Gastric CancerPhase 3NCT01224652
Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
A Phase 3 study testing Paclitaxel and Irinotecan in people with Gastric Cancer, run by Korean Cancer Study Group at 2 sites in South Korea.
Trial summary
The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Paclitaxel and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Start not givento not given
- 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 confirmed gastric adenocarcinoma in tissue/cell
- Recurrent or metastatic gastric cancer that has progressed following first- line therapy
- Patients must be ≥18 years of age.
- ECOG performance status ≤ 2
- At least one lesion (measurable or non-measurable but evaluable) according to RECIST criteria
- Normal organ and bone marrow function measured within 2 weeks prior to administration of study treatment as defined below: Haemoglobin ≥ 9.0 g/dL White blood cells (WBC) ≥ 3000/µL Absolute neutrophil count (ANC) ≥ 1500/µL Platelet count ≥ 100 x 103/µL Total bilirubin ≤ 1.5 x upper normal limit (UNL) Creatinine clearance ≥ 60 ml/min or Serum creatinine ≤ 1.5 x UNL AST (SGOT)/ALT (SGPT) ≤ 2.5 x UNL unless liver metastases are present in which case it must be ≤ 5x UNL
Show all 9Show fewer
- Life expectancy ≥ 12 weeks.
- Written informed consent
- Provision of informed consent for genetic research (In case of optional genetic research)
Who cannot join
- More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
- Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
- Any previous treatment with a taxane, including paclitaxel and docetaxel or irinotecan, in the metastatic or recurrent setting.
- Patients with second primary cancer, except: adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years.
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
- Ongoing toxicities (>CTCAE grade 2) caused by previous cancer therapy.
Show all 12Show fewer
- Clinically proven gastric outlet obstruction or CTCAE grade 3 or grade 4 upper GI bleeding
- Medically uncontrolled, clinically significant heart disease or infection
- Patients with symptomatic uncontrolled brain metastases.
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- Women who have pregnancy potential or willing to pregnant. Pregnant and breastfeeding women.
- Others Poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection Any psychiatric disorder that prohibits obtaining informed consent and regular follow-up. Inappropriate patient for subjects of this study on investigator's judgment
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Yonsei University Gangnam Severance Hospital
Seoul, 135-720
Jae Yong Cho, M.D., Ph.D.
- Recruiting
Seoul National University Hospital
Seoul
Tae-You Kim, M.D., Ph.D.
About this study
Official title: A Randomized, Multicenter Phase III Study to Assess the Efficacy of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.
- Conditions
- Gastric Cancer
- Being tested
- Paclitaxel, Irinotecan
- Keywords
- gastric cancer, paclitaxel, irinotecan
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Paclitaxel, 70 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 28-day cycle
IrinotecanDrug
irinotecan 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel | Experimental | Paclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle Receives: Drug: Paclitaxel |
| irinotecan | Experimental | irinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Tumor evaluation using RECIST v1.1
Measured: every 8 weeks
Secondary outcomes (2)
Safety
Number of Participants and toxicity grade accordong to NCI-CTCAE v3.0 as a Measure of Safety
Measured: up to 4 weeks after last administration of chemotherapy
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Cancer Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Investigators
- Tae-You Kim, M.D., Ph.D., Study chair, Korean Cancer Stusy Group stomach Cancer Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224652
- Sponsor's protocol ID
- KCSG-ST10-01
- Status last verified
- Oct 2010
- First submitted
- 14 Oct 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee KW, Maeng CH, Kim TY, Zang DY, Kim YH, Hwang IG, Oh SC, Chung JS, Song HS, Kim JW, Jeong SJ, Cho JY. A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01). Oncologist. 2019 Jan;24(1):18-e24. doi: 10.1634/theoncologist.2018-0142. Epub 2018 Aug 20.
PubMed 30126861
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Phase III Study to Assess the Efficacy of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
- ClinicalTrials.gov ID
- NCT01224652
- Acronym / sponsor ID
- KCSG-ST10-01
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, paclitaxel, irinotecan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- Korean Cancer Study GroupUniversity, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- First posted
- 20 Oct 2010 (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 primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paclitaxel | Experimental | Drug: PaclitaxelPaclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle |
| irinotecan | Experimental | Drug: Irinotecanirinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed gastric adenocarcinoma in tissue/cell
- Recurrent or metastatic gastric cancer that has progressed following first- line therapy
- Patients must be ≥18 years of age.
- ECOG performance status ≤ 2
- At least one lesion (measurable or non-measurable but evaluable) according to RECIST criteria
Key exclusion criteria (12 listed)
- More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
- Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
- Any previous treatment with a taxane, including paclitaxel and docetaxel or irinotecan, in the metastatic or recurrent setting.
- Patients with second primary cancer, except: adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years.
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
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 |
|---|---|---|
| PaclitaxelPaclitaxel, 70 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 28-day cycle | Drug | paclitaxel |
| Irinotecanirinotecan 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle | Drug | irinotecan |
Primary outcome
progression-free survival
Time frame: every 8 weeks
Tumor evaluation using RECIST v1.1
2 secondary outcomes
Safety
Time frame: up to 4 weeks after last administration of chemotherapy
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
- Derived from this study: PubMed 30126861Lee KW, Maeng CH, Kim TY, Zang DY, Kim YH, Hwang IG, Oh SC, Chung JS, Song HS, Kim JW, Jeong SJ, Cho JY. A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01). Oncologist. 2019 Jan;24(1):18-e24. doi: 10.1634/theoncologist.2018-0142. Epub 2018 Aug 20.
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.
Tae-You Kim, M.D., Ph.D. study chair
Korean Cancer Stusy Group stomach Cancer Committee
2 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 Paclitaxel and Irinotecan in people with Gastric Cancer, run by Korean Cancer Study Group at 2 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 9 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: status not confirmed, as of the sponsor's last update on 20 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Tae-You Kim, M.D., Ph.D. (82-2-2072-3943, kimty@snu.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: every 8 weeks). 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 NCT01224652, 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 20 Oct 2010.