Gastric CancerPhase 3NCT03475615
A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites
A Phase 3 study testing Oxaliplatin, Paclitaxel and S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules) in people with Gastric Cancer and Stomach Neoplasms, run by Fudan University at 1 site in China.
Trial summary
This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Stomach Neoplasms
- What is being tested?
- Oxaliplatin, Paclitaxel and S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2018to 31 Dec 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
- malignant ascites(over pelvic cavity in CT scan and confirmed by cytology)
- an Eastern Cooperative Oncology Group performance status of 0 to 2
- adequate renal, hepatic, and hematologic function
Who cannot join
- previous chemotherapy or radiotherapy (unless in the adjuvant setting)
- uncontrolled cardiac disease, or other clinically significant, uncontrolled
- coexisting illness or previous or concurrent cancer
- HER2 positive and willing to use trastuzumab
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, 200032
xiaodong Zhu, M.D, 862164175590 ext. 1105, xddr001@163.com
xiaodong Zhu, M.D
About this study
Official title: A Randomized Study of the Effect of First-line Intraperitoneal Paclitaxel in Combination With SOX Versus SOX Alone in Gastric Cancer Patients With Malignant Ascites
This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites
- Conditions
- Gastric Cancer, Stomach Neoplasms
- Being tested
- Oxaliplatin, Paclitaxel, S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
130mg/m2, d1, q3w
PaclitaxelDrug
40mg/m2 ip，d1、8 ,q3w
S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)Drug
40mg/m2 Bid po，d1-14,q3w
| Study group | Role | What they receive |
|---|---|---|
| SOXP | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: Paclitaxel; Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules) |
| SOX | Active comparator | Not described Receives: Drug: Oxaliplatin; Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
the internal between the date of enrollment and the date of death or last follow-up.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start16 Mar 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475615
- Sponsor's protocol ID
- FDZL-SOXP
- Status last verified
- Mar 2018
- First submitted
- 16 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Effect of First-line Intraperitoneal Paclitaxel in Combination With SOX Versus SOX Alone in Gastric Cancer Patients With Malignant Ascites
- ClinicalTrials.gov ID
- NCT03475615
- Acronym / sponsor ID
- FDZL-SOXP
- Conditions
- Gastric Cancer, Stomach Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Mar 2018 (actual)
- 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.
This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOXP | Experimental | Drug: Oxaliplatin, Drug: Paclitaxel, Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules) |
| SOX | Active comparator | Drug: Oxaliplatin, Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
- malignant ascites(over pelvic cavity in CT scan and confirmed by cytology)
- an Eastern Cooperative Oncology Group performance status of 0 to 2
- adequate renal, hepatic, and hematologic function
Key exclusion criteria (4 listed)
- previous chemotherapy or radiotherapy (unless in the adjuvant setting)
- uncontrolled cardiac disease, or other clinically significant, uncontrolled
- coexisting illness or previous or concurrent cancer
- HER2 positive and willing to use trastuzumab
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 |
|---|---|---|
| Oxaliplatin130mg/m2, d1, q3w | Drug | SOX, SOXP |
| Paclitaxel40mg/m2 ip，d1、8 ,q3w | Drug | SOXP |
| S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)40mg/m2 Bid po，d1-14,q3w | Drug | SOX, SOXP |
Primary outcome
overall survival
Time frame: 10 months
the internal between the date of enrollment and the date of death or last follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- 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.
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 Oxaliplatin, Paclitaxel and S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules) in people with Gastric Cancer and Stomach Neoplasms, run by Fudan University at 1 site in China.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Mar 2018. 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhu Xiaodong, MD (86-21-64175590, xddr001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 10 months). 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 23 Mar 2018.