Bulky Stage IIIC and IV Epithelial Ovarian CancerPhase 2AICENCT01669226

First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer

A Phase 2 study testing PEip (weekly) and TCiv and TCiv in people with Bulky Stage IIIC and IV Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Bulky Stage IIIC and IV Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
What is being tested?: PEip (weekly) and TCiv and TCiv
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 215 participants
Where: 7 sitesChina
Study dates: Apr 2009to Jul 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 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years to ≤ 75 years.
Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone
Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm
Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection.
ECOG performance 0-2.
No more than 3 cycles of chemotherapy prior to surgery.

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Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic: bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin < 2.0, SGPT less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance greater than 40 mL/min.
Comply with intraperitoneal chemotherapy and follow-up.
Written informed consent.

Who cannot join

Low-malignant potential ovarian tumor.
Laboratory testing insufficiency. Hemoglobin < 10 g/dL. Renal insufficiency with serum creatinine > 1.6.
Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3.
Active infection.
Clinically significant gastrointestinal abnormalities.
Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure.
Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Prior invasive malignancies within the last 5 years showing activity of disease.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200030
Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality
Fudan University Cancer Hospital
Shanghai, 200032
Suzhou Municipal Hospital
Suzhou, Jiangsu
Wuxi Cancer Hospital
Wuxi, Jiangsu

Other trials in China

About this study

Official title: A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)

The purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.

Read the detailed description

This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.

Conditions: Bulky Stage IIIC and IV Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Being tested: PEip (weekly) and TCiv, TCiv
Keywords: Ovarian Cancer, intraperitoneal chemotherapy
Medical subject headings: Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PEip (weekly) and TCivDrug
Also called platinum, VP 16, taxane
IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
TCivDrug
Also called taxane, platinum
IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5

Study groups in NCT01669226
Study group	Role	What they receive
Regimen B, PEip and TCiv therapy	Experimental	Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin Receives: Drug: PEip (weekly) and TCiv
Regimen A: Standard TCiv therapy	Active comparator	IV paclitaxel plus carboplatin or docetaxel plus carboplatin Receives: Drug: TCiv

What is being measured

The primary outcome is the main question the study is designed to answer.

12-month disease non-progression rate
Measured: 12 months

Secondary outcomes (5)

Progression-free survival
Measured: up to 120 months
Completion rate of intraperitoneal chemotherapy.
Measured: up to 6 months
Quality of life assessments
Measured: baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.
Overall Survival
Measured: up to 120 months
adverse effects
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jul 2016

First posted20 Aug 2012 (estimated)
Study startApr 2009
Primary completionSep 2015
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bulky Stage IIIC and IV Epithelial 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01669226
Sponsor's protocol ID: V01-2009-03
Other IDs: SGOG OV1
Acronym: AICE
Status last verified: Dec 2016
First submitted: 8 Aug 2012
Last updated: 19 Dec 2016
Results posted: No
Data monitoring committee: Yes

Publications

Shi T, Jiang R, Pu H, Yang H, Tu D, Dai Z, Cai Y, Zhang Y, Cheng X, Jia H, Tu R, Wang H, Tang J, Luan Y, Cai S, Zang R; SGOG-OV/AICE Investigators. Survival benefits of dose-dense early postoperative intraperitoneal chemotherapy in front-line therapy for advanced ovarian cancer: a randomised controlled study. Br J Cancer. 2019 Aug;121(5):425-428. doi: 10.1038/s41416-019-0543-1. Epub 2019 Aug 6.
PubMed 31383985

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
ClinicalTrials.gov ID: NCT01669226
Acronym / sponsor ID: AICE / V01-2009-03
Conditions: Bulky Stage IIIC and IV Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Keywords: Ovarian Cancer, intraperitoneal chemotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: Shanghai Gynecologic Oncology GroupOther government
Collaborators: Fudan University, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital
Study start: Apr 2009
Primary completion: Sep 2015 (actual)
Study completion: Jul 2016 (actual)
First posted: 20 Aug 2012 (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 purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Regimen B, PEip and TCiv therapy	Experimental	Drug: PEip (weekly) and TCivWeekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
Regimen A: Standard TCiv therapy	Active comparator	Drug: TCivIV paclitaxel plus carboplatin or docetaxel plus carboplatin

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age ≥18 years to ≤ 75 years.
Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone
Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm
Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection.
ECOG performance 0-2.

Key exclusion criteria (8 listed)

Low-malignant potential ovarian tumor.
Laboratory testing insufficiency. Hemoglobin < 10 g/dL. Renal insufficiency with serum creatinine > 1.6.
Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3.
Active infection.
Clinically significant gastrointestinal abnormalities.

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
PEip (weekly) and TCivAlso: platinum, VP 16, taxaneIP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5	Drug	Regimen B, PEip and TCiv therapy
TCivAlso: taxane, platinumIV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5	Drug	Regimen A: Standard TCiv therapy

Primary outcome

12-month disease non-progression rate
Time frame: 12 months

5 secondary outcomes

Progression-free survival
Time frame: up to 120 months
Completion rate of intraperitoneal chemotherapy.
Time frame: up to 6 months
Quality of life assessments
Time frame: baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.
Overall Survival
Time frame: up to 120 months
adverse effects
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

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 19 Dec 2016.
Derived from this study: PubMed 31383985Shi T, Jiang R, Pu H, Yang H, Tu D, Dai Z, Cai Y, Zhang Y, Cheng X, Jia H, Tu R, Wang H, Tang J, Luan Y, Cai S, Zang R; SGOG-OV/AICE Investigators. Survival benefits of dose-dense early postoperative intraperitoneal chemotherapy in front-line therapy for advanced ovarian cancer: a randomised controlled study. Br J Cancer. 2019 Aug;121(5):425-428. doi: 10.1038/s41416-019-0543-1. Epub 2019 Aug 6.
Shanghai Gynecologic Oncology GroupLink provided by the sponsor.

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.

Rongyu Zang, MD,PhD principal investigator

Shanghai Gynecologic Oncology Group

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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?

12-month disease non-progression rate (time frame: 12 months). 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 NCT01669226, which also lists 1 linked publication.

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 19 Dec 2016.