Ovarian CancerISOTOVENCT02667925
Study of the Isotopic Distribution of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin
A study testing Intraperitoneal cisplatin with nanocis in people with Ovarian Cancer, run by Centre Jean Perrin at 1 site in France.
Trial summary
The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on platinum salt and surgery whose quality is the major prognostic factor. A meta-analysis of retrospective series had shown that for every 10% increase in the complete cytoreduction rates were increased by 5.5% overall survival… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Intraperitoneal cisplatin with nanocis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Sep 2016
- Phase
- Interventional
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance Status 0-2
- PNN> 1.5.109 / L (without added GCSF)
- Plaquettes> 100. 109 / L
- Bilirubine inferior or equal to 1.5 times the upper normal value (VNS)
- ASAT And ALT inferior or equal to 2.5 upper normal value (VNS)
- Alkaline Phosphatase inferior or equal to2.5 upper normal value (VNS)
Show all 14Show fewer
- Clairance Creatinine> 60ml / min Normal -Ionogramme
- PTT <1.5 times the upper normal value (VNS) (heparin, or other accepted lovenox anticoagulants)
- PT / INR inferior or equal to 1.5 upper normal value (VNS) (or INR between 2 and 3, if the patient receives a stabilized dose of Warfarin)
- Patient operated first line without macroscopic residual for ovarian cancer or primary peritoneal or tubal stage IIIC or IV peritoneal pleural
- Minimum Required for surgery: hysterectomy, oophorectomy, pelvic lymphadenectomy and para-aortic omentectomy
- Patient requiring adjuvant chemotherapy
- Compulsory affiliation to a social security scheme.
- Obtaining informed consent in writing, signed and dated.
Who cannot join
- Patient with cognitive and psychiatric disorders.
- Patient deprived of liberty by a court or administrative.
- Patient having directions against the achievement of chemotherapy
- Concomitant treatment with a drug test, participation in another therapeutic clinical trial within 30 days
- Pregnant women
- Nursing women
Show all 25Show fewer
- Patient with recognized hypersensitivity to cisplatin or platinum-containing products
- Patient with hypersensitivity recognized paclitaxel or any of the excipients
- Patient must be vaccinated against yellow fever
- Patient before taking phenytoin for prophylactic purposes
- Patient with hearing impairment
- Patient with hepatic impairment
- Patient with renal impairment Sensory or motor -Neuropathies> grade 1 (CTCAE)
- Hépatite Or severe infection requiring parenteral antibiotics
- Serious non-healing wound or ulcer, or bone fracture
- Fistule Abdominal or gastrointestinal perforation, or intra-abdominal abscess in the 28 days preceding the intraperitoneal chemotherapy Clinical -Symptômes, gastrointestinal obstruction or signs and / or which require a hydration and / or parenteral nutrition
- Patientes Has had or currently with inflammatory bowel disease
- Active bleeding or medical condition that carries a high risk of bleeding (eg, known coagulation disorders, coagulopathy, or tumor with large vessels)
- Cerebrovascular accident (CVA) or transient ischemic attack, or subarachnoid hemorrhage in the last 6 months
- Disease clinically significant cardiovascular, including:
- uncontrolled hypertension, defined as systolic blood pressure> 150mmHg or diastolic> 90mmHg
- myocardial infarction or unstable angina within the last 6 months
- NYHA class II-IV congestive heart failure
- serious cardiac arrhythmia requiring treatment: -an asymptomatic atrial fibrillation with controlled ventricular rate supraventricular tachycardia or controlled with medication and is authorized asymptomatic peripheral vascular disease o ≥ Grade 2 (CTCAE) (brief [less than 24 hours] ischemia episodes managed non-surgically and without permanent deficit)
- Antecedents of Hemorrhage or stroke (stroke), transient ischemic attack, or subarachnoid in the last 6 months Major Surgery within 28 days prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Isotopic Distribution of Intraperitoneal Postoperative Locoregional Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin
The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on platinum salt and surgery whose quality is the major prognostic factor.
A meta-analysis of retrospective series had shown that for every 10% increase in the complete cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001). Currently, it is recognized that the best chance of survival conferred to patients whose initial surgical residue is zero (Harter et al, 2009).
Read more
However, even if macroscopically complete surgery and whatever the type of systemic chemotherapy, peritoneal recurrence remains high for more than 75%.
To reducing it of recurrence, a therapeutic approach is to administer chemotherapy intraperitoneally.
The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal cavity.
Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of an intraperitoneal chemotherapy according to this method with a conventional systemic chemotherapy. Alberts reported a significant improvement in the median overall survival. Armstrong shows in addition a decreased risk of recurrence.
It must be remembered that:
- The establishment of an intra-abdominal catheter does not always ensure complete flow of drugs into the peritoneal cavity (major postoperative adhesions).
- There may be problems of catheters becoming blocked and requiring local treatment; these problems can cause abdominal pain whose care is difficult. Thus almost half of patients fail to get all six courses of intraperitoneal chemotherapy.
Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003, Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal pain sites described by the patient as well as peritoneal recurrence sites found during monitoring.
Read the detailed description
Epithelial ovarian cancer is the fifth leading cause of female cancer and the leading cause of death among gynecological cancers (Alberts et al, 2002). The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on platinum salt and surgery whose quality is the major prognostic factor.
A meta-analysis of retrospective series had shown that for every 10% increase in the complete cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001). Currently, it is recognized that the best chance of survival conferred to patients whose initial surgical residue is zero (Harter et al, 2009).
However, even if macroscopically complete surgery and whatever the type of systemic chemotherapy, peritoneal recurrence remains high for more than 75%.
To reducing it of recurrence, a therapeutic approach is to administer chemotherapy intraperitoneally.
The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal cavity at a frequency that is related to systemic chemotherapy (every 3 weeks).
Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of an intraperitoneal chemotherapy according to this method with a conventional systemic chemotherapy. Alberts reported a significant improvement in the median overall survival (49 vs 41 months). Armstrong shows in addition a decreased risk of recurrence.
It must be remembered that:
- The establishment of an intra-abdominal catheter does not always ensure complete flow of drugs into the peritoneal cavity (major postoperative adhesions).
- There may be problems of catheters becoming blocked and requiring local treatment; these problems can cause abdominal pain whose care is difficult. Thus almost half of patients fail to get all six courses of intraperitoneal chemotherapy.
Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003, Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal pain sites described by the patient as well as peritoneal recurrence sites found during monitoring.
- Conditions
- Ovarian Cancer
- Being tested
- Intraperitoneal cisplatin with nanocis
- Keywords
- ovarian cancer, intraperitoneal chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal cisplatin with nanocisDrug
Patients will receive an intraperitoneal chemotherapy combined to a radiotracer in order to assess the intraperitoneal distribution of the chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Patients will receive an intraperitoneal chemotherapy (cisplatin) combined to a radiotracer (nanocis) in order to assess the intraperitoneal distribution of the chemotherapy Receives: Drug: Intraperitoneal cisplatin with nanocis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification by visual analysis the intensity of fixation of the solvent characterized in the intraperitoneal cavity
The intensity of fixation will be defined as followed:
0: no fixation
- fixation of low intensity
- fixation of high intensity
Measured: During the 6 cycles of chemotherapy, that is during 18 weeks
Secondary outcomes (4)
Note adverse events assessed with CTCAE v4.0
The treatment-related adverse events will be assessed with CTCAE v4.0
Measured: During the 6 cycles of chemotherapy, that is during 18 weeks
Correlate pain intensity to fixation intensity in the peritoneal cavity
Pain intensity will be measured with EVA scale
Measured: During the 6 cycles of chemotherapy, that is during 18 weeks
dosimetric study with peritoneal scintigraphy
This study will be realised only for the first three patients included in the trial
Measured: During the 6 cycles of chemotherapy, that is during 18 weeks
Correlate site of relapse to localisation of labeled intraperitoneal solvent by nanocis in peritoneal cavity
Measured: During 5 years after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Because of the obsolescence of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Pomel, MD, PhD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667925
- Sponsor's protocol ID
- 2012-004103-12
- Acronym
- ISOTOVE
- Status last verified
- Sep 2016
- First submitted
- 19 Jan 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Harter P, Hilpert F, Mahner S, Kommoss S, Heitz F, Pfisterer J, du Bois A. Prognostic factors for complete debulking in first- and second-line ovarian cancer. Int J Gynecol Cancer. 2009 Dec;19 Suppl 2:S14-7. doi: 10.1111/IGC.0b013e3181bffb3f.
PubMed 19955907de Forni M, Boneu A, Otal P, Martel P, Shubinski R, Bugat R, Lucot H. Anatomic changes in the abdominal cavity during intraperitoneal chemotherapy: prospective study using scintigraphic peritoneography. Bull Cancer. 1993 Apr;80(4):345-50.
PubMed 8173187Varia MA, Stehman FB, Bundy BN, Benda JA, Clarke-Pearson DL, Alvarez RD, Long HJ; Gynecologic Oncology Group. Intraperitoneal radioactive phosphorus (32P) versus observation after negative second-look laparotomy for stage III ovarian carcinoma: a randomized trial of the Gynecologic Oncology Group. J Clin Oncol. 2003 Aug 1;21(15):2849-55. doi: 10.1200/JCO.2003.11.018.
PubMed 12885800Young RC, Brady MF, Nieberg RK, Long HJ, Mayer AR, Lentz SS, Hurteau J, Alberts DS. Adjuvant treatment for early ovarian cancer: a randomized phase III trial of intraperitoneal 32P or intravenous cyclophosphamide and cisplatin--a gynecologic oncology group study. J Clin Oncol. 2003 Dec 1;21(23):4350-5. doi: 10.1200/JCO.2003.02.154.
PubMed 14645424Dawson SJ, Hicks RJ, Johnston V, Allen D, Jobling T, Quinn M, Rischin D. Intraperitoneal distribution imaging in ovarian cancer patients. Intern Med J. 2011 Feb;41(2):167-71. doi: 10.1111/j.1445-5994.2009.02112.x.
PubMed 19849742Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5. doi: 10.1056/NEJM199612263352603.
PubMed 8960474Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
PubMed 16394300
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Isotopic Distribution of Intraperitoneal Postoperative Locoregional Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin
- ClinicalTrials.gov ID
- NCT02667925
- Acronym / sponsor ID
- ISOTOVE / 2012-004103-12
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, intraperitoneal chemotherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of the obsolescence of the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Jan 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.
The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on platinum salt and surgery whose quality is the major prognostic factor.
A meta-analysis of retrospective series had shown that for every 10% increase in the complete cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001). Currently, it is recognized that the best chance of survival conferred to patients whose initial surgical residue is zero (Harter et al, 2009).
However, even if macroscopically complete surgery and whatever the type of systemic chemotherapy, peritoneal recurrence remains high for more than 75%.
To reducing it of recurrence, a therapeutic approach is to administer chemotherapy intraperitoneally.
The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal cavity.
Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of an intraperitoneal chemotherapy according to this method with a conventional systemic chemotherapy. Alberts reported a significant improvement in the median overall survival. Armstrong shows in addition a decreased risk of recurrence.
It must be remembered that:
- The establishment of an intra-abdominal catheter does not always ensure complete flow of drugs into the peritoneal cavity (major postoperative adhesions).
- There may be problems of catheters becoming blocked and requiring local treatment; these problems can cause abdominal pain whose care is difficult. Thus almost half of patients fail to get all six courses of intraperitoneal chemotherapy.
Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003, Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal pain sites described by the patient as well as peritoneal recurrence sites found during monitoring.
Detailed description
Epithelial ovarian cancer is the fifth leading cause of female cancer and the leading cause of death among gynecological cancers (Alberts et al, 2002). The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on platinum salt and surgery whose quality is the major prognostic factor.
A meta-analysis of retrospective series had shown that for every 10% increase in the complete cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001). Currently, it is recognized that the best chance of survival conferred to patients whose initial surgical residue is zero (Harter et al, 2009).
However, even if macroscopically complete surgery and whatever the type of systemic chemotherapy, peritoneal recurrence remains high for more than 75%.
To reducing it of recurrence, a therapeutic approach is to administer chemotherapy intraperitoneally.
The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal cavity at a frequency that is related to systemic chemotherapy (every 3 weeks).
Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of an intraperitoneal chemotherapy according to this method with a conventional systemic chemotherapy. Alberts reported a significant improvement in the median overall survival (49 vs 41 months). Armstrong shows in addition a decreased risk of recurrence.
It must be remembered that:
- The establishment of an intra-abdominal catheter does not always ensure complete flow of drugs into the peritoneal cavity (major postoperative adhesions).
- There may be problems of catheters becoming blocked and requiring local treatment; these problems can cause abdominal pain whose care is difficult. Thus almost half of patients fail to get all six courses of intraperitoneal chemotherapy.
Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003, Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal pain sites described by the patient as well as peritoneal recurrence sites found during monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: Intraperitoneal cisplatin with nanocisPatients will receive an intraperitoneal chemotherapy (cisplatin) combined to a radiotracer (nanocis) in order to assess the intraperitoneal distribution of the chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Performance Status 0-2
- PNN> 1.5.109 / L (without added GCSF)
- Plaquettes> 100. 109 / L
- Bilirubine inferior or equal to 1.5 times the upper normal value (VNS)
- ASAT And ALT inferior or equal to 2.5 upper normal value (VNS)
Key exclusion criteria (25 listed)
- Patient with cognitive and psychiatric disorders.
- Patient deprived of liberty by a court or administrative.
- Patient having directions against the achievement of chemotherapy
- Concomitant treatment with a drug test, participation in another therapeutic clinical trial within 30 days
- Pregnant women
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 |
|---|---|---|
| Intraperitoneal cisplatin with nanocisPatients will receive an intraperitoneal chemotherapy combined to a radiotracer in order to assess the intraperitoneal distribution of the chemotherapy | Drug | Intervention arm |
Primary outcome
Quantification by visual analysis the intensity of fixation of the solvent characterized in the intraperitoneal cavity
Time frame: During the 6 cycles of chemotherapy, that is during 18 weeks
The intensity of fixation will be defined as followed: 0: no fixation 1. fixation of low intensity 2. fixation of high intensity
4 secondary outcomes
Note adverse events assessed with CTCAE v4.0
Time frame: During the 6 cycles of chemotherapy, that is during 18 weeks
Correlate pain intensity to fixation intensity in the peritoneal cavity
Time frame: During the 6 cycles of chemotherapy, that is during 18 weeks
dosimetric study with peritoneal scintigraphy
Time frame: During the 6 cycles of chemotherapy, that is during 18 weeks
Correlate site of relapse to localisation of labeled intraperitoneal solvent by nanocis in peritoneal cavity
Time frame: During 5 years after chemotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Background: PubMed 19955907Harter P, Hilpert F, Mahner S, Kommoss S, Heitz F, Pfisterer J, du Bois A. Prognostic factors for complete debulking in first- and second-line ovarian cancer. Int J Gynecol Cancer. 2009 Dec;19 Suppl 2:S14-7. doi: 10.1111/IGC.0b013e3181bffb3f.
- Background: PubMed 8173187de Forni M, Boneu A, Otal P, Martel P, Shubinski R, Bugat R, Lucot H. Anatomic changes in the abdominal cavity during intraperitoneal chemotherapy: prospective study using scintigraphic peritoneography. Bull Cancer. 1993 Apr;80(4):345-50.
- Background: PubMed 12885800Varia MA, Stehman FB, Bundy BN, Benda JA, Clarke-Pearson DL, Alvarez RD, Long HJ; Gynecologic Oncology Group. Intraperitoneal radioactive phosphorus (32P) versus observation after negative second-look laparotomy for stage III ovarian carcinoma: a randomized trial of the Gynecologic Oncology Group. J Clin Oncol. 2003 Aug 1;21(15):2849-55. doi: 10.1200/JCO.2003.11.018.
- Background: PubMed 14645424Young RC, Brady MF, Nieberg RK, Long HJ, Mayer AR, Lentz SS, Hurteau J, Alberts DS. Adjuvant treatment for early ovarian cancer: a randomized phase III trial of intraperitoneal 32P or intravenous cyclophosphamide and cisplatin--a gynecologic oncology group study. J Clin Oncol. 2003 Dec 1;21(23):4350-5. doi: 10.1200/JCO.2003.02.154.
- Background: PubMed 19849742Dawson SJ, Hicks RJ, Johnston V, Allen D, Jobling T, Quinn M, Rischin D. Intraperitoneal distribution imaging in ovarian cancer patients. Intern Med J. 2011 Feb;41(2):167-71. doi: 10.1111/j.1445-5994.2009.02112.x.
- Background: PubMed 8960474Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5. doi: 10.1056/NEJM199612263352603.
- Background: PubMed 16394300Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
- 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.
Christophe Pomel, MD, PhD principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraperitoneal cisplatin with nanocis in people with Ovarian Cancer, run by Centre Jean Perrin at 1 site in France.
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 25 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: withdrawn, as of the sponsor's last update on 11 Oct 2016. 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 France. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quantification by visual analysis the intensity of fixation of the solvent characterized in the intraperitoneal cavity (time frame: During the 6 cycles of chemotherapy, that is during 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667925, which also lists 7 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 11 Oct 2016.