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

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

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

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Procedure: Radical hysterectomy; Radiation: Tailored adjuvant therapy; Radiation: Primary chemoradiation therapy

• Study Type: Interventional
• Enrollment (Anticipated): 409
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RH group; Radical hysterectomy followed by tailored adjuvant therapy	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.; Other Names: Adjuvant radiation therapy; Adjuvant chemoradiation therapy
ACTIVE_COMPARATOR: CCRT group; Primary concurrent chemoradiation therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
5-year overall survival	5 year after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year progression-free survival		5 years after treatment
Pattern of disease recurrence		within 5 years afer treatment
Treatment-related toxicity	Treatment related toxicity will be evaluated using CTCAE v3.0.	within 5 years after treatment
Quality of life		within 1 year after treatment

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (ESTIMATE): September 7, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 27, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: cervical cancer; locally advanced; bulky early-stage; radical hysterectomy; concurrent chemoradiation therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: KGOG 1029