Advanced Ovarian CancerPhase 2NCT01462149
Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer
A Phase 2 study testing Neoadjuvant chemotherapy and Carboplatin in people with Advanced Ovarian Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Advanced Ovarian Cancer
- What is being tested?
- Neoadjuvant chemotherapy and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Jun 2016
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced epithelial, tubal, or primary peritoneal cancer
- Cancer cells in paracentesis, thoracentesis, or laparoscopic surgery
- Less probability of complete cytoreduction
- Age: 20-80 years
- GOG performance status: 0-3
- Adequate organ function Bone marrow: ANC ≥ 1,500mm3, Platelet ≥ 100,000/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine ≤ 1.25 × UNL Liver: AST, ALT ≤ × 2.5 UNL (in case of liver metastasis, AST, ALT ≤ × 5 UNL), alkaline phosphatase ≤ 5 x UNL, bilirubin ≤ 1.5 mg/ mm3
Who cannot join
- Previous chemotherapy or pelvic radiation therapy
- Final diagnosis is other malignancies
- Coincidental Other malignancies within 5 years except carcinoma in situ of uterine cervix
- History of severe allergy
- Pregnancy, lactating woman
- Uncontrolled medial disease
- Bowel obstruction requiring immediate surgery
- Etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer
Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.
- Conditions
- Advanced Ovarian Cancer
- Being tested
- Neoadjuvant chemotherapy, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapyDrug
Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles
CarboplatinDrug
Carboplatin AUC 5, q 3 weeks, 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Neoadjuvant chemotherapy with docetaxel plus carboplatin Receives: Drug: Neoadjuvant chemotherapy; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 1 month after completion of study treatment
Secondary outcomes (4)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Before each chemotherapy, an average of 3 week
Disease-free survival
Measured: 2 years after completion of study treatment
Overall survival
Measured: 2 years after completion of study treatment
The number of participants who achieved optimal cytoreduction
Measured: 1 month after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Jong-Hyeok Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462149
- Sponsor's protocol ID
- NEODOCA-OVCA
- Status last verified
- May 2017
- First submitted
- 25 Oct 2011
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01462149
- Acronym / sponsor ID
- NEODOCA-OVCA
- Conditions
- Advanced Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Oct 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 Oct 2011 (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.
Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Neoadjuvant chemotherapy, Drug: CarboplatinNeoadjuvant chemotherapy with docetaxel plus carboplatin |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Advanced epithelial, tubal, or primary peritoneal cancer
- Cancer cells in paracentesis, thoracentesis, or laparoscopic surgery
- Less probability of complete cytoreduction
- Age: 20-80 years
- GOG performance status: 0-3
Key exclusion criteria (8 listed)
- Previous chemotherapy or pelvic radiation therapy
- Final diagnosis is other malignancies
- Coincidental Other malignancies within 5 years except carcinoma in situ of uterine cervix
- History of severe allergy
- Pregnancy, lactating woman
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 |
|---|---|---|
| Neoadjuvant chemotherapyDocetaxel 75mg/m2BAS, q 3 weeks, 3 cycles | Drug | Chemotherapy |
| CarboplatinCarboplatin AUC 5, q 3 weeks, 3 cycles | Drug | Chemotherapy |
Primary outcome
Response rate
Time frame: 1 month after completion of study treatment
4 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Before each chemotherapy, an average of 3 week
Disease-free survival
Time frame: 2 years after completion of study treatment
Overall survival
Time frame: 2 years after completion of study treatment
The number of participants who achieved optimal cytoreduction
Time frame: 1 month after completion of study treatment
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 31 May 2017.
Related trials for Advanced Ovarian Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant chemotherapy and Carboplatin in people with Advanced Ovarian Cancer, run by Asan Medical Center at 1 site in South Korea.
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 6 inclusion and 8 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 31 May 2017. 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 South Korea. 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 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?
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?
Response rate (time frame: 1 month after completion of study treatment). 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 31 May 2017.