Locally Advanced Cervical CancerPhase 3NCT00548821
Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer
A Phase 3 study testing Cisplatin in people with Locally Advanced Cervical Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSingapore
- Study dates
- Start not givento not given
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage IB2-IVA , histological proven cervical carcinoma
- no previous diagnosis of carcinoma
- no prior history of chemotherapy or radiotherapy
- ECOG less than or equal to 2
- Above 21 years old
- medically fit for radical concurrent Cisplatin based chemotherapy and radiotherapy
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- Hemoglobin >10g/dL
- Adequate hematological, renal and hepatic function according to all of the following laboratory values:
- Absolute neutrophil count ≥ 1.5 ×109/l
- Platelets ≥ 100 ×109/l
- Serum creatinine ≤ 1.5 times upper limit of laboratory normal
- Total serum bilirubin ≤ 1.5 times upper limit of laboratory normal
- ASAT(AST) or ALAT(ALT) ≤ 2.5 times upper limit of laboratory normal
- Alkaline phosphatase of ≤ 2.5 times upper limit of laboratory normal
Who cannot join
- Age below 21
- Presence of known HIV infection, chronic hepatitis B or hepatitis C infection
- Psychological, familial, sociological, or geographical condition that would preclude study participation
- Prior (within the last 3 years) or simultaneous malignancies (other then cutaneous basal cell carcinoma or non-invasive tumors)
- Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic.
- Life expectancy < 6 months
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- Patients with insulin dependent diabetes
- Prior tumor-directed surgery
- Previous systemic chemotherapy or pelvic radiation therapy
- As radiation and cytotoxic agents are contraindicated in pregnancy, pregnant women are ineligible and those of childbearing potential should use contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer
The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer. The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | ARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy. Receives: Drug: Cisplatin |
| 1 | Experimental | ARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer.
Secondary outcomes (1)
The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Johann Tang, Principal investigator, NUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548821
- Sponsor's protocol ID
- Cervix Cancer Research
- Status last verified
- May 2008
- First submitted
- 23 Oct 2007
- Last updated
- 15 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT00548821
- Acronym / sponsor ID
- Cervix Cancer Research
- Conditions
- Locally Advanced Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- First posted
- 24 Oct 2007 (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 primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer. The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: CisplatinARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy. |
| 1 | Experimental | Drug: CisplatinARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- stage IB2-IVA , histological proven cervical carcinoma
- no previous diagnosis of carcinoma
- no prior history of chemotherapy or radiotherapy
- ECOG less than or equal to 2
- Above 21 years old
Key exclusion criteria (10 listed)
- Age below 21
- Presence of known HIV infection, chronic hepatitis B or hepatitis C infection
- Psychological, familial, sociological, or geographical condition that would preclude study participation
- Prior (within the last 3 years) or simultaneous malignancies (other then cutaneous basal cell carcinoma or non-invasive tumors)
- Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic.
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 |
|---|---|---|
| Cisplatin | Drug | 1, 2 |
Primary outcome
The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer.
1 secondary outcome
The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2008.
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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.
Johann Tang principal investigator
NUH
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 Cisplatin in people with Locally Advanced Cervical Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 14 inclusion and 10 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 15 May 2008. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johann Tang (677204870, Johann_Tang@mail.nhg.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer.. 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 15 May 2008; AzTrials last refreshed its copy on 31 Oct 2026.