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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01680523
Recruitment Status : Recruiting
First Posted : September 7, 2012
Last Update Posted : May 31, 2017
Information provided by (Responsible Party):
Joo-Hyun Nam, 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

Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: Radical hysterectomy Radiation: Tailored adjuvant therapy Radiation: Primary chemoradiation therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
Study Start Date : September 2012
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RH group
Radical hysterectomy followed by tailored adjuvant therapy
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

Active Comparator: CCRT group
Primary concurrent 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.

Primary Outcome Measures :
  1. 5-year overall survival [ Time Frame: 5 year after treatment ]

Secondary Outcome Measures :
  1. 5-year progression-free survival [ Time Frame: 5 years after treatment ]
  2. Pattern of disease recurrence [ Time Frame: within 5 years afer treatment ]
  3. Treatment-related toxicity [ Time Frame: within 5 years after treatment ]
    Treatment related toxicity will be evaluated using CTCAE v3.0.

  4. Quality of life [ Time Frame: within 1 year after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01680523

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Contact: Joo-Hyun Nam, M.D., Ph.D. 82-2-3010-3633

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Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo-Hyun Nam, M.D., Ph.D.    82-2-3010-3633   
Sponsors and Collaborators
Asan Medical Center
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Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
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Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center Identifier: NCT01680523    
Other Study ID Numbers: KGOG 1029
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Keywords provided by Joo-Hyun Nam, Asan Medical Center:
cervical cancer
bulky early-stage
locally advanced
radical hysterectomy
concurrent chemoradiation therapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female