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Trial Title:
Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
NCT ID:
NCT01680523
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer
bulky early-stage
locally advanced
radical hysterectomy
concurrent chemoradiation therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Radical hysterectomy
Description:
Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open,
vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all
allowed
Arm group label:
RH group
Intervention type:
Radiation
Intervention name:
Tailored adjuvant therapy
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.
Arm group label:
RH group
Other name:
Adjuvant radiation therapy
Other name:
Adjuvant chemoradiation therapy
Intervention type:
Radiation
Intervention name:
Primary chemoradiation therapy
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.
Arm group label:
CCRT group
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
Criteria for eligibility:
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
Gender:
Female
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Address:
City:
Seoul
Zip:
138-736
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Joo-Hyun Nam, M.D., Ph.D.
Phone:
82-2-3010-3633
Email:
jhnam@amc.seoul.kr
Start date:
September 2012
Completion date:
July 2020
Lead sponsor:
Agency:
Asan Medical Center
Agency class:
Other
Source:
Asan Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01680523
