Back to resultsRadical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
Primary Purpose
Cervical Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radical hysterectomy
Tailored adjuvant therapy
Primary chemoradiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer, bulky early-stage, locally advanced, radical hysterectomy, concurrent chemoradiation therapy
Eligibility 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
Sites / Locations
- Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RH group
CCRT group
Arm Description
Radical hysterectomy followed by tailored adjuvant therapy
Primary concurrent chemoradiation therapy
Outcomes
Primary Outcome Measures
5-year overall survival
Secondary Outcome Measures
5-year progression-free survival
Pattern of disease recurrence
Treatment-related toxicity
Treatment related toxicity will be evaluated using CTCAE v3.0.
Quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01680523
Brief Title
Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer, bulky early-stage, locally advanced, radical hysterectomy, concurrent chemoradiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
409 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RH group
Arm Type
Experimental
Arm Description
Radical hysterectomy followed by tailored adjuvant therapy
Arm Title
CCRT group
Arm Type
Active Comparator
Arm Description
Primary concurrent chemoradiation therapy
Intervention Type
Procedure
Intervention Name(s)
Radical hysterectomy
Intervention Description
Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed
Intervention Type
Radiation
Intervention Name(s)
Tailored adjuvant therapy
Other Intervention Name(s)
Adjuvant radiation therapy, Adjuvant chemoradiation therapy
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Primary chemoradiation therapy
Intervention Description
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 Measure Information:
Title
5-year overall survival
Time Frame
5 year after treatment
Secondary Outcome Measure Information:
Title
5-year progression-free survival
Time Frame
5 years after treatment
Title
Pattern of disease recurrence
Time Frame
within 5 years afer treatment
Title
Treatment-related toxicity
Description
Treatment related toxicity will be evaluated using CTCAE v3.0.
Time Frame
within 5 years after treatment
Title
Quality of life
Time Frame
within 1 year after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo-Hyun Nam, M.D., Ph.D.
Phone
82-2-3010-3633
Email
jhnam@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D.
Phone
82-2-3010-3633
Email
jhnam@amc.seoul.kr
12. IPD Sharing Statement
Learn more about this trial
Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
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