Ovarian CancerPhase 3NCT00003214
Chemosensitivity Testing to Assign Treatment for Patients With Stage III or Stage IV Ovarian Cancer
A Phase 3 study testing carboplatin, cisplatin and cyclophosphamide in people with Ovarian Cancer, run by Swiss Cancer Institute at 10 sites in Switzerland.
Trial summary
RATIONALE: Chemosensitizers may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. PURPOSE: Randomized phase III trial to study the effectiveness of chemosensitivity testing to assign treatment for patients with stage III or stage IV ovarian cancer who have undergone… Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- carboplatin, cisplatin and cyclophosphamide
- How many people
- 300 participants
- Where
- 10 sitesSwitzerland
- Study dates
- Jul 1996to Apr 2000
- 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 Up to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically/pathologically confirmed stage III and IV ovarian cancer Complete surgical staging and debulking including total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and biopsies of suspicious lesions (if feasible) required No low malignant potential histology without any invasive lesions in the peritoneum
PATIENT CHARACTERISTICS: Age: 80 and under Performance status: 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No disorder that would prevent the application of any protocol treatment
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Switzerland10 sites
Kantonspital Aarau
Aarau, 5001
Frauenspital, Basel
Basel, 4031
Office of Walter Weber-Stadelman
Basel, CH 4051
University Hospital
Basel, CH-4031
Inselspital, Bern
Bern, CH-3010
Hopital Cantonal Universitaire de Geneva
Geneva, CH-1211
Istituto Oncologico della Svizzera Italiana
Lugano, CH-6900
Burgerspital, Solothurn
Solothurn, 4500
City Hospital Triemli
Zurich, 8063
Klinik Hirslanden
Zurich, CH-8008
About this study
Official title: Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III)
RATIONALE: Chemosensitizers may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.
PURPOSE: Randomized phase III trial to study the effectiveness of chemosensitivity testing to assign treatment for patients with stage III or stage IV ovarian cancer who have undergone surgery.
Read the detailed description
OBJECTIVES: I. Determine whether the use of a chemosensitivity assay to assign treatment improves the time to progression and response rates of patients with stage III/IV ovarian cancer.
OUTLINE: This is a randomized study. Patients are stratified according to size of tumor after debulking surgery, stage, and Swiss Group for Clinical Cancer Research center where treatment is received. Within 14 days after patients undergo debulking surgery, they are randomized to one of two treatment arms. Arm I: Patients randomized to this arm receive one of six treatment regimens: Regimen A - cisplatin/cyclophosphamide Regimen B - cisplatin/cyclophosphamide/doxorubicin Regimen C - carboplatin Regimen D - carboplatin/cyclophosphamide Regimen E - cisplatin/paclitaxel Regimen F - carboplatin/paclitaxel Arm II: Patients who are randomized to this arm are assigned a treatment regimen based on a chemosensitivity assay of tumor specimens collected after debulking surgery. If no valid assay result is obtained, patients receive carboplatin/cyclophosphamide. Treatment is repeated every 3-4 weeks for a total of 6 courses. Up to 4 more courses may be administered if a partial response is demonstrated. Patients are followed every 3 months for the first 2 years and every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 300 patients will be accrued for this study over 6 years.
- Conditions
- Ovarian Cancer
- Being tested
- carboplatin, cisplatin, cyclophosphamide, doxorubicin hydrochloride, in vitro sensitivity-directed chemotherapy
- Keywords
- stage III ovarian epithelial cancer, stage IV 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
cyclophosphamideDrug
in vitro sensitivity-directed chemotherapyDrug
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2004 (estimated)
- Study startJul 1996
- Primary completionApr 2000
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- O.R. Kochli, MD, Study chair, Frauenspital, Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003214
- Sponsor's protocol ID
- SAKK 45/94
- Other IDs
- SWS-SAKK-45/94, EU-97036
- Status last verified
- May 2019
- First submitted
- 1 Nov 1999
- Last updated
- 15 May 2019
- Results posted
- No
Publications
Koechli OR, Delaloye JF, Maibach R, et al.: Ovarian carcinoma FIGO II and IV - results of a randomized multicenter feasibility study with the ATP cell viability chemosensitivity assay. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-1326, 1997.
Mariotta M, Perewusnyk G, Koechli OR, Little JB, von Knebel Doeberitz M, Mirimanoff RO, Rutz HP. Dexamethasone-induced enhancement of resistance to ionizing radiation and chemotherapeutic agents in human tumor cells. Strahlenther Onkol. 1999 Aug;175(8):392-6. doi: 10.1007/s000660050027.
PubMed 10481771
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III)
- ClinicalTrials.gov ID
- NCT00003214
- Acronym / sponsor ID
- SAKK 45/94
- Conditions
- Ovarian Cancer
- Keywords
- stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Jul 1996
- Primary completion
- Apr 2000 (actual)
- Study completion
- Apr 2000 (actual)
- First posted
- 2 Aug 2004 (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: Chemosensitizers may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.
PURPOSE: Randomized phase III trial to study the effectiveness of chemosensitivity testing to assign treatment for patients with stage III or stage IV ovarian cancer who have undergone surgery.
Detailed description
OBJECTIVES: I. Determine whether the use of a chemosensitivity assay to assign treatment improves the time to progression and response rates of patients with stage III/IV ovarian cancer.
OUTLINE: This is a randomized study. Patients are stratified according to size of tumor after debulking surgery, stage, and Swiss Group for Clinical Cancer Research center where treatment is received. Within 14 days after patients undergo debulking surgery, they are randomized to one of two treatment arms. Arm I: Patients randomized to this arm receive one of six treatment regimens: Regimen A - cisplatin/cyclophosphamide Regimen B - cisplatin/cyclophosphamide/doxorubicin Regimen C - carboplatin Regimen D - carboplatin/cyclophosphamide Regimen E - cisplatin/paclitaxel Regimen F - carboplatin/paclitaxel Arm II: Patients who are randomized to this arm are assigned a treatment regimen based on a chemosensitivity assay of tumor specimens collected after debulking surgery. If no valid assay result is obtained, patients receive carboplatin/cyclophosphamide. Treatment is repeated every 3-4 weeks for a total of 6 courses. Up to 4 more courses may be administered if a partial response is demonstrated. Patients are followed every 3 months for the first 2 years and every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 300 patients will be accrued for this study over 6 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| in vitro sensitivity-directed chemotherapy | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
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 15 May 2019.
- BackgroundKoechli OR, Delaloye JF, Maibach R, et al.: Ovarian carcinoma FIGO II and IV - results of a randomized multicenter feasibility study with the ATP cell viability chemosensitivity assay. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-1326, 1997.
- Results publication: PubMed 10481771Mariotta M, Perewusnyk G, Koechli OR, Little JB, von Knebel Doeberitz M, Mirimanoff RO, Rutz HP. Dexamethasone-induced enhancement of resistance to ionizing radiation and chemotherapeutic agents in human tumor cells. Strahlenther Onkol. 1999 Aug;175(8):392-6. doi: 10.1007/s000660050027.
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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.
O.R. Kochli, MD study chair
Frauenspital, Basel
10 sites 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 cyclophosphamide in people with Ovarian Cancer, run by Swiss Cancer Institute at 10 sites in Switzerland.
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: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003214, which also lists 2 linked publications.
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 2019.