Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)

Not Applicable

• Conditions: Cervical Cancer
• Interventions: Radiation: Primary chemoradiation therapy; Procedure: Radical hysterectomy; Radiation: Tailored adjuvant therapy

• Registration Number: NCT01680523
• Lead Sponsor: Asan Medical Center

Brief Summary

To compare 5-year overall survival between patients who undergo radical hysterectomy followed by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO stage IB2 and IIA2 cervical cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-27
• Last Update Posted: 2017-05-31
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 409

Inclusion Criteria

• Previously untreated, histologically confirmed cervical cancer

• FIGO stage IB2 and IIA2 disease

• One of following histologic types

  1. Squamous cell carcinoma
  2. Adenocarcinoma
  3. Adenosquamous carcinoma

• Gynecologic Oncology Group performance status: 0-2

• Adequate organ function

  1. Bone marrow: WBC > 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100*103/mm3, Hemoglobin ≥ 10g/dL
  2. Kidney: Creatine < 1.25 * upper normal limit
  3. Liver: AST, ANT < 3 * upper normal limit, Total bilirubin < 1.5 mg/mm3

• Patient who have Singed an approved informed consent

Exclusion Criteria

• Patients with cervical cancer who have received any previous radiation or chemotherapy
• Neuroendocrine carcinoma of uterine cervix
• Occult cervical cancer which was found after simple hysterectomy
• Para-aortic nodal involvement (> 10 mm short axis diameter on pretreatment imaging study)
• History of other invasive malignancies, with the exception of non-melanoma skin cancer, in situ melanoma and thyroid cancer, who had (or have) no evidence of the other cancer present within the last 5 years
• Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Prior diagnosis of Crohn's disease or ulcerative colitis
• Neurologic or psychiatric disease
• Patients who are pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCRT group	Primary chemoradiation therapy	Primary concurrent chemoradiation therapy
RH group	Radical hysterectomy	Radical hysterectomy followed by tailored adjuvant therapy
RH group	Tailored adjuvant therapy	Radical hysterectomy followed by tailored adjuvant therapy

Primary Outcome Measures

Name	Time	Method
5-year overall survival	5 year after treatment

Secondary Outcome Measures

Name	Time	Method
Treatment-related toxicity	within 5 years after treatment	Treatment related toxicity will be evaluated using CTCAE v3.0.
5-year progression-free survival	5 years after treatment
Pattern of disease recurrence	within 5 years afer treatment
Quality of life	within 1 year after treatment

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of