Cervical CancerNCT01680523
Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
A study testing Radical hysterectomy, Tailored adjuvant therapy and Primary chemoradiation therapy in people with Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Radical hysterectomy, Tailored adjuvant therapy and Primary chemoradiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated, histologically confirmed cervical cancer
- FIGO stage IB2 and IIA2 disease
- One of following histologic types
- Squamous cell carcinoma
- Adenocarcinoma
- Adenosquamous carcinoma
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- 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
Who cannot join
- 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
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- Prior diagnosis of Crohn's disease or ulcerative colitis
- Neurologic or psychiatric disease
- Patients who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
Joo-Hyun Nam, M.D., Ph.D., 82-2-3010-3633, jhnam@amc.seoul.kr
About this study
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)
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
- Being tested
- Radical hysterectomy, Tailored adjuvant therapy, Primary chemoradiation therapy
- Keywords
- cervical cancer, bulky early-stage, locally advanced, radical hysterectomy, concurrent chemoradiation therapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical hysterectomyProcedure or surgery
Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed
Tailored adjuvant therapyRadiation
Also called Adjuvant radiation therapy, Adjuvant chemoradiation 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 therapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| RH group | Experimental | Radical hysterectomy followed by tailored adjuvant therapy Receives: Procedure: Radical hysterectomy; Radiation: Tailored adjuvant therapy |
| CCRT group | Active comparator | Primary concurrent chemoradiation therapy Receives: Radiation: Primary chemoradiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
Measured: 5 year after treatment
Secondary outcomes (4)
5-year progression-free survival
Measured: 5 years after treatment
Pattern of disease recurrence
Measured: within 5 years afer treatment
Treatment-related toxicity
Treatment related toxicity will be evaluated using CTCAE v3.0.
Measured: within 5 years after treatment
Quality of life
Measured: within 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 409 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo-Hyun Nam, Asan Medical Center
- Investigators
- Joo-Hyun Nam, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680523
- Sponsor's protocol ID
- KGOG 1029
- Status last verified
- May 2017
- First submitted
- 4 Sep 2012
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01680523
- Acronym / sponsor ID
- KGOG 1029
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, bulky early-stage, locally advanced, radical hysterectomy, concurrent chemoradiation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 409 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RH group | Experimental | Procedure: Radical hysterectomy, Radiation: Tailored adjuvant therapyRadical hysterectomy followed by tailored adjuvant therapy |
| CCRT group | Active comparator | Radiation: Primary chemoradiation therapyPrimary concurrent chemoradiation therapy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Previously untreated, histologically confirmed cervical cancer
- FIGO stage IB2 and IIA2 disease
- One of following histologic types
- Gynecologic Oncology Group performance status: 0-2
- Adequate organ function
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical hysterectomyPiver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed | Procedure or surgery | RH group |
| Tailored adjuvant therapyAlso: Adjuvant radiation therapy, Adjuvant chemoradiation therapyAfter 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. | Radiation | RH group |
| Primary chemoradiation therapyPatient 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. | Radiation | CCRT group |
Primary outcome
5-year overall survival
Time frame: 5 year after treatment
4 secondary outcomes
5-year progression-free survival
Time frame: 5 years after treatment
Pattern of disease recurrence
Time frame: within 5 years afer treatment
Treatment-related toxicity
Time frame: within 5 years after treatment
Quality of life
Time frame: within 1 year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo-Hyun Nam, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical hysterectomy, Tailored adjuvant therapy and Primary chemoradiation therapy in people with Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joo-Hyun Nam, M.D., Ph.D. (82-2-3010-3633, jhnam@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (time frame: 5 year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.