Stomach NeoplasmCy-plusNCT02969122
Treatment Strategy for Stage IV Gastric Cancer with Positive Peritoneal Cytology As the Only Non-curable Factor
A study testing standard gastrectomy with D2 lymphadenectomy, hyperthermic intraperitoneal chemotherapy and Extensive intraperitoneal lavage in people with Stomach Neoplasm, run by Peking University at 1 site in China.
Trial summary
Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging system. Controversy exists on the treatment of this part of patients. This trial aimed to explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal cytology as the only non-curable factor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- standard gastrectomy with D2 lymphadenectomy, hyperthermic intraperitoneal chemotherapy and Extensive intraperitoneal lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to 9 Sep 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathologically diagnosed gastric adenocarcinoma with endoscopic biopsy;
- Pretreatment clinical stage with computed tomography and/or endoscopic ultrasonography;
- Clinical stage cT2-4 N0-3 M0;
- Standard gastrectomy with D2 lymphadenectomy is needed according to the clinicians' evaluation;
- ECOG performance score ≤2, with tolerance of standard gastrectomy and D2 lymphadenectomy;
- Positive peritoneal cytology;
- Signed informed consent.
Who cannot join
- Remnant gastric cancer, recurrence gastric cancer or multi-primary cancers;
- Intraoperative identified other unresectable factors including other metastasis except positive peritoneal cytology;
- Postoperative pathologically diagnosed as non adenocarcinoma;
- Pregnant or lactate women;
- Child-bearing period adults who refuse to birth control during the trial;
- Uncontrolled epilepsy, CNS disease or mental disorder that may influence the compliance of the patient;
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- Severe/active heart disease, including but not limited to acute coronary syndrome, congestive heart failure with less than NYHA II cardiac function, severe arrhythmia that needs drug control, cardiac infarction within 12 month;
- Organ transplantation patients who needs immune suppression therapy;
- Patients who needs emergency surgery because of bleeding, perforation or obstruction.
Trial locations and contacts
1 site in 1 country.
China1 site
Gastrointestinal Cancer Center, Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: Treatment Strategy for Stage IV Gastric Cancer with Positive Peritoneal Cytology As the Only Non-curable Factor (Cy-plus): a Phase 2, Randomized Controlled Trial
Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging system. Controversy exists on the treatment of this part of patients. This trial aimed to explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal cytology as the only non-curable factor.
Read the detailed description
In the 7th AJCC/UICC TNM staging system, gastric cancer with positive peritoneal cytology (CY+) is defined as stage IV disease. In NCCN clinical practice guidelines, it is suggested that positive peritoneal cytology in the absence of visible peritoneal implants should be considered as M1 disease and surgery as initial treatment is not recommended for patients with positive peritoneal cytology. However, in the Japanese gastric cancer treatment guidelines 2014, it is suggested that standard gastrectomy can be proposed for patients with no other non-curative factors and if the CY+ status was revealed after surgery, postoperative treatment with S-1 can be recommended as the tentative standard. Previous studies have also proved that extensive intraperitoneal lavage(EIPL) and Hyperthermic Intraperitoneal Chemotherapy(HIPEC) are effective methods for the treatment of peritoneal metastasis.
In order to optimize the treatment strategy of this part of patients, this trial is designed to compare the effectiveness of 2 treatment strategies.
- Conditions
- Stomach Neoplasm
- Being tested
- standard gastrectomy with D2 lymphadenectomy, hyperthermic intraperitoneal chemotherapy, Extensive intraperitoneal lavage, Preoperative chemotherapy, Postoperative chemotherapy
- Keywords
- gastric cancer, peritoneal cytology
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard gastrectomy with D2 lymphadenectomyProcedure or surgery
standard distal or total gastrectomy and accorded D2 lymphadenectomy
hyperthermic intraperitoneal chemotherapyProcedure or surgery
Also called HIPEC
Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes
Extensive intraperitoneal lavageProcedure or surgery
Also called EIPL
Lavage of peritoneal cavity with 1000ml saline for 10 times
Preoperative chemotherapyOther
Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.
Postoperative chemotherapyOther
SOX regimen postoperative chemotherapy (Oxaliplatin 130mg/m2 D1, S-1 40-60mg Bid D1-14, Repeated every 3 weeks) for surgery-first arm. Regimen for chemotherapy-first arm is determined according to the postoperative pathologic evaluation of response.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy-first | Active comparator | Patients will receive hyperthermic intraperitoneal chemotherapy (HIPEC) during laparoscopic staging. Then 3 cycles of preoperative chemotherapy and clinical evaluation of chemotherapy will be performed. If the patient's disease is evaluated as progressed, the patient will receive systemic therapy. If it's stable or remission, a second time laparoscopic staging and peritoneal cytology examination will be performed. If peritoneal implant is observed, the patients will receive systemic therapy. If the peritoneal cytology is still positive, the treatment will be decided according to the suggestion of MDT discussion. If the peritoneal cytology is converted negative, standard gastrectomy with D2 lymphadenectomy and extensive intraperitoneal lavage (EIPL) will be performed. Postoperative chemotherapy will be determined according to the pathological evaluation of preoperative chemotherapy response. Receives: Procedure: standard gastrectomy with D2 lymphadenectomy; Procedure: hyperthermic intraperitoneal chemotherapy; Procedure: Extensive intraperitoneal lavage; Other: Preoperative chemotherapy; Other: Postoperative chemotherapy |
| Surgery-first | Experimental | Patients in this arm will receive standard gastrectomy with D2 lymphadenectomy after randomization. Hyperthermic intraperitoneal chemotherapy (HIPEC) and extensive intraperitoneal lavage (EIPL) will be applied before abdominal closure. After surgery, 8 cycles of postoperative chemotherapy will be performed. Receives: Procedure: standard gastrectomy with D2 lymphadenectomy; Procedure: hyperthermic intraperitoneal chemotherapy; Procedure: Extensive intraperitoneal lavage; Other: Postoperative chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 year
Secondary outcomes (4)
peritoneal recurrence rate
Measured: 3 year
Recurrence free survival
Measured: 3 year
rate of peritoneal cytology converted to negative
Measured: 7 days After the second time laparoscopic staging and peritoneal cytology examination
morbidity and mortality of HIPEC and EIPL
Measured: 30 days after HIPEC and EIPL procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Why it stopped: Not enough cases enrolled in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Peking 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiafu Ji, Peking University
- Investigators
- Jiafu Ji, M.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969122
- Sponsor's protocol ID
- 2016YJZ35
- Acronym
- Cy-plus
- Status last verified
- Sep 2024
- First submitted
- 12 Nov 2016
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategy for Stage IV Gastric Cancer with Positive Peritoneal Cytology As the Only Non-curable Factor (Cy-plus): a Phase 2, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02969122
- Acronym / sponsor ID
- Cy-plus / 2016YJZ35
- Conditions
- Stomach Neoplasm
- Keywords
- gastric cancer, peritoneal cytology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough cases enrolled in the study.
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 21 Nov 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.
Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging system. Controversy exists on the treatment of this part of patients. This trial aimed to explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal cytology as the only non-curable factor.
Detailed description
In the 7th AJCC/UICC TNM staging system, gastric cancer with positive peritoneal cytology (CY+) is defined as stage IV disease. In NCCN clinical practice guidelines, it is suggested that positive peritoneal cytology in the absence of visible peritoneal implants should be considered as M1 disease and surgery as initial treatment is not recommended for patients with positive peritoneal cytology. However, in the Japanese gastric cancer treatment guidelines 2014, it is suggested that standard gastrectomy can be proposed for patients with no other non-curative factors and if the CY+ status was revealed after surgery, postoperative treatment with S-1 can be recommended as the tentative standard. Previous studies have also proved that extensive intraperitoneal lavage(EIPL) and Hyperthermic Intraperitoneal Chemotherapy(HIPEC) are effective methods for the treatment of peritoneal metastasis.
In order to optimize the treatment strategy of this part of patients, this trial is designed to compare the effectiveness of 2 treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy-first | Active comparator | Procedure: standard gastrectomy with D2 lymphadenectomy, Procedure: hyperthermic intraperitoneal chemotherapy, Procedure: Extensive intraperitoneal lavage, Other: Preoperative chemotherapy, Other: Postoperative chemotherapyPatients will receive hyperthermic intraperitoneal chemotherapy (HIPEC) during laparoscopic staging. Then 3 cycles of preoperative chemotherapy and clinical evaluation of chemotherapy will be performed. If the patient's disease is evaluated as progressed, the patient will receive systemic therapy. If it's stable or remission, a second time laparoscopic staging and peritoneal cytology examination will be performed. If peritoneal implant is observed, the patients will receive systemic therapy. If the peritoneal cytology is still positive, the treatment will be decided according to the suggestion of MDT discussion. If the peritoneal cytology is converted negative, standard gastrectomy with D2 lymphadenectomy and extensive intraperitoneal lavage (EIPL) will be performed. Postoperative chemotherapy will be determined according to the pathological evaluation of preoperative chemotherapy response. |
| Surgery-first | Experimental | Procedure: standard gastrectomy with D2 lymphadenectomy, Procedure: hyperthermic intraperitoneal chemotherapy, Procedure: Extensive intraperitoneal lavage, Other: Postoperative chemotherapyPatients in this arm will receive standard gastrectomy with D2 lymphadenectomy after randomization. Hyperthermic intraperitoneal chemotherapy (HIPEC) and extensive intraperitoneal lavage (EIPL) will be applied before abdominal closure. After surgery, 8 cycles of postoperative chemotherapy will be performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically diagnosed gastric adenocarcinoma with endoscopic biopsy;
- Pretreatment clinical stage with computed tomography and/or endoscopic ultrasonography;
- Clinical stage cT2-4 N0-3 M0;
- Standard gastrectomy with D2 lymphadenectomy is needed according to the clinicians' evaluation;
- ECOG performance score ≤2, with tolerance of standard gastrectomy and D2 lymphadenectomy;
Key exclusion criteria (9 listed)
- Remnant gastric cancer, recurrence gastric cancer or multi-primary cancers;
- Intraoperative identified other unresectable factors including other metastasis except positive peritoneal cytology;
- Postoperative pathologically diagnosed as non adenocarcinoma;
- Pregnant or lactate women;
- Child-bearing period adults who refuse to birth control during the trial;
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 |
|---|---|---|
| standard gastrectomy with D2 lymphadenectomystandard distal or total gastrectomy and accorded D2 lymphadenectomy | Procedure or surgery | Chemotherapy-first, Surgery-first |
| hyperthermic intraperitoneal chemotherapyAlso: HIPECIntraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes | Procedure or surgery | Chemotherapy-first, Surgery-first |
| Extensive intraperitoneal lavageAlso: EIPLLavage of peritoneal cavity with 1000ml saline for 10 times | Procedure or surgery | Chemotherapy-first, Surgery-first |
| Preoperative chemotherapyOxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks. | Other | Chemotherapy-first |
| Postoperative chemotherapySOX regimen postoperative chemotherapy (Oxaliplatin 130mg/m2 D1, S-1 40-60mg Bid D1-14, Repeated every 3 weeks) for surgery-first arm. Regimen for chemotherapy-first arm is determined according to the postoperative pathologic evaluation of response. | Other | Chemotherapy-first, Surgery-first |
Primary outcome
Overall survival
Time frame: 3 year
4 secondary outcomes
peritoneal recurrence rate
Time frame: 3 year
Recurrence free survival
Time frame: 3 year
rate of peritoneal cytology converted to negative
Time frame: 7 days After the second time laparoscopic staging and peritoneal cytology examination
morbidity and mortality of HIPEC and EIPL
Time frame: 30 days after HIPEC and EIPL procedures
Results and safety
The study was stopped early (reason given: Not enough cases enrolled in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Jiafu Ji, M.D. principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard gastrectomy with D2 lymphadenectomy, hyperthermic intraperitoneal chemotherapy and Extensive intraperitoneal lavage in people with Stomach Neoplasm, run by Peking 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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.
Are results available for this study?
The study was stopped early (reason given: Not enough cases enrolled in the study.). Results are not available in the source record.
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?
Overall survival (time frame: 3 year). 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 19 Sep 2024.