Gastric CancerPhase 2repeatNCT01665274
Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer
A Phase 2 study testing Capecitabine, Oxaliplatin and D2 resection in people with Gastric Cancer, run by Harbin Medical University at 1 site in China.
Trial summary
The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative chemotherapy is superior or not to operation directly for locally advanced gastric cancer in terms of 3 year disease-free survival (DFS) rate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Capecitabine, Oxaliplatin and D2 resection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Sep 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Karnofsky performance status of ≥60 %.
- Histologically confirmed gastric adenocarcinoma, staged pathologically or clinically, stage cT2-4N+M0, and cT4N0M0.
- Patients had to have adequate renal function (serum creatinine ≤1 times the upper limit of normal [ULN]), hepatic function (total bilirubin ≤1·5 times the ULN, aspartate or alanine aminotransferase ≤2·5 times the ULN, alkaline phosphatase ≤2·5 times the ULN, Serum albumin ≥30g/L), and haematological function (absolute neutrophil count ≥1·5×10⁹/L and platelet count ≥100×10⁹/L)
Who cannot join
- Pregnant or lactating women.
- According to the AJCC TMN 7.0, Any evidence of metastatic (TxNxM1) patients(including presence of tumor cells in the ascites).
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- Has uncontrolled epilepsy, central nervous system diseases or mental disorders of history.
- Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
Show all 21Show fewer
- Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
- Known peripheral neuropathy ≥ CTCAEv3 grade 1 (Common Terminology for Adverse Events). Absence of deep tendon reflexes as the sole neurologic abnormality does not render the patient ineligible.
- Organ allografts requiring immunosuppressive therapy.
- Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
- Moderate or severe renal impairment [creatinine clearance equal to or below 50 ml/min (calculated according to Cockroft and Gault)], or serum creatinine > 1.5 x upper limit of normal (ULN).
- Any of the following laboratory values:
- Absolute neutrophil count (ANC) < 1.5 x 109/L
- Platelet count < 100 x 109/L
- Total bilirubin > 1.5 x ULN
- ALAT, ASAT > 2.5 x ULN
- Alkaline phosphatase > 2.5 x ULN.
- Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency.
- Hypersensitivity to platinum compounds or any of the components of the study medications.
- Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Single Center Controlled Study of Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection
The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative chemotherapy is superior or not to operation directly for locally advanced gastric cancer in terms of 3 year disease-free survival (DFS) rate.
Read the detailed description
The patients of gastric cancer have been divided into two parts in random.The test group receive perioperative chemotherapy (XELOX) six cycles and the control group administrate the same program after operation. The two groups have the same staging and eligibility criteria.The 3 year disease-free survival (DFS) rate and 5 year overall survival (OS) rate maybe the last evaluation standard.
- Conditions
- Gastric Cancer
- Being tested
- Capecitabine, Oxaliplatin, D2 resection
- Keywords
- xelox, advanced gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called xeloda
Capecitabine 1,000 mg/m² twice daily, d1-14, q3w
OxaliplatinDrug
Also called eloxatin
Oxaliplatin IV infusion, 130mg/m² d1, q3w
D2 resectionProcedure or surgery
D2 resection
| Study group | Role | What they receive |
|---|---|---|
| XELOX adjuvant group | Active comparator | D2 resection
XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles Receives: Drug: Capecitabine; Drug: Oxaliplatin; Procedure: D2 resection |
| XELOX neoadjuvant | Experimental | XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy before operation.
D2 resection
After operation:
CR/PR: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy after operation. SD/PD:,ST(Drug: S-1，40-75mg twice daily. d1-14 q3w Drug: Paclitaxel IV infusion 135mg/m2 d1; q3w) 3 cycles chemotherapy after operation. Receives: Drug: Capecitabine; Drug: Oxaliplatin; Procedure: D2 resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year DFS
Measured: 3 years after surgery
Secondary outcomes (4)
adverse events
Measured: From date of randomization until the end of the study, assessed up to 5 years
response rate
Measured: evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy
R0 resection rate
Measured: after the pathological examination of resected speciments ie within 1 month after the operation
overall survival
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startSep 2013
- Primary completionAug 2020
- Study completionSep 2022
Why it stopped: we are working on a larger similar multicenter cinical trials as a participant.so in order to avoid conflicts of interest, we have to suspended this project.
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.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingwei Xue, Harbin Medical University
- Investigators
- Yingwei Xue, Phd, MD, Study director, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665274
- Sponsor's protocol ID
- GCPCT1205/repeat
- Acronym
- repeat
- Status last verified
- Sep 2022
- First submitted
- 5 Aug 2012
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Center Controlled Study of Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection
- ClinicalTrials.gov ID
- NCT01665274
- Acronym / sponsor ID
- repeat / GCPCT1205/repeat
- Conditions
- Gastric Cancer
- Keywords
- xelox, advanced gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: we are working on a larger similar multicenter cinical trials as a participant.so in order to avoid conflicts of interest, we have to suspended this project.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2020 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 15 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 demonstrate that capecitabine/oxaliplatin as perioperative chemotherapy is superior or not to operation directly for locally advanced gastric cancer in terms of 3 year disease-free survival (DFS) rate.
Detailed description
The patients of gastric cancer have been divided into two parts in random.The test group receive perioperative chemotherapy (XELOX) six cycles and the control group administrate the same program after operation. The two groups have the same staging and eligibility criteria.The 3 year disease-free survival (DFS) rate and 5 year overall survival (OS) rate maybe the last evaluation standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XELOX adjuvant group | Active comparator | Drug: Capecitabine, Drug: Oxaliplatin, Procedure: D2 resectionD2 resection XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles |
| XELOX neoadjuvant | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Procedure: D2 resectionXELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy before operation. D2 resection After operation: CR/PR: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy after operation. SD/PD:,ST(Drug: S-1，40-75mg twice daily. d1-14 q3w Drug: Paclitaxel IV infusion 135mg/m2 d1; q3w) 3 cycles chemotherapy after operation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Karnofsky performance status of ≥60 %.
- Histologically confirmed gastric adenocarcinoma, staged pathologically or clinically, stage cT2-4N+M0, and cT4N0M0.
- Patients had to have adequate renal function (serum creatinine ≤1 times the upper limit of normal [ULN]), hepatic function (total bilirubin ≤1·5 times the ULN, aspartate or alanine aminotransferase ≤2·5 times the ULN, alkaline phosphatase ≤2·5 times the ULN, Serum albumin ≥30g/L), and haematological function (absolute neutrophil count ≥1·5×10⁹/L and platelet count ≥100×10⁹/L)
Key exclusion criteria (21 listed)
- Pregnant or lactating women.
- According to the AJCC TMN 7.0, Any evidence of metastatic (TxNxM1) patients(including presence of tumor cells in the ascites).
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- Has uncontrolled epilepsy, central nervous system diseases or mental disorders of history.
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 |
|---|---|---|
| CapecitabineAlso: xelodaCapecitabine 1,000 mg/m² twice daily, d1-14, q3w | Drug | XELOX adjuvant group, XELOX neoadjuvant |
| OxaliplatinAlso: eloxatinOxaliplatin IV infusion, 130mg/m² d1, q3w | Drug | XELOX adjuvant group, XELOX neoadjuvant |
| D2 resectionD2 resection | Procedure or surgery | XELOX adjuvant group, XELOX neoadjuvant |
Primary outcome
3-year DFS
Time frame: 3 years after surgery
4 secondary outcomes
adverse events
Time frame: From date of randomization until the end of the study, assessed up to 5 years
response rate
Time frame: evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy
R0 resection rate
Time frame: after the pathological examination of resected speciments ie within 1 month after the operation
overall survival
Time frame: 5 years after surgery
Results and safety
The study was stopped early (reason given: we are working on a larger similar multicenter cinical trials as a participant.so in order to avoid conflicts of interest, we have to suspended this project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Yingwei Xue, Phd, MD study director
Harbin Medical University
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 Capecitabine, Oxaliplatin and D2 resection in people with Gastric Cancer, run by Harbin Medical 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 3 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: stopped early, as of the sponsor's last update on 3 Oct 2022. 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?
The study was stopped early (reason given: we are working on a larger similar multicenter cinical trials as a participant.so in order to avoid conflicts of interest, we have to suspended this project.). 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?
3-year DFS (time frame: 3 years after surgery). 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 3 Oct 2022.