Gastric AdenocarcinomaPhase 2Neo-ClassicNCT01880632
Oxaliplatin Plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma
A Phase 2 study testing XELOX in people with Gastric Adenocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
1. Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy. 2. Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- XELOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Aug 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented gastricadenocarcinoma with Lauren classification Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable
- Measurable disease is required
- Karnofsky score 80%.
- Physical condition and adequate organ function to ensure the success of abdominal surgery.
- Life expectancy ≥12 weeks.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥8g/dL .Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
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- Female subjects should not be pregnant or breast-feeding.
- No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- Male or female.
- Age ≥ 18 years and ≤75 years
- Written (signed) informed consent.
- Able to comply with study and follow-up procedures.
- Good compliance with the treatment plan.
- Consent to provide tissue sample.
Who cannot join
- Pregnant or lactating (in case of potentially childbearing woman, pregnancy test is positive)
- Patients of child-bearing age or the potential to father a child who refuse to use adequate contraception
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- History of another malignancy in the last 5 years with the exception of the following:
- Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy. Prior treatment for locally advanced or metastatic gastric cancer. Any metastatic disease will render patient ineligible according to AJCC staging manual.
- Distant metastases (M1) including distant nodal Groups (peripancreatic, para-aortic, portal, retroperitoneal, mesenteric node, by CT/MRI, or PET/CT
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- Treatment within the last 30 days with any investigational drug. Concurrent administration of any other cancer therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Poorly controlled diabetes mellitus with fasting blood sugar > 18 mM. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- History of significant neurological or mental disorder, including seizures or dementia, which would interfere compliance and sign of consent inform. any history of hypersensitivity to 5-fluorouracil or platinum and other investigational drug
- Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug reabsorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine, indications of reabsorption disorders after intestinal surgery
- Unstable, persistent cardiac disease despite medicinal treatment, myocardial infarction within 6 months before the start of the trial
- Organ transplant patient need immunosuppression treatment.
- Previous surgery on primary tumour; Prior palliative surgery (open and closure, passage operation)
- Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated
- Symptomatic peripheral neuropathy NCI CTC version> 3.0 grade.
- Patients under anticoagulant therapy with warfarin or other coumarines are excluded from participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, doctor, liu.tianshu@zs-hospital.sh.cn
Yiyi yu, Master
About this study
Official title: A Multicenter, Single Arm, Open-label Trial of Oxaliplatin Plus Capecitabine (XELOX) in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma
- Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy.
- Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC. Secondary objectives:
- The progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0);
- percentage of pathological response ; percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments;
- D2 resection -rate after neoadjuvant chemotherapy of XELOX;
- Overall survival;
- QOL during the whole period of treatment.
- Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative treatment of locally advanced gastric adenocarcinoma in combination with D2 resection.
- Treatment plan:Patients will be given the perioperative chemotherapy as below once recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ，bid,d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week)Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks.
- Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of gastric operations in China, more than 500 per year.
Read the detailed description
- Disease specific inclusion criteria:
- Histologically documented gastricadenocarcinoma with Lauren classification Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable
- Measurable disease is required
- Karnofsky score 80%.
- Physical condition and adequate organ function to ensure the success of abdominal surgery.
- Life expectancy ≥12 weeks.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥8g/dL .Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L. Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
- Female subjects should not be pregnant or breast-feeding.
- No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- General inclusion criteria:
- Male or female. Age ≥ 18 years and ≤75 years
- Written (signed) informed consent.
- Able to comply with study and follow-up procedures.
- Good compliance with the treatment plan。
- Consent to provide tissue sample。
- Conditions
- Gastric Adenocarcinoma
- Being tested
- XELOX
- Keywords
- XELOX, perioperative treatment, locally advanced gastric adenocarcinoma, D2 resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XELOXDrug
Patients will be given the perioperative chemotherapy as below once recruited:
Capecitabine ：500 mg tablets（Roche） Oxaliplatin：50mg/10ml（according to daily practice in each center）
Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow:
Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, bid ， d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week) Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| XELOX | Experimental | Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable Receives: Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
the response rate of XELOX in the neoadjuvant setting of LAGC
the response rate evaluation will be based on tumor assessment with follow-up, including chest and upper-abdominal During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after)., brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.
Measured: 6 months after the last subject participating in
Secondary outcomes (5)
the progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT2-3/N+M0,or cT4aN+M0)
progression by the evidence of CT/MRI scan at each evaluation at neoadjuvant period or follow-up time after surgery；During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after).After syrgery, CT scan will be planned every 6 months, brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.
Measured: 42 months after the last subject participating in
percentage of pathological response
After surgery，the pathological response will be measured by the pathologist for every Operation patient.
Measured: 10 months after the last subject participating in
Percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments
Adverse events and clinical laboratory tests will be recorded by CTCAE (version 4.0) during the whole treatment period.
Measured: 1 month after the last date of treatment
Overall survival
During the OS follow-up, out-patient clinic and telephone visit will be done every 3 months for the first two years, and every 6 months after two years.
Measured: 3 years after the last subject participating in
QOL during the whole period of treatment
These assessment will be evaluated at every evaluation.
Measured: 1 years after the last date of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2016 (estimated)
- Study completionAug 2018 (estimated)
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 Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University
- Responsible party
- Principal investigator, Tianshu Liu, Shanghai Zhongshan Hospital
- Investigators
- Tianshu Liu, Doctor, Principal investigator, Medical oncology Shanghai zhongshan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880632
- Sponsor's protocol ID
- ML28733
- Acronym
- Neo-Classic
- Status last verified
- Dec 2015
- First submitted
- 8 Jun 2013
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yu Y, Fang Y, Shen Z, Wang Y, Yan M, Cao H, Liu Y, Wang X, Cui Y, Liu F, Chen W, Li W, Li Q, Jiang H, Sun Y, Liu T. Oxaliplatin plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma in Combination with D2 Gastrectomy: NEO-CLASSIC Study. Oncologist. 2019 Oct;24(10):1311-e989. doi: 10.1634/theoncologist.2019-0416. Epub 2019 Jun 25.
PubMed 31239311
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Arm, Open-label Trial of Oxaliplatin Plus Capecitabine (XELOX) in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01880632
- Acronym / sponsor ID
- Neo-Classic / ML28733
- Conditions
- Gastric Adenocarcinoma
- Keywords
- XELOX, perioperative treatment, locally advanced gastric adenocarcinoma, D2 resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University
- Study start
- Jul 2013
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 Jun 2013 (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.
- Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy.
- Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC. Secondary objectives:
- The progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0);
- percentage of pathological response ; percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments;
- D2 resection -rate after neoadjuvant chemotherapy of XELOX;
- Overall survival;
- QOL during the whole period of treatment.
- Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative treatment of locally advanced gastric adenocarcinoma in combination with D2 resection.
- Treatment plan:Patients will be given the perioperative chemotherapy as below once recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ，bid,d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week)Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks.
- Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of gastric operations in China, more than 500 per year.
Detailed description
- Disease specific inclusion criteria:
- Histologically documented gastricadenocarcinoma with Lauren classification Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable
- Measurable disease is required
- Karnofsky score 80%.
- Physical condition and adequate organ function to ensure the success of abdominal surgery.
- Life expectancy ≥12 weeks.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥8g/dL .Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L. Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
- Female subjects should not be pregnant or breast-feeding.
- No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- General inclusion criteria:
- Male or female. Age ≥ 18 years and ≤75 years
- Written (signed) informed consent.
- Able to comply with study and follow-up procedures.
- Good compliance with the treatment plan。
- Consent to provide tissue sample。
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XELOX | Experimental | Drug: XELOXClinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically documented gastricadenocarcinoma with Lauren classification Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable
- Measurable disease is required
- Karnofsky score 80%.
- Physical condition and adequate organ function to ensure the success of abdominal surgery.
- Life expectancy ≥12 weeks.
Key exclusion criteria (17 listed)
- Pregnant or lactating (in case of potentially childbearing woman, pregnancy test is positive)
- Patients of child-bearing age or the potential to father a child who refuse to use adequate contraception
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- History of another malignancy in the last 5 years with the exception of the following:
- Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy. Prior treatment for locally advanced or metastatic gastric cancer. Any metastatic disease will render patient ineligible according to AJCC staging manual.
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 |
|---|---|---|
| XELOXPatients will be given the perioperative chemotherapy as below once recruited: Capecitabine ：500 mg tablets（Roche） Oxaliplatin：50mg/10ml（according to daily practice in each center） Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, bid ， d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week) Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks | Drug | XELOX |
Primary outcome
the response rate of XELOX in the neoadjuvant setting of LAGC
Time frame: 6 months after the last subject participating in
the response rate evaluation will be based on tumor assessment with follow-up, including chest and upper-abdominal During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after)., brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.
5 secondary outcomes
the progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT2-3/N+M0,or cT4aN+M0)
Time frame: 42 months after the last subject participating in
percentage of pathological response
Time frame: 10 months after the last subject participating in
Percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments
Time frame: 1 month after the last date of treatment
Overall survival
Time frame: 3 years after the last subject participating in
QOL during the whole period of treatment
Time frame: 1 years after the last date of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Derived from this study: PubMed 31239311Yu Y, Fang Y, Shen Z, Wang Y, Yan M, Cao H, Liu Y, Wang X, Cui Y, Liu F, Chen W, Li W, Li Q, Jiang H, Sun Y, Liu T. Oxaliplatin plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma in Combination with D2 Gastrectomy: NEO-CLASSIC Study. Oncologist. 2019 Oct;24(10):1311-e989. doi: 10.1634/theoncologist.2019-0416. Epub 2019 Jun 25.
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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.
Tianshu Liu, Doctor principal investigator
Medical oncology Shanghai zhongshan hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XELOX in people with Gastric Adenocarcinoma, run by Shanghai Zhongshan Hospital 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 14 inclusion and 17 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 18 Dec 2015. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianshu Liu, Doctor (+861368 1973 996, liu.tianshu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the response rate of XELOX in the neoadjuvant setting of LAGC (time frame: 6 months after the last subject participating in). 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 NCT01880632, 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 18 Dec 2015.