Stomach NeoplasmsPhase 3NCT02289547
Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer
A Phase 3 study testing Capecitabine in people with Stomach Neoplasms, run by The Catholic University of Korea at 8 sites in South Korea.
Trial summary
XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 8 sitesSouth Korea
- Study dates
- May 2015to Jan 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven gastric cancer
- Minimum age of 18 years
- Stage IV (regardless of the presence or absence of measurable disease by RECIST criteria) or recurrent after curative surgery
- Negative expression (0, 1) of Her2 Immuno-histochemistry or negative amplification of FISH in Her2 Immuno-histochemistry 2+
- More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-Complete response/non-Progressive disease in cases of non-measurable disease before XELOX chemotherapy)
- Eastern Cooperative Oncology Group Performance status 0-2
Show all 10Show fewer
- Adequate bone marrow function: Absolute neutrophil count ≥ 1,500/ul, Hemoglobin ≥ 8 g/dL, platelet ≥ 100,000/μl
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN (upper normal limit) or creatinine clearance ≥ 60 ml/min
- Adequate hepatic function: serum bilirubin ≤ 2.5 x UNL, AST and ALT ≤ 2.5 x UNL (≤ 5 x ULN in the presence of liver metastasis)
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Who cannot join
- Patients who were exposed previously to any chemotherapy except XELOX for advanced disease
- Patients who received R0 or R1 resection for metastatic or recurrent gastric cancer and without evaluable/measurable disease
- Disease relapsed during or within 4 months after adjuvant therapy
- Patients who had central nervous system and meningeal metastases
- Patients with significant neurologic or psychiatric disorders
- Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
- Any previous or concurrent malignancy except for adequately treated non-melanoma skin cancer, in situ cancer of uterine cervix, non-muscle invasive bladder cancer or malignancy without evidence of recurrence within 5 years
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Recruiting
Buchon St. Mary's Hospital
Buchon
Cuk Jin Lee
- Recruiting
Daejeon St. Mary's Hospital
Daejeon
Ji Chan Park
- Recruiting
Incheon St. Mary's Hospital
Incheon
Jeo Ho Byen
- Recruiting
Seoul St. Mary's Hospital
Seoul
Young Seon Hong
- Recruiting
St. Mary's Hospital
Seoul
In Sook Woo
- Recruiting
Bundang Seoul National hospital
Sungnam
Keun Wook Lee
- Recruiting
St. Vincent's Hospital
Suwon, Gyeonggi-do, 442-723
Byoungyong Shim, Ph.D., M.D, 82-31-249-8457
Byoungyong Shim, M.D., Ph.D
- Recruiting
Ujeongbu St. Mary's Hospital
Ujeongbu
Yoon Ho Ko
About this study
Official title: Randomized Phase 3 Study of Xelox(Capecitabine Plus Oxaliplatin) Followed by Maintenance Capecitabine or Observation in Patients With Advanced Gastric Adenocarcinoma
XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by maintenance Capecitabine or Observation in the gastric cancer patients of stable disease after 6 cycle 1st line of XELOX chemotherapy .
Read the detailed description
Study rationale : Park et al. observed the oxaliplatin as part of XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. The response with XELOX regimen generally occurs earlier. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. This regimen was studied in colon and breast cancer.
- Objective: Primary: To evaluate progression free survival Secondary: To evaluated overall survival, response rate, toxicity profile of chemotherapy, quality of life
- Design :Multicenter randomized controlled phase III open label trial Study subjects will be randomized to two groups in a ratio of 1:1 Subjects More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-complete response/non-progressive disease in cases of non-measurable disease before XELOX chemotherapy),
- Treatment Groups Group A : Capecitabine: Capecitabine 1000mg/m2 bid D1-14, q 3 week Group B : Observation
- Evaluation of response and toxicity A response will be evaluated radiologically every two cycles thereafter, or when progression is suspicious by RECIST criteria version 1.1.
A progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause.
An overall survival is defined as the time from the 1stdate of chemotherapy to the date of death.
Safety will be evaluated every treatment by NCI-CTCAE version 4.0.
- Conditions
- Stomach Neoplasms
- Being tested
- Capecitabine
- Keywords
- chemotherapy, stomach neoplasms
- 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
maintenance capecitabine therapy after six cycles of XELOX
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | observational arm |
| Group B | Experimental | arm of capecitabine maintenance treatment Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Measured: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Secondary outcomes (3)
Overall survival
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until death
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
quality of life in patients measured by QLQ-c30 and STO-22
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Measured: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Toxicity profile of each patients measured by NCI-CTCAE ver 4.0
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Measured: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startMay 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byoungyong Shim, The Catholic University of Korea
- Investigators
- Byoungyong Shim, M.D.,Ph.D, Principal investigator, St.Vincent's Hospital of The Catholic University of KoreaYoung Seon Hong, M.D.,Ph.D, Principal investigator, Seoul St. Mary's Hopital of The Catholic Univerisity of KoreaIn Sook Woo, M.D.,Ph.D, Principal investigator, St. Mary's Hospital of The Catholic University of KoreaJae Ho Byun, M.D.,Ph.D, Principal investigator, Incheon St. Mary's Hopital of The Catholic Univerisity of KoreaCuk Jin Lee, M.D.,Ph.D, Principal investigator, Bucheon St. Mary's Hopital of The Catholic Univerisity of KoreaJi Chan Park, M.D.,Ph.D, Principal investigator, Daejeon St. Mary's Hopital of The Catholic Univerisity of KoreaYoon Ho Ko, M.D.,Ph.D, Principal investigator, Ujeongbu St. Mary's Hopital of The Catholic Univerisity of KoreaKeun Wook Lee, M.D.,Ph.D, Principal investigator, Bundang Seoul National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289547
- Sponsor's protocol ID
- CMCGA1 Trial
- Status last verified
- Jun 2017
- First submitted
- 30 Oct 2014
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
De Vita F, Orditura M, Matano E, Bianco R, Carlomagno C, Infusino S, Damiano V, Simeone E, Diadema MR, Lieto E, Castellano P, Pepe S, De Placido S, Galizia G, Di Martino N, Ciardiello F, Catalano G, Bianco AR. A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients. Br J Cancer. 2005 May 9;92(9):1644-9. doi: 10.1038/sj.bjc.6602573.
PubMed 15856038Park YH, Lee JL, Ryoo BY, Ryu MH, Yang SH, Kim BS, Shin DB, Chang HM, Kim TW, Yuh YJ, Kang YK. Capecitabine in combination with Oxaliplatin (XELOX) as a first-line therapy for advanced gastric cancer. Cancer Chemother Pharmacol. 2008 Apr;61(4):623-9. doi: 10.1007/s00280-007-0515-7. Epub 2007 May 24.
PubMed 17522863Waddell T, Gollins S, Soe W, Valle J, Allen J, Bentley D, Morris J, Lloyd A, Swindell R, Taylor MB, Saunders MP. Phase II study of short-course capecitabine plus oxaliplatin (XELOX) followed by maintenance capecitabine in advanced colorectal cancer: XelQuali study. Cancer Chemother Pharmacol. 2011 May;67(5):1111-7. doi: 10.1007/s00280-010-1322-0. Epub 2010 Jul 30.
PubMed 20676676Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr;20(4):666-73. doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19.
PubMed 19153121Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.
PubMed 18172173Lee GJ, Kim H, Cho SS, Park HS, An HJ, Woo IS, Byun JH, Hong JH, Ko YH, Sun S, Won HS, Jin JY, Park JC, Kim IH, Roh SY, Shim BY. A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation. J Gastric Cancer. 2023 Apr;23(2):315-327. doi: 10.5230/jgc.2023.23.e16.
PubMed 37129155
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 3 Study of Xelox(Capecitabine Plus Oxaliplatin) Followed by Maintenance Capecitabine or Observation in Patients With Advanced Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02289547
- Acronym / sponsor ID
- CMCGA1 Trial
- Conditions
- Stomach Neoplasms
- Keywords
- chemotherapy, stomach neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 13 Nov 2014 (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.
XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by maintenance Capecitabine or Observation in the gastric cancer patients of stable disease after 6 cycle 1st line of XELOX chemotherapy .
Detailed description
Study rationale : Park et al. observed the oxaliplatin as part of XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. The response with XELOX regimen generally occurs earlier. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. This regimen was studied in colon and breast cancer.
- Objective: Primary: To evaluate progression free survival Secondary: To evaluated overall survival, response rate, toxicity profile of chemotherapy, quality of life
- Design :Multicenter randomized controlled phase III open label trial Study subjects will be randomized to two groups in a ratio of 1:1 Subjects More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-complete response/non-progressive disease in cases of non-measurable disease before XELOX chemotherapy),
- Treatment Groups Group A : Capecitabine: Capecitabine 1000mg/m2 bid D1-14, q 3 week Group B : Observation
- Evaluation of response and toxicity A response will be evaluated radiologically every two cycles thereafter, or when progression is suspicious by RECIST criteria version 1.1.
A progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause.
An overall survival is defined as the time from the 1stdate of chemotherapy to the date of death.
Safety will be evaluated every treatment by NCI-CTCAE version 4.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –observational arm |
| Group B | Experimental | Drug: Capecitabinearm of capecitabine maintenance treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven gastric cancer
- Minimum age of 18 years
- Stage IV (regardless of the presence or absence of measurable disease by RECIST criteria) or recurrent after curative surgery
- Negative expression (0, 1) of Her2 Immuno-histochemistry or negative amplification of FISH in Her2 Immuno-histochemistry 2+
- More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-Complete response/non-Progressive disease in cases of non-measurable disease before XELOX chemotherapy)
Key exclusion criteria (7 listed)
- Patients who were exposed previously to any chemotherapy except XELOX for advanced disease
- Patients who received R0 or R1 resection for metastatic or recurrent gastric cancer and without evaluable/measurable disease
- Disease relapsed during or within 4 months after adjuvant therapy
- Patients who had central nervous system and meningeal metastases
- Patients with significant neurologic or psychiatric disorders
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: Xelodamaintenance capecitabine therapy after six cycles of XELOX | Drug | Group B |
Primary outcome
Progression free survival
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
3 secondary outcomes
Overall survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
quality of life in patients measured by QLQ-c30 and STO-22
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Toxicity profile of each patients measured by NCI-CTCAE ver 4.0
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Background: PubMed 15856038De Vita F, Orditura M, Matano E, Bianco R, Carlomagno C, Infusino S, Damiano V, Simeone E, Diadema MR, Lieto E, Castellano P, Pepe S, De Placido S, Galizia G, Di Martino N, Ciardiello F, Catalano G, Bianco AR. A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients. Br J Cancer. 2005 May 9;92(9):1644-9. doi: 10.1038/sj.bjc.6602573.
- Background: PubMed 17522863Park YH, Lee JL, Ryoo BY, Ryu MH, Yang SH, Kim BS, Shin DB, Chang HM, Kim TW, Yuh YJ, Kang YK. Capecitabine in combination with Oxaliplatin (XELOX) as a first-line therapy for advanced gastric cancer. Cancer Chemother Pharmacol. 2008 Apr;61(4):623-9. doi: 10.1007/s00280-007-0515-7. Epub 2007 May 24.
- Background: PubMed 20676676Waddell T, Gollins S, Soe W, Valle J, Allen J, Bentley D, Morris J, Lloyd A, Swindell R, Taylor MB, Saunders MP. Phase II study of short-course capecitabine plus oxaliplatin (XELOX) followed by maintenance capecitabine in advanced colorectal cancer: XelQuali study. Cancer Chemother Pharmacol. 2011 May;67(5):1111-7. doi: 10.1007/s00280-010-1322-0. Epub 2010 Jul 30.
- Background: PubMed 19153121Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr;20(4):666-73. doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19.
- Background: PubMed 18172173Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.
- Derived from this study: PubMed 37129155Lee GJ, Kim H, Cho SS, Park HS, An HJ, Woo IS, Byun JH, Hong JH, Ko YH, Sun S, Won HS, Jin JY, Park JC, Kim IH, Roh SY, Shim BY. A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation. J Gastric Cancer. 2023 Apr;23(2):315-327. doi: 10.5230/jgc.2023.23.e16.
- Individual participant dataSharing planned: Undecided
Related trials for Stomach Neoplasms
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.
Byoungyong Shim, M.D.,Ph.D principal investigator
St.Vincent's Hospital of The Catholic University of Korea
Young Seon Hong, M.D.,Ph.D principal investigator
Seoul St. Mary's Hopital of The Catholic Univerisity of Korea
In Sook Woo, M.D.,Ph.D principal investigator
St. Mary's Hospital of The Catholic University of Korea
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine in people with Stomach Neoplasms, run by The Catholic University of Korea at 8 sites 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 10 inclusion and 7 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byoungyong Shim, M.D., Ph.D (82312497126, shimby@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 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 NCT02289547, which also lists 6 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 14 Jun 2017.