CERVICAL NEOPLASMSPhase 2NCT00916500
Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer
A Phase 2 study testing CONCURRENT CHEMORADIATION (CISPLATIN) in people with CERVICAL NEOPLASMS, run by Korea Cancer Center Hospital at 1 site in South Korea.
Trial summary
Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical cancer. However, the most effective chemotherapy regimen is controversial. Weekly cisplatin, hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- CERVICAL NEOPLASMS
- What is being tested?
- CONCURRENT CHEMORADIATION (CISPLATIN)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2006to Dec 2013
- Phase
- Phase 2
- 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
- Histologically confirmed cervical cancer
- Clinical stage from 2b to 4a
- Equal to or younger than 75
- Gog performance status 0 - 2
- Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl
- Serum creatinine < 2.0
Show all 9Show fewer
- AST, ALT < 3 * upper normal level and serum bilirubin < 1.5 mg/dl
- Expected survival equal to or longer than 6 months
- Who agreed to participate in this study
Who cannot join
- History of chemotherapy or radiation to abdomen or pelvis
- History of other cancers
- Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2
- History of allergy or hypersensitivity reaction to platinum
- History of atrial or ventricular arrhythmia, or congestive heart failure
- Uncontrolled diabetes, hypertension, or ischemic heart disease
Show all 11Show fewer
- Myocardial infarction within 6 months
- Sepsis or severe infection
- Pregnant women
- An unapproved therapy within 30 days before enrollment
- Other serious diseases which can threat the safety of participants or impair the ability of participants to participate this trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences
Seoul, 139-706
About this study
Official title: A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients
Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical cancer.
However, the most effective chemotherapy regimen is controversial. Weekly cisplatin, hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials.
Read more
Weekly cisplatin needs frequent hospital visits and had a poor compliance profile in korea.
Combination chemotherapy regimens had more adverse effects than weekly cisplatin without improving outcomes.
We conducted a retrospective analysis comparing weekly cisplatin with cisplatin every 3 weeks and observed favorable outcome for cisplatin every 3 weeks regimen (still not published).
Therefore, we designed a phase 2 trial evaluating the efficacy and feasibility of CCRT with cisplatin every 3 weeks.
Read the detailed description
Cervical carcinoma is one of the most common gynecologic cancers worldwide. The prognosis of cervical cancer is favorable, with an approximately 80-90% 5-year survival rate in early-stage disease. However, advanced disease carries a poor prognosis.
Current standard treatment for locally advanced cervical cancer, which is not eligible for surgical treatment, is cisplatin-based concurrent chemoradiation. On the basis of the results of five randomized clinical trials, which consistently showed improved survival in patients treated with cisplatin-based chemoradiation, the U.S. National Cancer Institute (NCI) announced in 1992 that "Strong consideration should be given to the incorporation of concurrent cisplatin-based chemotherapy with radiotherapy in women who require radiotherapy for treatment of cervical cancer".
Although recently reported meta-analyses also demonstrated improved local control rates and survival with cisplatin-based chemotherapy concurrent with radiation, the optimal cisplatin dose and dosing schedule are still undetermined.
Among the previous five randomized clinical trials, two trials performed by the Gynecologic Oncology Group (GOG) used weekly cisplatin 40 mg/m2 while the other three trials used tri-weekly cisplatin at a dosage range of 50 mg/m2 to 75 mg/m2 combined with 5-fluorouracil (5-FU). Despite the diversity in cisplatin dose and dosing schedules, weekly cisplatin at a dose of 40 mg/m2 concurrent to RT is widely accepted as the standard regimen of CRT because of its convenience, equal effectiveness, and favorable toxicity in comparison to other 5-FU combined regimens.
However weekly cisplatin regimen needs frequent hospital visits and had a poor compliance profile in korea. With weekly cisplatin regimen, planned treatment was not completed in 58% patients adn treatment delayed in 29% patient. among these patients, 9% patients were not related associated toxicities.
To overcome toxicities and poor compliance of weekly regimen, the investigators tried to evaluate the efficacy and feasibility of CCRT with cisplatin 75mg/m2 every 3 weeks.
- Conditions
- CERVICAL NEOPLASMS
- Being tested
- CONCURRENT CHEMORADIATION (CISPLATIN)
- Keywords
- CERVICAL CANCER, CONCURRENT CHEMORADIATION, CISPLATIN
- 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.
CONCURRENT CHEMORADIATION (CISPLATIN)Drug
Also called Cisplatin
Cisplatin IV 75mg/m2 Every 3 Week For 3 Cycles; External Pelvic Radiation 40Gy; Brachytherapy Up To 85-90 Gy To Point A
| Study group | Role | What they receive |
|---|---|---|
| CISPLATIN | Experimental | Patients With Locally Advanced Cervical Cancer Who Underwent Concurrent Chemoradiation; Cisplatin 75mg/m2 IV Every 3 Week For 3 Cycles; External Pelvic Radiation 40 Gy; Brachytherapy Up to 85-90 Gy To Point A Receives: Drug: CONCURRENT CHEMORADIATION (CISPLATIN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DISEASE-FREE SURVIVAL
Measured: 5 YEAR AFTER THERAPY
Secondary outcomes (4)
DISEASE-FREE SURVIVAL
Measured: 2 YEAR AFTER THERAPY
OVERALL SURVIVAL
Measured: FROM THERAPY TO DEATH
RECURRENCE RATE
Measured: 2 YEAR AFTER THERAPY
RECURRENCE RATE
Measured: 5 YEAR AFTER THERAPY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startMar 2006
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CERVICAL NEOPLASMSStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Cancer Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Young Ryu, Korea Cancer Center Hospital
- Investigators
- SANG YOUNG RYU, M.D., Principal investigator, STAFF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916500
- Sponsor's protocol ID
- KCCH GY 1001
- Status last verified
- Apr 2014
- First submitted
- 7 Jun 2009
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT00916500
- Acronym / sponsor ID
- KCCH GY 1001
- Conditions
- CERVICAL NEOPLASMS
- Keywords
- CERVICAL CANCER, CONCURRENT CHEMORADIATION, CISPLATIN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Korea Cancer Center HospitalUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Jun 2009 (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.
Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical cancer.
However, the most effective chemotherapy regimen is controversial. Weekly cisplatin, hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials.
Weekly cisplatin needs frequent hospital visits and had a poor compliance profile in korea.
Combination chemotherapy regimens had more adverse effects than weekly cisplatin without improving outcomes.
We conducted a retrospective analysis comparing weekly cisplatin with cisplatin every 3 weeks and observed favorable outcome for cisplatin every 3 weeks regimen (still not published).
Therefore, we designed a phase 2 trial evaluating the efficacy and feasibility of CCRT with cisplatin every 3 weeks.
Detailed description
Cervical carcinoma is one of the most common gynecologic cancers worldwide. The prognosis of cervical cancer is favorable, with an approximately 80-90% 5-year survival rate in early-stage disease. However, advanced disease carries a poor prognosis.
Current standard treatment for locally advanced cervical cancer, which is not eligible for surgical treatment, is cisplatin-based concurrent chemoradiation. On the basis of the results of five randomized clinical trials, which consistently showed improved survival in patients treated with cisplatin-based chemoradiation, the U.S. National Cancer Institute (NCI) announced in 1992 that "Strong consideration should be given to the incorporation of concurrent cisplatin-based chemotherapy with radiotherapy in women who require radiotherapy for treatment of cervical cancer".
Although recently reported meta-analyses also demonstrated improved local control rates and survival with cisplatin-based chemotherapy concurrent with radiation, the optimal cisplatin dose and dosing schedule are still undetermined.
Among the previous five randomized clinical trials, two trials performed by the Gynecologic Oncology Group (GOG) used weekly cisplatin 40 mg/m2 while the other three trials used tri-weekly cisplatin at a dosage range of 50 mg/m2 to 75 mg/m2 combined with 5-fluorouracil (5-FU). Despite the diversity in cisplatin dose and dosing schedules, weekly cisplatin at a dose of 40 mg/m2 concurrent to RT is widely accepted as the standard regimen of CRT because of its convenience, equal effectiveness, and favorable toxicity in comparison to other 5-FU combined regimens.
However weekly cisplatin regimen needs frequent hospital visits and had a poor compliance profile in korea. With weekly cisplatin regimen, planned treatment was not completed in 58% patients adn treatment delayed in 29% patient. among these patients, 9% patients were not related associated toxicities.
To overcome toxicities and poor compliance of weekly regimen, the investigators tried to evaluate the efficacy and feasibility of CCRT with cisplatin 75mg/m2 every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CISPLATIN | Experimental | Drug: CONCURRENT CHEMORADIATION (CISPLATIN)Patients With Locally Advanced Cervical Cancer Who Underwent Concurrent Chemoradiation; Cisplatin 75mg/m2 IV Every 3 Week For 3 Cycles; External Pelvic Radiation 40 Gy; Brachytherapy Up to 85-90 Gy To Point A |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed cervical cancer
- Clinical stage from 2b to 4a
- Equal to or younger than 75
- Gog performance status 0 - 2
- Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl
Key exclusion criteria (11 listed)
- History of chemotherapy or radiation to abdomen or pelvis
- History of other cancers
- Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2
- History of allergy or hypersensitivity reaction to platinum
- History of atrial or ventricular arrhythmia, or congestive heart failure
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 |
|---|---|---|
| CONCURRENT CHEMORADIATION (CISPLATIN)Also: CisplatinCisplatin IV 75mg/m2 Every 3 Week For 3 Cycles; External Pelvic Radiation 40Gy; Brachytherapy Up To 85-90 Gy To Point A | Drug | CISPLATIN |
Primary outcome
DISEASE-FREE SURVIVAL
Time frame: 5 YEAR AFTER THERAPY
4 secondary outcomes
DISEASE-FREE SURVIVAL
Time frame: 2 YEAR AFTER THERAPY
OVERALL SURVIVAL
Time frame: FROM THERAPY TO DEATH
RECURRENCE RATE
Time frame: 2 YEAR AFTER THERAPY
RECURRENCE RATE
Time frame: 5 YEAR AFTER THERAPY
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
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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.
SANG YOUNG RYU, M.D. principal investigator
STAFF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CONCURRENT CHEMORADIATION (CISPLATIN) in people with CERVICAL NEOPLASMS, run by Korea Cancer Center Hospital 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 1 May 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DISEASE-FREE SURVIVAL (time frame: 5 YEAR AFTER THERAPY). 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 1 May 2014.