimens on this page
3 variants on this page
=Induction therapy=
==No induction 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
McCormack et al. 2024 (INTERLACE)	2012-11-08 to 2022-11-17	Phase 3 (C)	CP 	Shorter PFS/OS
No systemic therapy prior to definitive therapy.
====Subsequent treatment====
*Herod et al. 2000: Definitive RT
*INTERLACE: Cisplatin & RT consolidation
===References===
# 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 EuroPMC
#INTERLACE: McCormack M, Eminowicz G, Gallardo D, Diez P, Farrelly L, Kent C, Hudson E, Panades M, Mathew T, Anand A, Persic M, Forrest J, Bhana R, Reed N, Drake A, Adusumalli M, Mukhopadhyay A, King M, Whitmarsh K, McGrane J, Colombo N, Mak C, Mandal R, Chowdhury RR, Alamilla-Garcia G, Chávez-Blanco A, Stobart H, Feeney A, Vaja S, Hacker AM, Hackshaw A, Ledermann JA; INTERLACE investigators. Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE): an international, multicentre, randomised phase 3 trial. Lancet. 2024 Oct 19;404(10462):1525-1535. Epub 2024 Oct 14. link to original article EuroPMC NCT01566240
=Neoadjuvant therapy=
==No neoadjuvant therapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
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====
*Radical hysterectomy
===References===
# 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 EuroPMC
# 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 EuroPMC NCT00190528
=Adjuvant therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Mileshkin et al. 2023 (OUTBACK) 	2011-04-15 to 2017-06-26	Phase 3 (C)	Carboplatin & Paclitaxel	Did not meet primary endpoint of OS60OS60: 71% vs 72%
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====
*Definitive cisplatin-based chemo-radiation
===References===
#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 EuroPMC NCT02036164
#OUTBACK: Mileshkin LR, Moore KN, Barnes EH, Gebski V, Narayan K, King MT, Bradshaw N, Lee YC, Diamante K, Fyles AW, Small W Jr, Gaffney DK, Khaw P, Brooks S, Thompson JS, Huh WK, Mathews CA, Buck M, Suder A, Lad TE, Barani IJ, Holschneider CH, Van Dyk S, Quinn M, Rischin D, Monk BJ, Stockler MR. Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 May;24(5):468-482. Epub 2023 Apr 17. link to original article link to PMC article EuroPMC NCT01414608
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Category:Gynecologic cancers
Category:Null regimens