Cervical CancersPhase 3NCT01097252
Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer
A Phase 3 study testing radiation, weekly cisplatin and tri-weekly cisplatin in people with Cervical Cancers, run by Korea Cancer Center Hospital at 1 site in South Korea.
Trial summary
Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Cervical Cancers
- What is being tested?
- radiation, weekly cisplatin and tri-weekly cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2002to Dec 2009
- Phase
- Phase 3
- 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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven cervical cancer
- Squamous, Adenosquamous, Adeno carcinoma cell type
- International Federation of Gynecologic Oncology (FIGO) stage IIB - IVA
- Gynecologic Oncology Group (GOG) performance status 0 - 2
Who cannot join
- Previous history of chemotherapy or radiation
- History of other cancer
- Hypersensitivity to platinum agents
- Pregnancy
- Serious medical disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea Institute of Radiological & Medical Sciences
Seoul, 139-706
About this study
Official title: Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.
Read the detailed description
This study is to compare the compliance, toxicity, response and survival rate between concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in patients with advanced cervical cancer. Patients with primary untreated invasive squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA were enrolled. Patients with histologically proven locoregionally advanced cervical cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.
- Conditions
- Cervical Cancers
- Being tested
- radiation, weekly cisplatin, tri-weekly cisplatin
- Keywords
- Cervical Neoplasm, chemoradiation, compliance, toxicity
- Medical subject headings
- Uterine Cervical Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiationRadiation
radiation with cisplatin 40mg/m2, 6 cycles, every week
weekly cisplatinDrug
Also called Cisplatin
weekly cisplatin 40mg/m2, 6 cycles
tri-weekly cisplatinDrug
Also called Cisplatin
cisplatin 75mg/m2, 3cycles, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| weekly cisplatin | Active comparator | Weekly cisplatin 40mg/m2 during radiation therapy Receives: Radiation: radiation; Drug: weekly cisplatin |
| tri-weekly cisplatin | Experimental | cisplatin 75mg/m2 three cycles, every 3 weeks Receives: Radiation: radiation; Drug: tri-weekly cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance
- Percentage of completed cycles of scheduled chemotherapy in each arm
- Percentage of grade III and IV toxicity
- Delayed radiation time due to toxicity
Measured: 3 month
Secondary outcomes (1)
survival
- 5 year progression free survival
- 5 year survival rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startJan 2002
- Primary completionDec 2004
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 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, MD, Principal investigator, Korea Institute of Radiological & Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097252
- Sponsor's protocol ID
- KCCH GY 1005
- Status last verified
- May 2014
- First submitted
- 29 Mar 2010
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ryu SY, Lee WM, Kim K, Park SI, Kim BJ, Kim MH, Choi SC, Cho CK, Nam BH, Lee ED. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e577-81. doi: 10.1016/j.ijrobp.2011.05.002. Epub 2011 Aug 11.
PubMed 21840137
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT01097252
- Acronym / sponsor ID
- KCCH GY 1005
- Conditions
- Cervical Cancers
- Keywords
- Cervical Neoplasm, chemoradiation, compliance, toxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Korea Cancer Center HospitalUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Apr 2010 (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.
Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.
Detailed description
This study is to compare the compliance, toxicity, response and survival rate between concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in patients with advanced cervical cancer. Patients with primary untreated invasive squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA were enrolled. Patients with histologically proven locoregionally advanced cervical cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weekly cisplatin | Active comparator | Radiation: radiation, Drug: weekly cisplatinWeekly cisplatin 40mg/m2 during radiation therapy |
| tri-weekly cisplatin | Experimental | Radiation: radiation, Drug: tri-weekly cisplatincisplatin 75mg/m2 three cycles, every 3 weeks |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven cervical cancer
- Squamous, Adenosquamous, Adeno carcinoma cell type
- International Federation of Gynecologic Oncology (FIGO) stage IIB - IVA
- Gynecologic Oncology Group (GOG) performance status 0 - 2
Key exclusion criteria (5 listed)
- Previous history of chemotherapy or radiation
- History of other cancer
- Hypersensitivity to platinum agents
- Pregnancy
- Serious medical disease
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 |
|---|---|---|
| radiationradiation with cisplatin 40mg/m2, 6 cycles, every week | Radiation | tri-weekly cisplatin, weekly cisplatin |
| weekly cisplatinAlso: Cisplatinweekly cisplatin 40mg/m2, 6 cycles | Drug | weekly cisplatin |
| tri-weekly cisplatinAlso: Cisplatincisplatin 75mg/m2, 3cycles, every 3 weeks | Drug | tri-weekly cisplatin |
Primary outcome
compliance
Time frame: 3 month
1. Percentage of completed cycles of scheduled chemotherapy in each arm 2. Percentage of grade III and IV toxicity 3. Delayed radiation time due to toxicity
1 secondary outcome
survival
Time frame: 5 years
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 9 May 2014.
- Results publication: PubMed 21840137Ryu SY, Lee WM, Kim K, Park SI, Kim BJ, Kim MH, Choi SC, Cho CK, Nam BH, Lee ED. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e577-81. doi: 10.1016/j.ijrobp.2011.05.002. Epub 2011 Aug 11.
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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, MD principal investigator
Korea Institute of Radiological & Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation, weekly cisplatin and tri-weekly cisplatin in people with Cervical Cancers, 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 4 inclusion and 5 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 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
compliance (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097252, which also lists 1 linked publication.
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 9 May 2014.