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

NCT ID: NCT01680523

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2020-07-31

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

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RH group

Radical hysterectomy followed by tailored adjuvant therapy

Group Type: EXPERIMENTAL

Radical hysterectomy

Intervention Type: PROCEDURE

Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed

Tailored adjuvant therapy

Intervention Type: RADIATION

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.

CCRT group

Primary concurrent chemoradiation therapy

Group Type: ACTIVE_COMPARATOR

Primary chemoradiation therapy

Intervention Type: RADIATION

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.

Interventions

Radical hysterectomy

Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed

Intervention Type: PROCEDURE

Tailored adjuvant therapy

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

Primary chemoradiation therapy

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.

Intervention Type: RADIATION

Other Intervention Names

Adjuvant radiation therapy; Adjuvant chemoradiation therapy

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joo-Hyun Nam

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

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

Role: CONTACT

jhnam@amc.seoul.kr

82-2-3010-3633

Facility Contacts

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

Role: primary

jhnam@amc.seoul.kr

82-2-3010-3633

Other Identifiers

KGOG 1029

Identifier Type: -

Identifier Source: org_study_id