Gastric Cancer With Peritoneal Metastasis (PCI<12)Phase 1/2NCT02995850
A Phase Ib/II Study of Efficacy and Feasibility of Cytoreductive Surgery, Extensive Peritoneal Lavage, Hyperthermicintraperitoneal Chemotherapy and Post-operative Intraperitoneal Chemotherapy Combination in Gastric Cancer With Peritoneal Metastasis
A Phase 1/2 study testing CRS+HIPEC in people with Gastric Cancer With Peritoneal Metastasis (PCI<12), run by Yonsei University at 1 site in South Korea.
Trial summary
This is an open-label, non-randomized, single-center, phase Ib/II study, evaluating efficacy and feasibility of cytoreductive surgery(CRS), extensive peritoneal lavage, hyperthermic intraperitoneal chemotherapy(HIPEC) and post-operative intraperitoneal chemotherapy combination in gastric cancer with peritoneal… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer With Peritoneal Metastasis (PCI<12)
- What is being tested?
- CRS+HIPEC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2017to 5 May 2022
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age of 19 years or older and age of 75 years or younger.
- Histologically proven gastric or esophagogastric junction adenocarcinoma with peritoneal metastasis under diagnostic laparoscopy.
- Primary tumor measured as resectable in preoperative images.
- Performance status based on ECOG : 0~1
- No prior treatment (chemotherapy, radiotherapy, etc.)
- Adequate hepatic, renal, and hematologic function
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- ANC≥1,500/uL,
- hemoglobin≥9.0g/dL
- platelet≥100,000/uL
- total Bilirubin: ≤ 1.5 × upper normal limit
- Creatinine<1.5mg/dL
- AST/ALT, ALP ≤ 2.5 x upper normal limit
- Patients who can understand this study and sign the consent form.
Who cannot join
- Patient who has distant metastasis or para-aortic lymph node metastasis or retroperitoneal metastasis except peritoneal metastasis. (But the patient who has ovarian metastasis with resectable status can be enrolled.)
- Primary tumor cannot be resected because of direct invasion to other important organ. (But, if the invaded organ can be resected together, such as spleen, gallbladder, distal pancreas, and liver, the patient can be enrolled)
- HER2 positive patient
- Patient with active viral infection (for example, HIV, HBV, HCV, except stable status of HBV infection)
- Pregnant patient, or patient in breast-feeding, or who is planning pregnancy.
- Patients in exclusion criteria of TS-1, cisplatin, paclitaxel
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- Patients with a history of severe hypersensitivity to these drugs
- Patients with severe bone marrow depression
- patients who has severe hepatic, renal disorder
- patients who has hereditary problem or galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
- Patients who has important medical problem or infection
- Cerebrovascular accident(CVA) within 1 year
- Heart attack within 6 months, uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure(CHF), severe arrhythmia
- Major operation or injury within 28 days
- Severe and not recovered wound, ulcer, fracture
- Uncontrolled bleeding disease
- Recent active gastric infection
- Patient with another primary cancer within last 5 years
- Patient on medication which can interact with the drugs used in this study (fluoropyrimidine-group antineoplastic agents, flucytosine, phenytoin, etc)
- Patients with other systemic chemotherapy or radiotherapy
- Patients with psychiatric or neurologic disorder so that he or she cannot understand and sign the consent form.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Yonsei University College of Medicine
Seoul, 03722
About this study
This is an open-label, non-randomized, single-center, phase Ib/II study, evaluating efficacy and feasibility of cytoreductive surgery(CRS), extensive peritoneal lavage, hyperthermic intraperitoneal chemotherapy(HIPEC) and post-operative intraperitoneal chemotherapy combination in gastric cancer with peritoneal metastasis
Read the detailed description
Peritoneal metastases in gastric cancer are considered to indicate terminal disease due to poor prognosis because systemic chemotherapy is unlikely to accumulate in peritoneal nodules in cytotoxic concentrations. Cytoreductive surgery (CRS) along with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in select patients with limited peritoneal spread, resulting in a median overall survival (OS) of 8 to 14 months. It remains unclear, however, which regimen is best and who have benefits from CRS and HIPEC. Herein, we has conducting prospective phase Ib/II trial of CRC and HIPEC with intraperitoneal paclitaxel and cisplatin, and oral S-1 in gastric cancer with peritoneal metastasis.
- Being tested
- CRS+HIPEC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRS+HIPECDrug
- Ib
- Dose-escalation of intraperitoneal paclitaxel will follow a modified 3 + 3 dose escalation procedure.
- II ① CRS If PCI <12, CRS will be performed by gastrectomy with D2-lymphadenectomy and resection of any involved adjacent structures. If PCI≥12, instead of CRS, 3 times of IP paclitaxel +cisplatin and oral S-1 chemotherapy every 3 weeks, and then PCI <12, CRS will be done. ② Extensiveintraperitoneal lavage Peritoneal lavage after CRS will be done with 10 L before HIPEC. ③ HIPEC Following surgery HIPEC will be performed using CDDP (60 mg/m2) and PTX (P2RD mg/m2). IP chemotherapy will be performed. ④ Post-operative intraperitoneal chemotherapy Postoperative chemotherapy will be done 8 cycles of IP paclitaxel+ cisplatin and oral S-1 after 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| anti-cancer drug | Experimental | Not described Receives: Drug: CRS+HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ib: Maximum tolerate dose
Ib: To determine the MTD of orally administered S-1 + intraperitoneal paclitaxel +cisplatin in gastric cancer with peritoneal metastasis.
Measured: 3 months
II: Safety
II:To assess the safety and tolerability of CRS +HIPEC (Clavien-Dindo classification of surgical complication \& NCI-common terminology criteria for adverse events(CTC-AE) for chemotherapy]
Measured: 3 months
Secondary outcomes (3)
OS (overall survival)
the length of time from the patient signing the consent form until the patient is still alive
Measured: 12 months
PFS (Progression-free survival)
the length of time from the patient signing the consent form until the patient shows disease progression
Measured: 12 months
RR (response rate)
the proportion of complete response to partial response These will be estimated by the Kaplan-Meire method.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start22 Feb 2017
- Primary completion19 Apr 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer With Peritoneal Metastasis (PCI<12)Studies of the same condition, open and under way.
- More trials run by Yonsei 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995850
- Sponsor's protocol ID
- 4-2016-0252
- Status last verified
- Aug 2023
- First submitted
- 14 Dec 2016
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of Efficacy and Feasibility of Cytoreductive Surgery, Extensive Peritoneal Lavage, Hyperthermicintraperitoneal Chemotherapy and Post-operative Intraperitoneal Chemotherapy Combination in Gastric Cancer With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT02995850
- Acronym / sponsor ID
- 4-2016-0252
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 19 Dec 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.
This is an open-label, non-randomized, single-center, phase Ib/II study, evaluating efficacy and feasibility of cytoreductive surgery(CRS), extensive peritoneal lavage, hyperthermic intraperitoneal chemotherapy(HIPEC) and post-operative intraperitoneal chemotherapy combination in gastric cancer with peritoneal metastasis
Detailed description
Peritoneal metastases in gastric cancer are considered to indicate terminal disease due to poor prognosis because systemic chemotherapy is unlikely to accumulate in peritoneal nodules in cytotoxic concentrations. Cytoreductive surgery (CRS) along with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in select patients with limited peritoneal spread, resulting in a median overall survival (OS) of 8 to 14 months. It remains unclear, however, which regimen is best and who have benefits from CRS and HIPEC. Herein, we has conducting prospective phase Ib/II trial of CRC and HIPEC with intraperitoneal paclitaxel and cisplatin, and oral S-1 in gastric cancer with peritoneal metastasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-cancer drug | Experimental | Drug: CRS+HIPEC |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient age of 19 years or older and age of 75 years or younger.
- Histologically proven gastric or esophagogastric junction adenocarcinoma with peritoneal metastasis under diagnostic laparoscopy.
- Primary tumor measured as resectable in preoperative images.
- Performance status based on ECOG : 0~1
- No prior treatment (chemotherapy, radiotherapy, etc.)
Key exclusion criteria (21 listed)
- Patient who has distant metastasis or para-aortic lymph node metastasis or retroperitoneal metastasis except peritoneal metastasis. (But the patient who has ovarian metastasis with resectable status can be enrolled.)
- Primary tumor cannot be resected because of direct invasion to other important organ. (But, if the invaded organ can be resected together, such as spleen, gallbladder, distal pancreas, and liver, the patient can be enrolled)
- HER2 positive patient
- Patient with active viral infection (for example, HIV, HBV, HCV, except stable status of HBV infection)
- Pregnant patient, or patient in breast-feeding, or who is planning pregnancy.
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 |
|---|---|---|
| CRS+HIPEC1. Ib * Dose-escalation of intraperitoneal paclitaxel will follow a modified 3 + 3 dose escalation procedure. 2. II ① CRS If PCI <12, CRS will be performed by gastrectomy with D2-lymphadenectomy and resection of any involved adjacent structures. If PCI≥12, instead of CRS, 3 times of IP paclitaxel +cisplatin and oral S-1 chemotherapy every 3 weeks, and then PCI <12, CRS will be done. ② Extensiveintraperitoneal lavage Peritoneal lavage after CRS will be done with 10 L before HIPEC. ③ HIPEC Following surgery HIPEC will be performed using CDDP (60 mg/m2) and PTX (P2RD mg/m2). IP chemotherapy will be performed. ④ Post-operative intraperitoneal chemotherapy Postoperative chemotherapy will be done 8 cycles of IP paclitaxel+ cisplatin and oral S-1 after 4 weeks. | Drug | anti-cancer drug |
Primary outcome
Ib: Maximum tolerate dose
Time frame: 3 months
Ib: To determine the MTD of orally administered S-1 + intraperitoneal paclitaxel +cisplatin in gastric cancer with peritoneal metastasis.
II: Safety
Time frame: 3 months
II:To assess the safety and tolerability of CRS +HIPEC (Clavien-Dindo classification of surgical complication \& NCI-common terminology criteria for adverse events(CTC-AE) for chemotherapy]
3 secondary outcomes
OS (overall survival)
Time frame: 12 months
PFS (Progression-free survival)
Time frame: 12 months
RR (response rate)
Time frame: 12 months
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 8 Aug 2023.
- Individual participant dataSharing planned: Undecided
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 1/2 study testing CRS+HIPEC in people with Gastric Cancer With Peritoneal Metastasis (PCI<12), run by Yonsei University 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 13 inclusion and 21 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 8 Aug 2023. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Ib: Maximum tolerate dose (time frame: 3 months). The study lists 2 primary outcomes in all. 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 8 Aug 2023.