Ovarian CancerPhase 3NCT02728622
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane
A Phase 3 study testing Tamoxifen and Chemotherapy in people with Ovarian Cancer and Peritoneal Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit.
Trial summary
A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer, Cancer of the Fallopian Tube
- What is being tested?
- Tamoxifen and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Jan 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with invasive epithelial ovarian, fallopian tube or peritoneal cancer, being resistant to treatment with platinum and a taxane, either given in combination or sequentially.
- Patients with clinical progression during or within 6 months after end of treatment for primary disease or relapse.
- Patients with stable disease after 6 courses of chemotherapy for primary disease or relapse if further treatment is indicated.
- Patients with doubling of s-CA 125 to at least 70 IU/Ml within 3 months after end of treatment for primary disease or relapse.
- Age must be at least 18 years.
- Performance status must be 0-2 (WHO/ECOG, appendix 1).
- Informed consent given according to ICH/EU GCP guidelines and local or national laws
Who cannot join
- Patients with symptomatic brain metastasis
- Bilirubin greater than 2 x UNL (upper normal limits), white blood cell count below 3.0 x 109/L, neutrophil count below 1.5 x 109/L, platelets count below 100 x 109/L.
- Active infection or other serious underlying medical condition which might prevent the patient from receiving treatment or to be followed.
- Pregnant, lactating, or child bearing potential patients without adequate contraception
- Previous treatment with Tamoxifen.
About this study
Official title: A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane
A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.
Read the detailed description
Patients with platinum-resistant invasive epithelial ovarian, fallopian tube or peritoneal cancer will be randomized 1:2 to either hormonal treatment with Tamoxifen 40 mg daily or chemotherapy of investigator's choice (weekly paclitaxel given as an 1 hour infusion of paclitaxel 80 mg/m2 or pegylated liposomal doxorubicin 40 mg/m2 given every 4 weeks).
- Being tested
- Tamoxifen, Chemotherapy
- Keywords
- ovarian cancer, platinum-resistant, endocrine treatment, chemotherapy, tamoxifen
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
endocrine treatment
ChemotherapyDrug
Also called paclitaxel, pegylated liposomal doxorubicin
Paclitaxel or pegylated liposomal doxorubicin
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Experimental | Tamoxifen 40 mg is given orally once daily until progression Receives: Drug: Tamoxifen |
| Chemotherapy | Active comparator | Paclitaxel 80 mg/m2 is given as an 1 hour infusion every 7 days or Caelyx 40 mg/m2 is given iv, first dose over 2 hours, later doses are infused over 1 hour, administered every 4 weeks or up to a maximum dose of 550 mg/m2. Until progression Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality-adjusted survival
Measured: through completion of study, on average 1 year
Secondary outcomes (2)
progression-free survival
time to progressive disease or death
Measured: through completion of study, on average 3 months
overall survival
time to death of any cause
Measured: through completion of study, on average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startMar 2002
- Primary completionJan 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar B Kristensen, Prof, Study chair, The Norwegian Radium Hospital, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728622
- Sponsor's protocol ID
- NSGO-OC-0101
- Status last verified
- Mar 2016
- First submitted
- 19 Mar 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane
- ClinicalTrials.gov ID
- NCT02728622
- Acronym / sponsor ID
- NSGO-OC-0101
- Keywords
- ovarian cancer, platinum-resistant, endocrine treatment, chemotherapy, tamoxifen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials UnitUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Apr 2016 (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.
A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.
Detailed description
Patients with platinum-resistant invasive epithelial ovarian, fallopian tube or peritoneal cancer will be randomized 1:2 to either hormonal treatment with Tamoxifen 40 mg daily or chemotherapy of investigator's choice (weekly paclitaxel given as an 1 hour infusion of paclitaxel 80 mg/m2 or pegylated liposomal doxorubicin 40 mg/m2 given every 4 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | Experimental | Drug: TamoxifenTamoxifen 40 mg is given orally once daily until progression |
| Chemotherapy | Active comparator | Drug: ChemotherapyPaclitaxel 80 mg/m2 is given as an 1 hour infusion every 7 days or Caelyx 40 mg/m2 is given iv, first dose over 2 hours, later doses are infused over 1 hour, administered every 4 weeks or up to a maximum dose of 550 mg/m2. Until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with invasive epithelial ovarian, fallopian tube or peritoneal cancer, being resistant to treatment with platinum and a taxane, either given in combination or sequentially.
- Patients with clinical progression during or within 6 months after end of treatment for primary disease or relapse.
- Patients with stable disease after 6 courses of chemotherapy for primary disease or relapse if further treatment is indicated.
- Patients with doubling of s-CA 125 to at least 70 IU/Ml within 3 months after end of treatment for primary disease or relapse.
- Age must be at least 18 years.
Key exclusion criteria (5 listed)
- Patients with symptomatic brain metastasis
- Bilirubin greater than 2 x UNL (upper normal limits), white blood cell count below 3.0 x 109/L, neutrophil count below 1.5 x 109/L, platelets count below 100 x 109/L.
- Active infection or other serious underlying medical condition which might prevent the patient from receiving treatment or to be followed.
- Pregnant, lactating, or child bearing potential patients without adequate contraception
- Previous treatment with Tamoxifen.
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 |
|---|---|---|
| Tamoxifenendocrine treatment | Drug | Tamoxifen |
| ChemotherapyAlso: paclitaxel, pegylated liposomal doxorubicinPaclitaxel or pegylated liposomal doxorubicin | Drug | Chemotherapy |
Primary outcome
Quality-adjusted survival
Time frame: through completion of study, on average 1 year
2 secondary outcomes
progression-free survival
Time frame: through completion of study, on average 3 months
overall survival
Time frame: through completion of study, on average 1 year
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 5 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Gunnar B Kristensen, Prof study chair
The Norwegian Radium Hospital, Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamoxifen and Chemotherapy in people with Ovarian Cancer and Peritoneal Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit.
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 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 5 Apr 2016. 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 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?
Quality-adjusted survival (time frame: through completion of study, on average 1 year). 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 5 Apr 2016.