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

Cervical Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01680523
• Other study ID #: KGOG 1029
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2012
• Last updated: May 27, 2017
• Start date: September 2012
• Est. completion date: July 2020

Study information

• Verified date: May 2017
• Source: Asan Medical Center
• Contact: Joo-Hyun Nam, M.D., Ph.D.
• Phone: 82-2-3010-3633
• Email: jhnam[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 409
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Radiation:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year overall survival		5 year after treatment
Secondary	5-year progression-free survival		5 years after treatment
Secondary	Pattern of disease recurrence		within 5 years afer treatment
Secondary	Treatment-related toxicity	Treatment related toxicity will be evaluated using CTCAE v3.0.	within 5 years after treatment
Secondary	Quality of life		within 1 year after treatment