Cervical CancerPhase 3NCT01461772
Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer
A Phase 3 study testing Radiation therapy, Carboplatin and Cisplatin in people with Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. 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?
- Radiation therapy, Carboplatin and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to May 2014
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated, histologically confirmed cervical cancer
- One of following histologic types Squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
- Age: 20-75 years
- GOG performance status: 0-2
- Adequate organ function Bone marrow: WBC ≥ 3,000/mm3, ANC ≥ 1,500/mm3, Platelet ≥ 100X103/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine < 1.25 × UNL, Liver : AST, ALT < 3 × UNL, T- bilirubin < 1.5 mg/ mm3
- Contraception during study treatment
- Informed consent
Who cannot join
- Previous chemotherapy or pelvic radiation therapy
- Hormone therapy within 4 weeks
- Concomitant malignancy within 5 years except cured basal cell carcinoma of skin
- Uncontrolled medical disease
- Pregnant or lactating woman
- Etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Concurrent Chemoradiation Therapy With Weekly Cisplatin and Concurrent Chemoradiation Therapy With Weekly Carboplatin in Locally Advanced Cervical Cancer: Phase III Multicenter Prospective Randomized Controlled Trial
Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- Radiation therapy, Carboplatin, 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.
Radiation therapyRadiation
pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)
CarboplatinDrug
carboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36
CisplatinDrug
Cisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36
| Study group | Role | What they receive |
|---|---|---|
| CCRT weekly carboplatin | Experimental | Concurrent chemoradiation therapy with weekly carboplatin Receives: Radiation: Radiation therapy; Drug: Carboplatin |
| CCRT weekly cisplatin | Active comparator | Concurrent chemoradiation therapy with weekly cisplatin Receives: Radiation: Radiation therapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 3 months after completion of study treatment
Secondary outcomes (4)
Number of patients with adverse events as a measure of safety and tolerability
Measured: Before each chemotherapy, an average of 1 week
Disease-free survival
Measured: 2 years after completion of study treatment
Overall survival
Measured: 2 years after completion of study treatment
Quality of life
Measured: 3 months after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startDec 2009
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Because of very slow rate of enrollement
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Joo-Hyun Nam, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461772
- Sponsor's protocol ID
- CCRTCICA-CXCA
- Status last verified
- May 2017
- First submitted
- 26 Oct 2011
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
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
- Comparison of Concurrent Chemoradiation Therapy With Weekly Cisplatin and Concurrent Chemoradiation Therapy With Weekly Carboplatin in Locally Advanced Cervical Cancer: Phase III Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01461772
- Acronym / sponsor ID
- CCRTCICA-CXCA
- Conditions
- Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of very slow rate of enrollement
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Study start
- Dec 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Oct 2011 (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 therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCRT weekly carboplatin | Experimental | Radiation: Radiation therapy, Drug: CarboplatinConcurrent chemoradiation therapy with weekly carboplatin |
| CCRT weekly cisplatin | Active comparator | Radiation: Radiation therapy, Drug: CisplatinConcurrent chemoradiation therapy with weekly cisplatin |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Previously untreated, histologically confirmed cervical cancer
- One of following histologic types Squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
- Age: 20-75 years
- GOG performance status: 0-2
- Adequate organ function Bone marrow: WBC ≥ 3,000/mm3, ANC ≥ 1,500/mm3, Platelet ≥ 100X103/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine < 1.25 × UNL, Liver : AST, ALT < 3 × UNL, T- bilirubin < 1.5 mg/ mm3
Key exclusion criteria (6 listed)
- Previous chemotherapy or pelvic radiation therapy
- Hormone therapy within 4 weeks
- Concomitant malignancy within 5 years except cured basal cell carcinoma of skin
- Uncontrolled medical disease
- Pregnant or lactating woman
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 |
|---|---|---|
| Radiation therapypelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed) | Radiation | CCRT weekly carboplatin, CCRT weekly cisplatin |
| Carboplatincarboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36 | Drug | CCRT weekly carboplatin |
| CisplatinCisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36 | Drug | CCRT weekly cisplatin |
Primary outcome
Response rate
Time frame: 3 months after completion of study treatment
4 secondary outcomes
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Before each chemotherapy, an average of 1 week
Disease-free survival
Time frame: 2 years after completion of study treatment
Overall survival
Time frame: 2 years after completion of study treatment
Quality of life
Time frame: 3 months after completion of study treatment
Results and safety
The study was stopped early (reason given: Because of very slow rate of enrollement). 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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy, Carboplatin and Cisplatin 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 7 inclusion and 6 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: stopped early, 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.
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 was stopped early (reason given: Because of very slow rate of enrollement). Results are not available in the source record.
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?
Response rate (time frame: 3 months after completion of study 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.