Here is the design of a clinical trial:

Official Title: A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer (Stage IA1 With LVSI, IA2)

Included conditions:
- Cervical Cancer

Study Armgroups:
- {'label': '1', 'type': 'EXPERIMENTAL', 'description': 'the group of LRH', 'interventionNames': ['Other: Total Laparoscopic or Robotic Radical Hysterectomy']}
- {'label': '2', 'type': 'ACTIVE_COMPARATOR', 'description': 'the group of ARH', 'interventionNames': ['Other: Total Abdominal Radical Hysterectomy']}

Interventions:
- {'type': 'OTHER', 'name': 'Total Laparoscopic or Robotic Radical Hysterectomy', 'description': 'Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1\\~2 cm of the parametrium and 1\\~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).', 'armGroupLabels': ['1']}
- {'type': 'OTHER', 'name': 'Total Abdominal Radical Hysterectomy', 'description': 'Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1\\~2 cm of the parametrium and 1\\~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).', 'armGroupLabels': ['2']}

Primary Outcomes:
- {'measure': 'the rate of PFS at 5 years', 'description': 'The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated.', 'timeFrame': '5 years from surgery'}

Please estimate the sample size based on the assumption: 
80% power, a one-sided alpha of 0.025, and a 10% drop-out rate.
Sample size calculation
          This study uses a non-inferiority trial design, and the primary outcome is the 5-year PFS rate. The sample size is calculated based on the difference between the two groups of 5-year PFS rate. The 5-year OS rate of the patients in the open surgery group is estimated to be 96% based on clinical data from our hospital, and the 5-year PFS rate is lacking. To infer the relationship between 5-year PFS rate and 5-year OS rate in patients undergoing open surgery, we refer to previous studies and construct a linear regression equation with 5-year OS rate as the independent variable X and 5-year PFS rate as the dependent variable Y (Yâ=â1.199 X-0.219). Therefore, the 5-year PFS rate of the open surgery group is estimated to be 93%, when the 5-year OS rate is 96%. Based on the assumptions of (i) a 5-year PFS rate of 93% in the open surgery group, (ii) a non-inferiority margin of 6%, (iii) 80% power, and (iv) a one-sided alpha of 0.025, the sample size estimation resulted in 308 subjects per group (calculated with SAS software, version 9.4). Considering a 10% drop-out rate and the randomization scheme with block size of 6, a total of 690 subjects should be randomized (345 per group).