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.
Verified September 2012 by Asan Medical Center
Sponsor:
Asan Medical Center
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
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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:
|
|
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
- Squamous cell carcinoma
- Adenocarcinoma
- Adenosquamous carcinoma
- Gynecologic Oncology Group performance status: 0-2
Adequate organ function
- Bone marrow: WBC > 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100*103/mm3, Hemoglobin ≥ 10g/dL
- Kidney: Creatine < 1.25 * upper normal limit
- 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
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 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013