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dc.contributor.authorObermair, Andreas
dc.contributor.authorNicklin, Jim
dc.contributor.authorGebski, Val
dc.contributor.authorHayes, Sandra C
dc.contributor.authorGraves, Nicholas
dc.contributor.authorMileshkin, Linda
dc.contributor.authorLin, Ming Yin
dc.contributor.authorBeale, Phillip
dc.contributor.authorBaxter, Eva
dc.contributor.authorRobledo, Kristy
dc.contributor.authorSalomon, Carlos
dc.contributor.authorHanna, George B
dc.contributor.authorJanda, Monika
dc.date.accessioned2021-11-24T05:12:48Z
dc.date.available2021-11-24T05:12:48Z
dc.date.issued2021
dc.identifier.issn1048-891X
dc.identifier.doi10.1136/ijgc-2021-003029
dc.identifier.urihttp://hdl.handle.net/10072/410330
dc.description.abstractBackground Sentinel node biopsy is a surgical technique to explore lymph nodes for surgical staging of endometrial cancer, which has replaced full retroperitoneal lymph node dissection. However, the effectiveness of sentinel node biopsy, its value to patients, and potential harms compared with no-node dissection have never been shown in a randomized trial. Primary Objectives Stage 1 will test recovery from surgery. Stage 2 will compare disease-free survival at 4.5 years between patients randomized to sentinel node biopsy versus no retroperitoneal node dissection. Study Hypothesis The primary hypothesis for stage 1 is that treatment with sentinel node biopsy will not cause detriment to patient outcomes (lymphedema, morbidity, loss of quality of life) and will not increase treatment-related morbidity or health services costs compared with patients treated without a retroperitoneal node dissection at 12 months after surgery. The primary hypothesis for stage 2 is that disease-free survival at 4.5 years after surgery in patients without retroperitoneal node dissection is not inferior to those receiving sentinel node biopsy. Trial Design This phase III, open-label, two-arm, multistage, randomized non-inferiority trial (ENDO-3) will determine the value of sentinel node biopsy for surgical management of endometrial cancer. Patients with endometrial cancer are randomized to receive: (1) laparoscopic/robotic hysterectomy, bilateral salpingo-oophorectomy with sentinel node biopsy or (2) laparoscopic/robotic hysterectomy, bilateral salpingo-oophorectomy without retroperitoneal node dissection. In stage 1, 444 patients will be enrolled to demonstrate feasibility and quality of life. If this is demonstrated, we will enroll another 316 patients in stage 2. Major Inclusion and Exclusion Criteria Inclusion criteria include women aged 18 years or older with histologically confirmed endometrial cancer; clinical stage 1, who meet the criteria for laparoscopic or robotic total hysterectomy and bilateral salpingo-oophorectomy. Patients with uterine mesenchymal tumors are excluded. Primary Endpoints The endpoint for stage 1 is surgical recovery, with the proportion of patients returning to usual daily activities at 3 months post-surgery as measured with the EQ-5D. Stage 2 is disease-free survival at 4.5 years. Sample Size 760 participants (both stages). Estimated Dates for Completing Accrual and Presenting Results Stage 1 commenced in January 2021 and is planned to be completed in December 2024 when 444 participants have completed 12 months' follow-up. Stage 2 will enroll a further 316 participants for a total of 760 patients.
dc.description.peerreviewedYes
dc.languageeng
dc.publisherBMJ
dc.relation.ispartofjournalInternational Journal of Gynecologic Cancer
dc.subject.fieldofresearchOncology and carcinogenesis not elsewhere classified
dc.subject.fieldofresearchSurgery
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchOncology and carcinogenesis
dc.subject.fieldofresearchcode321199
dc.subject.fieldofresearchcode320226
dc.subject.fieldofresearchcode3202
dc.subject.fieldofresearchcode3211
dc.subject.keywordsgynecologic surgical procedures
dc.subject.keywordslymph nodes
dc.subject.keywordsoperative
dc.subject.keywordssurgical procedures
dc.subject.keywordsuterine cancer
dc.titleA phase III randomized clinical trial comparing sentinel node biopsy with no retroperitoneal node dissection in apparent early-stage endometrial cancer – ENDO-3: ANZGOG trial 1911/2020
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationObermair, A; Nicklin, J; Gebski, V; Hayes, SC; Graves, N; Mileshkin, L; Lin, MY; Beale, P; Baxter, E; Robledo, K; Salomon, C; Hanna, GB; Janda, M, A phase III randomized clinical trial comparing sentinel node biopsy with no retroperitoneal node dissection in apparent early-stage endometrial cancer - ENDO-3: ANZGOG trial 1911/2020, International Journal of Gynecologic Cancer, 2021
dcterms.dateAccepted2021-10-13
dc.date.updated2021-11-23T22:32:10Z
gro.hasfulltextNo Full Text
gro.griffith.authorHayes, Sandi C.


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