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A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)


N/A
20 Years
75 Years
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

5-year overall survival

Outcome Time Frame:

5 year after treatment

Safety Issue:

No

Principal Investigator

Joo-Hyun Nam, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Asan Medical Center Institutional Review Board

Study ID:

KGOG 1029

NCT ID:

NCT01680523

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical cancer
  • bulky early-stage
  • locally advanced
  • radical hysterectomy
  • concurrent chemoradiation therapy
  • Uterine Cervical Neoplasms

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