Ovarian CancerPhase 3NCT00006356
Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer
A Phase 3 study testing carboplatin, cisplatin and conventional surgery in people with Ovarian Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Italy.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- carboplatin, cisplatin and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2000to Oct 2002
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed recurrent ovarian epithelial cancer after first line chemotherapy, unless clear evidence of clinically progressive disease
- Must have received prior first line chemotherapy consisting of at least 4 courses of either cisplatin or carboplatin
- At least 12 months since prior chemotherapy
- Measurable disease by clinical exam or diagnostic laparoscopy
- At least one lesion greater than 1 cm in diameter
- No leptomeningeal or brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.25 times upper limit of normal (ULN)
- SGPT less than 2 times ULN
Renal:
- Creatinine less than 1.6 mg/dL OR
- Creatinine clearance greater than 40 mL/min
Other:
- No peripheral neurotoxicity greater than grade 2
- No psychological, familial, sociological, or geographical condition that would preclude study
- No complete bowel obstruction
- No other malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No more than 1 prior regimen of chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase III Study for the Treatment of Recurrent Epithelial Ovarian Cancer: Chemotherapy Alone Versus Chemotherapy Followed by Secondary Cytoreductive Surgery in Patients With a Treatment-Free Interval of More Than 12 Months
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy with or without surgery in treating patients who have recurrent epithelial ovarian cancer.
Read the detailed description
OBJECTIVES:
- Compare survival and progression free survival in patients with ovarian epithelial cancer after receiving treatment with chemotherapy with or without secondary cytoreductive surgery.
- Determine the toxicity of these treatment regimens in these patients.
- Determine the complications related to surgical treatment in these patients.
- Compare the quality of life in these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage at initial diagnosis (early stage I-IIa vs advanced stage IIb-IV), length of interval from end of prior first line chemotherapy (1-2 years vs more than 2 years), response to first 3 courses of second line induction chemotherapy in this study (no change vs partial remission vs complete remission), number of measurable tumor lesions (1 vs more than 1), largest tumor size of recurrence (less than 5 cm vs 5 cm or more), and participating center.
Patients receive second line induction chemotherapy with either 3 courses of a 3-4 week regimen or 6 courses of a weekly regimen of platinum based (cisplatin or carboplatin) therapy. Patients with no change, partial remission, or complete remission are randomized to one of two treatment arms.
- Arm I: Patients undergo secondary cytoreductive surgery within 14 days of randomization. Within 8 weeks after the last preoperative chemotherapy course, patients continue platinum based chemotherapy every 3-4 weeks for at least 3 additional courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients continue platinum based chemotherapy for at least 3 additional courses as in arm I.
Quality of life is assessed at baseline; before the 4th or 6th course of chemotherapy or 1 week before surgery; after the 6th course of chemotherapy in the chemotherapy only arm OR before the 4th or 6th course of chemotherapy in the surgery arm; 2 months after chemotherapy or after the 6th course of chemotherapy in the surgery arm; and then every 6 months for up to 5 years.
Patients are followed every 3 months for 2 years, and then every 6 months for 3 years or until disease progression.
PROJECTED ACCRUAL: Approximately 700 patients will be accrued for this study within 5 years.
- Conditions
- Ovarian Cancer
- Being tested
- carboplatin, cisplatin, conventional surgery
- Keywords
- recurrent ovarian epithelial cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
cisplatinDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2000
- Primary completionOct 2002
Why it stopped: low accrual
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.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Giuseppe Favalli, MD, Study chair, Ospedale Sta. Maria Delle Croci
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006356
- Sponsor's protocol ID
- EORTC-55963
- Other IDs
- EORTC-55963
- Status last verified
- Sep 2012
- First submitted
- 4 Oct 2000
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study for the Treatment of Recurrent Epithelial Ovarian Cancer: Chemotherapy Alone Versus Chemotherapy Followed by Secondary Cytoreductive Surgery in Patients With a Treatment-Free Interval of More Than 12 Months
- ClinicalTrials.gov ID
- NCT00006356
- Acronym / sponsor ID
- EORTC-55963
- Conditions
- Ovarian Cancer
- Keywords
- recurrent ovarian epithelial cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 38 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Aug 2000
- Primary completion
- Oct 2002 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy with or without surgery in treating patients who have recurrent epithelial ovarian cancer.
Detailed description
OBJECTIVES:
- Compare survival and progression free survival in patients with ovarian epithelial cancer after receiving treatment with chemotherapy with or without secondary cytoreductive surgery.
- Determine the toxicity of these treatment regimens in these patients.
- Determine the complications related to surgical treatment in these patients.
- Compare the quality of life in these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage at initial diagnosis (early stage I-IIa vs advanced stage IIb-IV), length of interval from end of prior first line chemotherapy (1-2 years vs more than 2 years), response to first 3 courses of second line induction chemotherapy in this study (no change vs partial remission vs complete remission), number of measurable tumor lesions (1 vs more than 1), largest tumor size of recurrence (less than 5 cm vs 5 cm or more), and participating center.
Patients receive second line induction chemotherapy with either 3 courses of a 3-4 week regimen or 6 courses of a weekly regimen of platinum based (cisplatin or carboplatin) therapy. Patients with no change, partial remission, or complete remission are randomized to one of two treatment arms.
- Arm I: Patients undergo secondary cytoreductive surgery within 14 days of randomization. Within 8 weeks after the last preoperative chemotherapy course, patients continue platinum based chemotherapy every 3-4 weeks for at least 3 additional courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients continue platinum based chemotherapy for at least 3 additional courses as in arm I.
Quality of life is assessed at baseline; before the 4th or 6th course of chemotherapy or 1 week before surgery; after the 6th course of chemotherapy in the chemotherapy only arm OR before the 4th or 6th course of chemotherapy in the surgery arm; 2 months after chemotherapy or after the 6th course of chemotherapy in the surgery arm; and then every 6 months for up to 5 years.
Patients are followed every 3 months for 2 years, and then every 6 months for 3 years or until disease progression.
PROJECTED ACCRUAL: Approximately 700 patients will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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.
Giuseppe Favalli, MD study chair
Ospedale Sta. Maria Delle Croci
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 carboplatin, cisplatin and conventional surgery in people with Ovarian Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Sep 2012. 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 Italy. 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: low accrual). 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.
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 24 Sep 2012.