Gastric Cancer, Adjuvant Chemotherapy, XOPhase 3NCT01935778
Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer at Stage IIIb and IV(KCSG ST15-08): TRIUMPH
A Phase 3 study testing Docetaxel and capecitabine and oxaliplatin and capecitabine and oxaliplatin in people with Gastric Cancer, Adjuvant Chemotherapy, XO, run by Asan Medical Center at 1 site in South Korea.
Trial summary
multicenter, open label, randomaized, phase III The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are currently accepted as a standard therapy among the AGC patients who were performed gastrectomy… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Cancer, Adjuvant Chemotherapy, XO
- What is being tested?
- Docetaxel and capecitabine and oxaliplatin and capecitabine and oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2013to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients who voluntarily provide written informed consent prior to entering into this study 2. Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically 3. Patients who underwent radical resection with wide lymph node dissection. 4. TNM(tumor/lymph node/metastasis) stage of IIIB or IV on post-operative staging.
- 5. Patients who can be randomized within 6 weeks after surgery
Who cannot join
- 1. Aged < 20 years or ≥ 76 years 2. Eastern Cooperative Oncology Group (ECOG) performance status ≥2 3. Patients who underwent surgery for neoplasm in stomach in the past 4. History of malignant disease The following cases can be included in this study.
- Adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
- Other cancer for which more than 5 years have passed since chemotherapy was completed and disease-free status has been maintained for 5 years or more 5. Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node) 6. Residual cancer on post-operative staging (R1 and R2 resection) 7. Patients who received alleviator, adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer 8. Patients who participated in another clinical trial or received another investigational product within 30 days prior to providing informed consent 9. Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment.
- 10. Patients with past uncontrolled seizures, central nervous system or psychological disorder which makes it impossible to provide informed consent and is so clinically significant as to interfere with oral medication 11. Uncontrolled active infection or sepsis 12. Deep vein thrombosis within 4 weeks prior to providing informed consent 13. Severe acute or chronic disease which may deteriorate the capability to participate in the study or make it difficult to interpret the study results 14. Not fully recovered from surgery 15. Patients who may have difficulty in absorbing orally administered study drug
- Intolerance to oral administration or malabsorption
- Lack of physical integrity of upper gastrointestinal tract is not recovered
Show all 12Show fewer
- Absorption disorder for any reason
- Ileus
- Chronic inflammatory bowel disease
- Wide resection of small intestine or other disease limiting drug absorption (e.g., gastric dumping syndrome, features of rapid small bowel transit time, absorption disorder after intestine surgery) 16. Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment 17. Pregnant women or breastfeeding women. Women of childbearing potential whose pregnancy test result is positive 18. Bone marrow and organ function inappropriate for administration of study drug: I. Absolute neutrophil count < 1.5 x 109/L II. Platelet < 100 x 109/L III. Hemoglobin ≤ 9 g/dL IV. AST> 2.5 x ULN, ALT> 2.5 x ULN V. ALP > 2.5 x ULN VI. Total bilirubin > 1.5 x ULN VII. Serum creatinine > 1.5 x ULN or creatinine clearance ≤ 50 mL/min Creatinine clearance will be calculated by Cockcroft-Gault formula or collection of 24-hour urine, and patients with creatinine clearance of ≤ 50 mL/min will be excluded.
- 19. Peripheral neuropathy with clinical symptoms of Grade ≥2 (NCI CTCAE v4.03) 20. History of hypersensitivity to the investigational products (Docetaxel, Capecitabine, and Oxaliplatin).
- 21. Patients who are taking immunosuppressant or other prohibited concomitant medication 22. Patients who are receiving anticoagulant therapy with warfarin or other coumarins.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Min-Hee Ryu, M.D., Ph.D., +82230105935, miniryu@amc.seoul.kr
Ryoo Back-Yeol, MD,PhD
About this study
Official title: A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) Who Received Radical Resection(KCSG ST15-08)
multicenter, open label, randomaized, phase III
The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are currently accepted as a standard therapy among the AGC patients who were performed gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as one of the best treatments for IIB and IV(M0) stage AGC patients who were performed gastrectomy.
- Being tested
- Docetaxel and capecitabine and oxaliplatin, capecitabine and oxaliplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel and capecitabine and oxaliplatinDrug
Also called docetaxel/xeloda/oxliplatin
Docetaxel 60 mg/m² IV Day 1 Capecitabine 800 mg/m² bid (Day 1-Day 14) Oxaliplatin 100 mg/m² IV Day 1
capecitabine and oxaliplatinDrug
Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1
| Study group | Role | What they receive |
|---|---|---|
| capecitabine and oxaliplatin | Active comparator | Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1 Receives: Drug: capecitabine and oxaliplatin |
| Docetaxel and capecitabine and oxaliplatin | Experimental | * Docetaxel 60 mg/m² will be intravenously infused over at least 1 hour on Day 1 every 3 weeks.
* Oxaliplatin 100 mg/m² will be intravenously infused over at least 2 hours on Day 1 every 3 weeks.
* Capecitabine 800 mg/m² will be orally administered twice daily from Day 1 evening to Day 15 morning every 3 weeks. (Total 1,600 mg/m² daily) Receives: Drug: Docetaxel and capecitabine and oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
To compare 3-year disease-free survival (DFS) between the two groups. DFS is defined as the time from randomization date to objective tumor recurrence as assessed with the RECIST 1.1, onset of new gastric cancer, or death.
Measured: 3 years
Secondary outcomes (2)
overall survival
Overall survival (OS): Overall survival is defined as the time from randomization date to date of death by any cause. If death cannot be confirmed, survival time will be the last date when the subject's survival is confirmed or the date when the contact is lost, whichever comes first. For subjects lost to follow-up, the last contact date will be entered.
Measured: 6 years
safety profile
Safety evaluation: Type and severity of adverse events will be compared between the two groups.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study start2 Oct 2013
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer, Adjuvant Chemotherapy, XOStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Severance Hospital, Inha University Hospital, Hallym University Medical Center
- Responsible party
- Principal investigator, Min-Hee Ryu, Asan Medical Center
- Investigators
- Min-Hee Ryu, M.D.,Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935778
- Sponsor's protocol ID
- AMC1303
- Status last verified
- Feb 2024
- First submitted
- 1 Sep 2013
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.
PubMed 22226517Sym SJ, Ryu MH, Kang HJ, Lee SS, Chang HM, Lee JL, Kim TW, Yook JH, Oh ST, Kim BS, Kang YK. Phase I study of 3-weekly docetaxel, capecitabine and oxaliplatin combination chemotherapy in patients with previously untreated advanced gastric cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):373-80. doi: 10.1007/s00280-009-1171-x. Epub 2009 Nov 21.
PubMed 19936751Evans D, Miner T, Akerman P, Millis R, Jean M, Kennedy T, Safran H. A phase I study of docetaxel, oxaliplatin, and capecitabine in patients with metastatic gastroesophageal cancer. Am J Clin Oncol. 2007 Aug;30(4):346-9. doi: 10.1097/COC.0b013e318042d582.
PubMed 17762433Lauro LD, Sergi D, Belli F, Fattoruso SI, Arena MG, Pizzuti L, Vici P (2013) Docetaxel, oxaliplatin, and capecitabine (DOX) combination chemotherapy for metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. J Clin Oncol 31 (Suppl; abstract e15065)
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) Who Received Radical Resection(KCSG ST15-08)
- ClinicalTrials.gov ID
- NCT01935778
- Acronym / sponsor ID
- AMC1303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Severance Hospital, Inha University Hospital, Hallym University Medical Center
- Study start
- 2 Oct 2013 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Sep 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.
multicenter, open label, randomaized, phase III
The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are currently accepted as a standard therapy among the AGC patients who were performed gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as one of the best treatments for IIB and IV(M0) stage AGC patients who were performed gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| capecitabine and oxaliplatin | Active comparator | Drug: capecitabine and oxaliplatinCapecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1 |
| Docetaxel and capecitabine and oxaliplatin | Experimental | Drug: Docetaxel and capecitabine and oxaliplatin* Docetaxel 60 mg/m² will be intravenously infused over at least 1 hour on Day 1 every 3 weeks. * Oxaliplatin 100 mg/m² will be intravenously infused over at least 2 hours on Day 1 every 3 weeks. * Capecitabine 800 mg/m² will be orally administered twice daily from Day 1 evening to Day 15 morning every 3 weeks. (Total 1,600 mg/m² daily) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients who voluntarily provide written informed consent prior to entering into this study 2. Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically 3. Patients who underwent radical resection with wide lymph node dissection. 4. TNM(tumor/lymph node/metastasis) stage of IIIB or IV on post-operative staging.
- 5. Patients who can be randomized within 6 weeks after surgery
Key exclusion criteria (12 listed)
- 1. Aged < 20 years or ≥ 76 years 2. Eastern Cooperative Oncology Group (ECOG) performance status ≥2 3. Patients who underwent surgery for neoplasm in stomach in the past 4. History of malignant disease The following cases can be included in this study.
- Adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
- Other cancer for which more than 5 years have passed since chemotherapy was completed and disease-free status has been maintained for 5 years or more 5. Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node) 6. Residual cancer on post-operative staging (R1 and R2 resection) 7. Patients who received alleviator, adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer 8. Patients who participated in another clinical trial or received another investigational product within 30 days prior to providing informed consent 9. Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment.
- 10. Patients with past uncontrolled seizures, central nervous system or psychological disorder which makes it impossible to provide informed consent and is so clinically significant as to interfere with oral medication 11. Uncontrolled active infection or sepsis 12. Deep vein thrombosis within 4 weeks prior to providing informed consent 13. Severe acute or chronic disease which may deteriorate the capability to participate in the study or make it difficult to interpret the study results 14. Not fully recovered from surgery 15. Patients who may have difficulty in absorbing orally administered study drug
- Intolerance to oral administration or malabsorption
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 |
|---|---|---|
| Docetaxel and capecitabine and oxaliplatinAlso: docetaxel/xeloda/oxliplatinDocetaxel 60 mg/m² IV Day 1 Capecitabine 800 mg/m² bid (Day 1-Day 14) Oxaliplatin 100 mg/m² IV Day 1 | Drug | Docetaxel and capecitabine and oxaliplatin |
| capecitabine and oxaliplatinCapecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1 | Drug | capecitabine and oxaliplatin |
Primary outcome
disease-free survival
Time frame: 3 years
To compare 3-year disease-free survival (DFS) between the two groups. DFS is defined as the time from randomization date to objective tumor recurrence as assessed with the RECIST 1.1, onset of new gastric cancer, or death.
2 secondary outcomes
overall survival
Time frame: 6 years
safety profile
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Results publication: PubMed 22226517Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.
- Results publication: PubMed 19936751Sym SJ, Ryu MH, Kang HJ, Lee SS, Chang HM, Lee JL, Kim TW, Yook JH, Oh ST, Kim BS, Kang YK. Phase I study of 3-weekly docetaxel, capecitabine and oxaliplatin combination chemotherapy in patients with previously untreated advanced gastric cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):373-80. doi: 10.1007/s00280-009-1171-x. Epub 2009 Nov 21.
- Results publication: PubMed 17762433Evans D, Miner T, Akerman P, Millis R, Jean M, Kennedy T, Safran H. A phase I study of docetaxel, oxaliplatin, and capecitabine in patients with metastatic gastroesophageal cancer. Am J Clin Oncol. 2007 Aug;30(4):346-9. doi: 10.1097/COC.0b013e318042d582.
- Results publicationLauro LD, Sergi D, Belli F, Fattoruso SI, Arena MG, Pizzuti L, Vici P (2013) Docetaxel, oxaliplatin, and capecitabine (DOX) combination chemotherapy for metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. J Clin Oncol 31 (Suppl; abstract e15065)
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.
Min-Hee Ryu, M.D.,Ph.D principal investigator
Asan Medical Center
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 Docetaxel and capecitabine and oxaliplatin and capecitabine and oxaliplatin in people with Gastric Cancer, Adjuvant Chemotherapy, XO, run by Asan Medical Center 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 2 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 28 Feb 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 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min-Hee Ryu, M.D.,Ph.D (+82230105935, miniryu@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 3 years). 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 NCT01935778, which also lists 4 linked publications.
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 28 Feb 2024.