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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01680523
First received: September 4, 2012
Last updated: September 8, 2012
Last verified: September 2012

September 4, 2012
September 8, 2012
September 2012
July 2020   (final data collection date for primary outcome measure)
5-year overall survival [ Time Frame: 5 year after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01680523 on ClinicalTrials.gov Archive Site
  • 5-year progression-free survival [ Time Frame: 5 years after treatment ] [ Designated as safety issue: No ]
  • Pattern of disease recurrence [ Time Frame: within 5 years afer treatment ] [ Designated as safety issue: No ]
  • Treatment-related toxicity [ Time Frame: within 5 years after treatment ] [ Designated as safety issue: Yes ]
    Treatment related toxicity will be evaluated using CTCAE v3.0.
  • Quality of life [ Time Frame: within 1 year after treatment ] [ Designated as safety issue: No ]
  • 5-year progression-free survival [ Time Frame: 5 years after treatment ] [ Designated as safety issue: No ]
  • Pattern of disease recurrence [ Time Frame: within 5 years afer treatment ] [ Designated as safety issue: No ]
  • Treatment-related toxicity [ Time Frame: within 5 years after treatment ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: within 1 year after treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Cancer
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
409
Not Provided
July 2020   (final data collection date for primary outcome measure)

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
Female
20 Years to 75 Years
No
Contact: Joo-Hyun Nam, M.D., Ph.D. 82-2-3010-3633 jhnam@amc.seoul.kr
Korea, Republic of
 
NCT01680523
KGOG 1029
Yes
Joo-Hyun Nam, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
Asan Medical Center
September 2012

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