CERVANTES: an international randomized trial of radical surgery
followed by adjuvant (chemo) radiation versus no further
treatment in patients with early-stage, intermediate-risk
cervical cancer (CEEGOG-CX-05; ENGOT-CX16)

J 2022

CERVANTES: an international randomized trial of radical surgery followed by adjuvant (chemo) radiation versus no further treatment in patients with early-stage, intermediate-risk cervical cancer (CEEGOG-CX-05; ENGOT-CX16)

CIBULA, David, Martina BORCINOVA, Roman KOCIAN, David FELTL, Sona ARGALACSOVA et. al.

Základní údaje

Originální název

CERVANTES: an international randomized trial of radical surgery followed by adjuvant (chemo) radiation versus no further treatment in patients with early-stage, intermediate-risk cervical cancer (CEEGOG-CX-05; ENGOT-CX16)

Autoři

CIBULA, David (203 Česká republika, garant), Martina BORCINOVA (203 Česká republika), Roman KOCIAN (203 Česká republika), David FELTL (203 Česká republika), Sona ARGALACSOVA (203 Česká republika), Pavel DVORAK (203 Česká republika), Daniela FISCHEROVA (203 Česká republika), Pavel DUNDR (203 Česká republika), Jiří JARKOVSKÝ (203 Česká republika, domácí), Eva HOSCHLOVA (203 Česká republika), Jiri SLAMA (203 Česká republika) a Giovanni SCAMBIA (203 Česká republika)

Vydání

International Journal of Gynecological Cancer, LONDON, BMJ PUBLISHING GROUP, 2022, 1048-891X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30214 Obstetrics and gynaecology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 4.800

Kód RIV

RIV/00216224:14110/22:00128275

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1136/ijgc-2022-003918

UT WoS

000853817200001

Klíčová slova anglicky

Cervical Cancer; Surgical Oncology; Radiotherapy

Štítky

14119612, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 25. 1. 2023 13:30, Mgr. Tereza Miškechová

Anotace

V originále

Background The role of adjuvant treatment in the intermediate-risk group of patients with early-stage cervical cancer is controversial and is supported by a single randomized Gynecologic Oncology Group (GOG) 92 study performed more than 20 years ago. Recent retrospective studies have shown excellent local control in this group of patients after radical surgery with no additional adjuvant treatment. Primary Objective To evaluate if adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with intermediate-risk cervical cancer. Study Hypothesis Radical surgery alone is non-inferior to the combined treatment of radical surgery followed by adjuvant (chemo)radiation in disease-free survival in patients with intermediate-risk cervical cancer. Trial Design This is a phase III, international, multicenter, randomized, non-inferiority trial in which patients with intermediate-risk cervical cancer will be randomized 1:1 into arm A, with no additional treatment after radical surgery, and arm B, receiving adjuvant external beam radiotherapy +/- brachytherapy +/- concomitant chemotherapy. Patient data will be collected over 3 years post-randomization of the last enrolled patient for primary endpoint analysis or for 6 years for the overall survival analysis. Major Inclusion/Exclusion Criteria Patients with intermediate-risk early-stage cervical cancer (IB1-IIA), defined as lymph node-negative patients with a combination of negative prognostic factors (tumor size >4 cm; tumor size >2 cm and lymphovascular space invasion; deep stromal invasion >2/3; or tumor-free distance <3 mm) with squamous cell carcinoma or human papillomavirus (HPV)-related adenocarcinoma, are eligible for the trial. Primary Endpoint Disease-free survival defined as time from randomization to recurrence diagnosis. Sample Size 514 patients from up to 90 sites will be randomized. Estimated Dates for Completing Accrual and Presenting Results It is estimated that the accrual will be completed by 2027 (with 3 additional years of follow-up) and primary endpoint results will be published by 2031. Estimated trial completion is by 2034.

Citovat

CIBULA, David, Martina BORCINOVA, Roman KOCIAN, David FELTL, Sona ARGALACSOVA, Pavel DVORAK, Daniela FISCHEROVA, Pavel DUNDR, Jiří JARKOVSKÝ, Eva HOSCHLOVA, Jiri SLAMA a Giovanni SCAMBIA. CERVANTES: an international randomized trial of radical surgery followed by adjuvant (chemo) radiation versus no further treatment in patients with early-stage, intermediate-risk cervical cancer (CEEGOG-CX-05; ENGOT-CX16). International Journal of Gynecological Cancer. LONDON: BMJ PUBLISHING GROUP, 2022, roč. 32, č. 10, s. 1327-1331. ISSN 1048-891X. Dostupné z: https://dx.doi.org/10.1136/ijgc-2022-003918.

@article{2249618,
   author = {Cibula, David and Borcinova, Martina and Kocian, Roman and Feltl, David and Argalacsova, Sona and Dvorak, Pavel and Fischerova, Daniela and Dundr, Pavel and Jarkovský, Jiří and Hoschlova, Eva and Slama, Jiri and Scambia, Giovanni},
   article_location = {LONDON},
   article_number = {10},
   doi = {http://dx.doi.org/10.1136/ijgc-2022-003918},
   keywords = {Cervical Cancer; Surgical Oncology; Radiotherapy},
   language = {eng},
   issn = {1048-891X},
   journal = {International Journal of Gynecological Cancer},
   title = {CERVANTES: an international randomized trial of radical surgery followed by adjuvant (chemo) radiation versus no further treatment in patients with early-stage, intermediate-risk cervical cancer (CEEGOG-CX-05; ENGOT-CX16)},
   url = {https://ijgc.bmj.com/content/32/10/1327},
   volume = {32},
   year = {2022}
}

TY  - JOUR
ID  - 2249618
AU  - Cibula, David - Borcinova, Martina - Kocian, Roman - Feltl, David - Argalacsova, Sona - Dvorak, Pavel - Fischerova, Daniela - Dundr, Pavel - Jarkovský, Jiří - Hoschlova, Eva - Slama, Jiri - Scambia, Giovanni
PY  - 2022
TI  - CERVANTES: an international randomized trial of radical surgery followed by adjuvant (chemo) radiation versus no further treatment in patients with early-stage, intermediate-risk cervical cancer (CEEGOG-CX-05; ENGOT-CX16)
JF  - International Journal of Gynecological Cancer
VL  - 32
IS  - 10
SP  - 1327-1331
EP  - 1327-1331
PB  - BMJ PUBLISHING GROUP
SN  - 1048891X
KW  - Cervical Cancer
KW  - Surgical Oncology
KW  - Radiotherapy
UR  - https://ijgc.bmj.com/content/32/10/1327
N2  - Background The role of adjuvant treatment in the intermediate-risk group of patients with early-stage cervical cancer is controversial and is supported by a single randomized Gynecologic Oncology Group (GOG) 92 study performed more than 20 years ago. Recent retrospective studies have shown excellent local control in this group of patients after radical surgery with no additional adjuvant treatment. Primary Objective To evaluate if adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with intermediate-risk cervical cancer. Study Hypothesis Radical surgery alone is non-inferior to the combined treatment of radical surgery followed by adjuvant (chemo)radiation in disease-free survival in patients with intermediate-risk cervical cancer. Trial Design This is a phase III, international, multicenter, randomized, non-inferiority trial in which patients with intermediate-risk cervical cancer will be randomized 1:1 into arm A, with no additional treatment after radical surgery, and arm B, receiving adjuvant external beam radiotherapy +/- brachytherapy +/- concomitant chemotherapy. Patient data will be collected over 3 years post-randomization of the last enrolled patient for primary endpoint analysis or for 6 years for the overall survival analysis. Major Inclusion/Exclusion Criteria Patients with intermediate-risk early-stage cervical cancer (IB1-IIA), defined as lymph node-negative patients with a combination of negative prognostic factors (tumor size >4 cm; tumor size >2 cm and lymphovascular space invasion; deep stromal invasion >2/3; or tumor-free distance <3 mm) with squamous cell carcinoma or human papillomavirus (HPV)-related adenocarcinoma, are eligible for the trial. Primary Endpoint Disease-free survival defined as time from randomization to recurrence diagnosis. Sample Size 514 patients from up to 90 sites will be randomized. Estimated Dates for Completing Accrual and Presenting Results It is estimated that the accrual will be completed by 2027 (with 3 additional years of follow-up) and primary endpoint results will be published by 2031. Estimated trial completion is by 2034.
ER  -

CIBULA, David, Martina BORCINOVA, Roman KOCIAN, David FELTL, Sona ARGALACSOVA, Pavel DVORAK, Daniela FISCHEROVA, Pavel DUNDR, Jiří JARKOVSKÝ, Eva HOSCHLOVA, Jiri SLAMA a Giovanni SCAMBIA. CERVANTES: an international randomized trial of radical surgery followed by adjuvant (chemo) radiation versus no further treatment in patients with early-stage, intermediate-risk cervical cancer (CEEGOG-CX-05; ENGOT-CX16). \textit{International Journal of Gynecological Cancer}. LONDON: BMJ PUBLISHING GROUP, 2022, roč.~32, č.~10, s.~1327-1331. ISSN~1048-891X. Dostupné z: https://dx.doi.org/10.1136/ijgc-2022-003918.

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