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

NCT01680523 | Unknown DMC

• 1 other identifier: KGOG 1029
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 1

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

Keywords

cervical cancer; bulky early-stage; locally advanced; radical hysterectomy; concurrent chemoradiation therapy

Outcome Measures

Primary Outcomes (1)

• 5-year overall survival

  5 year after treatment

Secondary Outcomes (4)

• 5-year progression-free survival

  5 years after treatment

• Pattern of disease recurrence

  within 5 years afer treatment

• Treatment-related toxicity

  within 5 years after treatment

• Quality of life

  within 1 year after treatment

Study Arms (2)

RH group

EXPERIMENTAL

Radical hysterectomy followed by tailored adjuvant therapy

Procedure: Radical hysterectomy; Radiation: Tailored adjuvant therapy

CCRT group

ACTIVE COMPARATOR

Primary concurrent chemoradiation therapy

Radiation: Primary chemoradiation therapy

Interventions

Radical hysterectomy PROCEDURE

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

RH group

Tailored adjuvant therapy 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.

Also known as: Adjuvant radiation therapy, Adjuvant chemoradiation therapy

RH group

Primary chemoradiation therapy 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.

CCRT group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated, histologically confirmed cervical cancer
• FIGO stage IB2 and IIA2 disease
• One of following histologic types
• Squamous cell carcinoma
• Adenocarcinoma
• Adenosquamous carcinoma
• Gynecologic Oncology Group performance status: 0-2
• Adequate organ function
• Bone marrow: WBC \> 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100\*103/mm3, Hemoglobin ≥ 10g/dL
• Kidney: Creatine \< 1.25 \* upper normal limit
• Liver: AST, ANT \< 3 \* upper normal limit, Total bilirubin \< 1.5 mg/mm3
• Patient who have Singed an approved informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

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

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Joo-Hyun Nam, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82-2-3010-3633; jhnam@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

KR (1)