Clinical trial NCT01680523: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
bulky early-stage
locally advanced
radical hysterectomy
concurrent chemoradiation therapy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 409
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 year after treatment
Secondary outcomes:
measure: 5-year progression-free survival
timeFrame: 5 years after treatment
measure: Pattern of disease recurrence
timeFrame: within 5 years afer treatment
measure: Treatment-related toxicity
timeFrame: within 5 years after treatment
measure: Quality of life
timeFrame: within 1 year after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Joo-Hyun Nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: