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

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ClinicalTrials.gov Identifier: NCT01680523
Recruitment Status : Unknown
Verified May 2017 by Joo-Hyun Nam, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : September 7, 2012
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 7, 2012
Last Update Posted Date May 31, 2017
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
5-year overall survival [ Time Frame: 5 year after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2012)
  • 5-year progression-free survival [ Time Frame: 5 years after treatment ]
  • Pattern of disease recurrence [ Time Frame: within 5 years afer treatment ]
  • Treatment-related toxicity [ Time Frame: within 5 years after treatment ]
    Treatment related toxicity will be evaluated using CTCAE v3.0.
  • Quality of life [ Time Frame: within 1 year after treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • 5-year progression-free survival [ Time Frame: 5 years after treatment ]
  • Pattern of disease recurrence [ Time Frame: within 5 years afer treatment ]
  • Treatment-related toxicity [ Time Frame: within 5 years after treatment ]
  • Quality of life [ Time Frame: within 1 year after treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
Official Title  ICMJE A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Procedure: Radical hysterectomy
    Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed
  • Radiation: Tailored adjuvant therapy
    After radical hysterectomy, intermediate risk group according to GOG protocol 92 criteria will receive adjuvant radiation therapy. High risk group will receive adjuvant chemoradiation therapy with weekly cisplatin (40mg/m2, IV for 6 cycles). Extended filed radiation therapy is allowed in case of common iliac lymph node or para-aortic lymph node metastasis. Intracavitary brachytherapy and nodal or parametrial boost is not allowed.
    Other Names:
    • Adjuvant radiation therapy
    • Adjuvant chemoradiation therapy
  • Radiation: Primary chemoradiation therapy
    Patient will receive primary radiation therapy including external pelvic irradiation, intracavitary brachytherapy, and parametrial or nodal boost. Extended filed radiation therapy is allowed in case of common iliac lymph node enlargement. Patients will receive concurrent weekly cisplatin (cisplatin 40mg/m2 for 6 cycles) during external radiation therapy.
Study Arms  ICMJE
  • Experimental: RH group
    Radical hysterectomy followed by tailored adjuvant therapy
    Interventions:
    • Procedure: Radical hysterectomy
    • Radiation: Tailored adjuvant therapy
  • Active Comparator: CCRT group
    Primary concurrent chemoradiation therapy
    Intervention: Radiation: Primary chemoradiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 6, 2012)
409
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01680523
Other Study ID Numbers  ICMJE KGOG 1029
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joo-Hyun Nam, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
PRS Account Asan Medical Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP