Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)

Asan Medical Center

Status: Unknown

Conditions: Cervical Cancer

Treatments: Radiation: Tailored adjuvant therapy; Procedure: Radical hysterectomy; Radiation: Primary chemoradiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01680523

KGOG 1029

Details and patient eligibility

About

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

Enrollment: 409 estimated patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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409 participants in 2 patient groups

RH group

Experimental group

Description:

Radical hysterectomy followed by tailored adjuvant therapy

Treatment:

Procedure: Radical hysterectomy

Radiation: Tailored adjuvant therapy

CCRT group

Active Comparator group

Description:

Primary concurrent chemoradiation therapy

Treatment:

Radiation: Primary chemoradiation therapy