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
  Purpose

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 Intervention
Cervical Cancer
Procedure: Radical hysterectomy
Radiation: Tailored adjuvant therapy
Radiation: Primary chemoradiation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 5-year overall survival [ Time Frame: 5 year after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 409
Study Start Date: September 2012
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680523

Contacts
Contact: Joo-Hyun Nam, M.D., Ph.D. 82-2-3010-3633 jhnam@amc.seoul.kr

Locations
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    jhnam@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01680523     History of Changes
Other Study ID Numbers: KGOG 1029
Study First Received: September 4, 2012
Last Updated: September 8, 2012
Health Authority: Korea: Asan Medical Center Institutional Review Board

Keywords provided by Asan Medical Center:
cervical cancer
bulky early-stage
locally advanced
radical hysterectomy
concurrent chemoradiation therapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 14, 2014