Dataset Information

A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial.

ABSTRACT:

Background

Cervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs. In China, surgery to remove tumor burden followed by postoperative treatment with radiotherapy and chemotherapy based on clinicopathologic factors may be the best choice for stages IB3 and IIA2 patients. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology. The current trial is designed to evaluate whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB3 and IIA2) patient survival under stringent operation standards and consistent surgical oncologic principles. This paper reports the rationale, design, and implementation of the trial.

Methods/design

This is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 1104 patients with stage IB3 and IIA2 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary end point will be 5-year overall survival, and secondary endpoints include 5-year progression-free survival, recurrence, and quality of life measurements.

Discussion

The study results will provide more convincing evidence-based information for stages IB3 and IIA2 cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method.

Trial registration

ClinicalTrials.gov, NCT04939831 , retrospectively registered on 25 June 2021.

SUBMITTER: Wu X

PROVIDER: S-EPMC10436641 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial.

Wu Xin X Yu Hailin H Bai Yongrui Y Hou Yanli Y Lou Weihua W Wang Xipeng X Zhu Tao T Zhang Yuyang Y Hu Weiguo W Xue Xiaohong X Zhu Zhiling Z Xiang Libing L Li Jiarui J Fang Xuhong X Gao Shujun S Feng Hua H Diao Wenjing W Zhang Hongwei H Du Ming M Yan Weili W Qiu Ling L Feng Hao H Zhu Shurong S Du Yan Y Jiang Hua H

Trials 20230818 1

<h4>Background</h4>Cervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs. In China, surgery to remove tumor burden followed by postoperative treatment with radiotherapy and chemotherapy based on clinicopathologic factors may be the best choice for stages IB3 and IIA2 patients. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology. The current trial ...[more]

PMID: 37592299

Similar Datasets

Project description:OBJECTIVE:To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. DESIGN:Two parallel, multicentre, randomised trials. SETTING:28 UK centres and two South African centres. PARTICIPANTS:1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications. RESULTS:In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. CONCLUSIONS:Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.

Project description:This study is to compare the survival outcomes of laparoscopic radical hysterectomy (LRH) to those of abdominal radical hysterectomy (ARH) for patients with locally advanced cervical cancer (LACC). Patients with the International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2 to IIB LACC who underwent radical hysterectomy between 2001 and 2015 were identified. The disease-free survival (DFS) and overall survival (OS) were compared according to the surgical approach and were adjusted based on clinicopathologic characteristics. A total of 396 patients were included in the study, with 179 (45.2%) and 217 (54.8%) patients in the ARH and LRH groups, respectively. The LRH group showed a significantly lower amount of estimated blood loss, lower blood transfusion rate and shorter length of hospital stay. Overall, there were no significant differences in the 5-year DFS and 5-year OS between the LRH and ARH groups with the Kaplan-Meier method. However, multivariate analyses identified LRH as an independent prognostic factor for a poor DFS (hazard ratio [HR] 2.5; 95% confidence interval [95% CI] 0.19 to 0.87; p = 0.02). The analysis of stage IB2 disease and the squamous subtype (61.9% and 87.9% of all participants, respectively) reached the same conclusion. When stratifying by FIGO stage, the patients with IB2 (n = 348) in the ARH group had a significantly better DFS (HR 0.14, 95% CI 0.05-0.42, p < 0.01) and OS (HR 0.17, 95% CI 0.04-0.67, p = 0.11) than those in the LRH group in the Cox regression model. However, no differences were found in patient with stage IIA1, IIA2, or IIB in Cox regression model. When stratifying by histological types, for the patients with squamous carcinomas (n = 375), in Cox model, ARH had a significantly superior DFS compared with those who underwent LRH (HR 0.45, 95% CI 0.25-0.82, p = 0.01), but the OS was not statistically significant (HR 0.57, 95% CI 0.27-1.20, p = 0.14). However, no differences were found in patient with adenocarcinoma and adenosquamous carcinomas in the Cox model. Therefore, ARH was associated with a higher DFS than LRH in patients with LACC, especially in patients with stage IB2 disease or the squamous subtype.

Project description:Non-randomised studies have suggested that the postoperative complications of (Campos LS, Limberger LF, Stein AT, Kalil AN) laparoscopic radical hysterectomy are similar to those in abdominal radical hysterectomy. However, no study evaluating postoperative pain comparing both techniques has been published thus far. Our objective was to compare pain intensity and other perioperative outcomes between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in early cervical cancer.This single centre, randomised, controlled trial enrolled 30 cervical cancer patients who were clinically staged IA2 with lymph vascular invasion and IB according to the FIGO (International Federation of Gynaecology and Obstetrics) classification, and underwent LRH or ARH between late 1999 and early 2004. Postoperative pain, as measured by a 10-point numerical rate scale, was considered the primary endpoint. Postoperative pain was assessed every six hours during a patient's usual postoperative care. Perioperative outcomes were also registered. Both surgical techniques were executed by the same surgical team. Secondary outcomes included intraoperative and other postoperative surgicopathological factors and 5-year survival rates.IA2 patients with lymphatic vascular space invasion and IB cervical cancer patients were randomised to either the LRH group (16 patients) or the ARH group (14 patients). Four patients (25%) in the LRH group and 5 patients (36%) in the ARH group presented with transoperative or serious postoperative complications. All of the transoperative complications occurred in the LRH group. The relative risk of presenting with complications was 0.70; CI 95% (0.23-2.11); P?=?0.694. LRH group mean pain score was significantly lower than ARH after 36 h of observation (P?=?0.044; mean difference score: 1.42; 95% CI: 0.04-2.80). The survival results will be published elsewhere.LRH provided lower pain scores after 36 h of observation in this series. The perioperative and serious postoperative complications ratios were comparable between the groups.NCT01258413.

Project description:BackgroundTo investigate the survival outcomes of abdominal radical hysterectomy (ARH), laparoscopic radical hysterectomy (LRH), and vaginal-assisted laparoscopic radical hysterectomy (VALRH) in the treatment of cervical cancer patients.MethodsThis was a retrospective study. We collected the clinical data of 654 patients with cervical cancer (406 ARH, 172 LRH, and 76 VALRH), then compared the effects of different surgical methods on recurrence and survival.ResultsTotal overall survival (OS) were no significant differences in three groups (P>0.05). Total disease-free survival (DFS) was significantly higher in ARH group than in LRH group [hazard ratio (HR) =2.8, 95% confidence interval (CI): 1.199-3.607, P=0.004]; however, there were no significant differences between the VALRH (94.7%) and ARH (93.3%) groups. Subgroup stratification analysis showed that the overall recurrence rate in LRH group was significantly higher than that of the ARH groups for patients with a tumor size from ≥2 to <4 cm, negative postoperative lymph nodes, and no postoperative adjuvant therapy (all P<0.05). However, in the subgroup with tumor sizes of ≥2, <4, and ≥4 cm, no matter whether the lymph nodes were positive or not, and those with no postoperative supplementary adjuvant therapy, LRH was associated with a significantly higher local pelvic recurrence rate than ARH (all P<0.05). No significant differences between VALRH and ARH in any of the subgroup analyses (all P>0.05). A Cox analysis indicated that LRH increased the risk of overall and local pelvic recurrence after surgery compared with ARH (HR =2.338, 95% CI: 1.186-4.661, P=0.014; HR =10.313, 95% CI: 2.839-37.460, P<0.001); however, no significant difference between VALRH and ARH (all P>0.05). Sensitivity analysis of surgeons did not change the conclusions.ConclusionsOur analyses showed that the local pelvic recurrence rates and overall recurrence rates of LRH were significantly higher than ARH. VALRH could avoid tumor intraperitoneal exposure and achieve the same tumor prognosis as open surgery. By improving the standardization of minimally invasive surgery for early cervical cancer and paying close attention to the tumor-free concept, minimally invasive radical hysterectomy may achieve the same tumor outcome as open surgery.

Dataset Information

A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial.

Background

Methods/design

Discussion

Trial registration

Publications

A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets