Cervical CancerPhase 2NCT01594099
Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women
A Phase 2 study testing irradiation, Cisplatin and liposome paclitaxel in people with Cervical Cancer, run by Xi'an Jiaotong University.
Trial summary
The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced cervical cancer in elderly women. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- irradiation, Cisplatin and liposome paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Mar 2014
- 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 65 to 80 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically proven squamous carcinoma of cervix
- FIGO stageⅡB and ⅢB
- Over 65 years
- Do not receive other treatment
- Performance index ECOG grade 0 to 2
- Normal ECG
- Normal hematological parameters
- Normal renal and liver function tests
Who cannot join
- Concomitant disease which may adversely affect the outcome
- Poor nutritional status
- Medical or psychological condition precluding treatment
- Previous treatment
- Concurrent treatment for any cancer
About this study
Official title: Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer
The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced cervical cancer in elderly women.
Read the detailed description
Concurrent radiotherapy is the standard treatment of inoperable cervical cancer .Due to the physical conditions, elderly patients usually associated with medical complications, so generally just receive radiotherapy alone. Recently, some retrospective studies have shown that the impact of chemotherapy did not cause an increase in the complication rate among elderly patients as compared to younger patients with cervical cancer, and may improve the survival when concurrent with radiotherapy. Cisplatin and paclitaxel are two effective drug in treating cervical cancer, but whether they are safe enough for elderly when concurrent with radiotherapy, there are no clearly reports. In this study ,we replace the conventional dose chemotherapy with weekly cisplatin or lipsome paclitaxel , to compare the efficiency and safety of weekly cisplatin / liposome paclitaxel concurrent chemoradiotherapy and radiotherapy alone in the treatment of cervical cancer in elderly patients.
- Conditions
- Cervical Cancer
- Being tested
- irradiation, Cisplatin, liposome paclitaxel
- Keywords
- cervical cancer, elderly women, concurrent chemotherapy
- 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.
irradiationRadiation
Also called RT
EBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border：branching of abdominal aorta. Lower border: the inferior margin of obturator foramen.
Brachytherapy :Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy，α/β=10).
CisplatinDrug
Also called RT+C
EBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border：branching of abdominal aorta. Lower border: the inferior margin of obturator foramen.
Brachytherapy: Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy，α/β=10).
Chemotherapy: Cisplatin (20mg /week) will be carry out in the 2nd to 6th week during radiation therapy.
liposome paclitaxelDrug
Also called RT+Lp
EBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border：branching of abdominal aorta. Lower border: the inferior margin of obturator foramen.
Brachytherapy: Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy，α/β=10).
Chemotherapy: Liposome paclitaxel (40mg /m2/2weeks) will be carry out in the 2nd ,4th,6th week during radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy alone | Active comparator | Not described Receives: Radiation: irradiation |
| Radiotherapy plus cisplatin | Experimental | Not described Receives: Drug: Cisplatin |
| Radiotherapy plus liposome paclitaxel | Experimental | Not described Receives: Drug: liposome paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate: Complete response (CR)+ Partial response (PR) rates base on RECIST evaluation system.
Measured: 1 month after the treatment completed
Adverse Events
Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0
Measured: Participants will be followed from the treatment begin to 1 month after the treatment end.
Secondary outcomes (3)
Local Control Rate
Measured: Participants will be followed every year for the duration of 5 years
Tumor Free Survival Rate
Measured: From date of randomization until tumor recurrence or metastasis,assessed up to 5 years
Overall Survival Rate
Measured: From date of randomization until the date of death from any cause,assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013 (estimated)
- Study completionMar 2014 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zi, Xi'an Jiaotong University
- Investigators
- Chen M W, M.D, Study director, Affiliated Hospital of Medical College of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594099
- Sponsor's protocol ID
- GCR-02
- Status last verified
- May 2012
- First submitted
- 27 Mar 2012
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer
- ClinicalTrials.gov ID
- NCT01594099
- Acronym / sponsor ID
- GCR-02
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, elderly women, concurrent chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 8 May 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.
The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced cervical cancer in elderly women.
Detailed description
Concurrent radiotherapy is the standard treatment of inoperable cervical cancer .Due to the physical conditions, elderly patients usually associated with medical complications, so generally just receive radiotherapy alone. Recently, some retrospective studies have shown that the impact of chemotherapy did not cause an increase in the complication rate among elderly patients as compared to younger patients with cervical cancer, and may improve the survival when concurrent with radiotherapy. Cisplatin and paclitaxel are two effective drug in treating cervical cancer, but whether they are safe enough for elderly when concurrent with radiotherapy, there are no clearly reports. In this study ,we replace the conventional dose chemotherapy with weekly cisplatin or lipsome paclitaxel , to compare the efficiency and safety of weekly cisplatin / liposome paclitaxel concurrent chemoradiotherapy and radiotherapy alone in the treatment of cervical cancer in elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy alone | Active comparator | Radiation: irradiation |
| Radiotherapy plus cisplatin | Experimental | Drug: Cisplatin |
| Radiotherapy plus liposome paclitaxel | Experimental | Drug: liposome paclitaxel |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Histologically proven squamous carcinoma of cervix
- FIGO stageⅡB and ⅢB
- Over 65 years
- Do not receive other treatment
- Performance index ECOG grade 0 to 2
Key exclusion criteria (5 listed)
- Concomitant disease which may adversely affect the outcome
- Poor nutritional status
- Medical or psychological condition precluding treatment
- Previous treatment
- Concurrent treatment for any cancer
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 |
|---|---|---|
| irradiationAlso: RTEBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border：branching of abdominal aorta. Lower border: the inferior margin of obturator foramen. Brachytherapy :Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy，α/β=10). | Radiation | Radiotherapy alone |
| CisplatinAlso: RT+CEBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border：branching of abdominal aorta. Lower border: the inferior margin of obturator foramen. Brachytherapy: Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy，α/β=10). Chemotherapy: Cisplatin (20mg /week) will be carry out in the 2nd to 6th week during radiation therapy. | Drug | Radiotherapy plus cisplatin |
| liposome paclitaxelAlso: RT+LpEBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border：branching of abdominal aorta. Lower border: the inferior margin of obturator foramen. Brachytherapy: Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy，α/β=10). Chemotherapy: Liposome paclitaxel (40mg /m2/2weeks) will be carry out in the 2nd ,4th,6th week during radiation therapy. | Drug | Radiotherapy plus liposome paclitaxel |
Primary outcome
Objective Response Rate
Time frame: 1 month after the treatment completed
Objective Response Rate: Complete response (CR)+ Partial response (PR) rates base on RECIST evaluation system.
Adverse Events
Time frame: Participants will be followed from the treatment begin to 1 month after the treatment end.
Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0
3 secondary outcomes
Local Control Rate
Time frame: Participants will be followed every year for the duration of 5 years
Tumor Free Survival Rate
Time frame: From date of randomization until tumor recurrence or metastasis,assessed up to 5 years
Overall Survival Rate
Time frame: From date of randomization until the date of death from any cause,assessed up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
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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.
Chen M W, M.D study director
Affiliated Hospital of Medical College of Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irradiation, Cisplatin and liposome paclitaxel in people with Cervical Cancer, run by Xi'an Jiaotong University.
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 8 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: status not confirmed, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Objective Response Rate (time frame: 1 month after the treatment completed). The study lists 2 primary outcomes in all. 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 8 May 2012.