Gastric CancerPhase 2NCT01286766
Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma
A Phase 2 study testing DCS (docetaxel with cisplatin with TS-1) and DCF (docetaxel with cisplatin with 5-FU) in people with Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. 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?
- DCS (docetaxel with cisplatin with TS-1) and DCF (docetaxel with cisplatin with 5-FU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Jun 2012
- 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
- Histologically/cytologically confirmed gastric adenocarcinoma
- Age 18 to 70 years old
- ECOG performance Status 0~1
- Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA~IV), M0, P0, H0, CY0
- No pretreatment (radiotherapy or chemotherapy) for gastric cancer
- Adequate organ function
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- Hb ≥ 9.0 g/dL
- WBC ≥ 4,000/µL
- ANC ≥ 2,000/µL (*ANC = Neutrophil segs ＋ Neutrophil bands)
- Platelet ≥ 100 × 103/ µL
- Total bilirubin: ≤ 1.5 × UNL
- CCr ≥ 60 ml/min (by laboratory or Cockcroft-Gault Formula)
- AST/ALT, ALP: ≤ 2.5 × UNL
- Written informed consent
Who cannot join
- Distant metastasis on diagnosis
- cT1-2
- Cancer of gastroesophageal junction (GEJ)
- Poor oral intake or absorption deficiency syndrome
- Gastric outlet obstruction, perforation or bleeding
- Medically uncontrollable chronic illness or infection
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- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- History of clinically significant cardiac disease
- Past or concurrent history of neoplasm last < 5 year other than gastric cancer
- Prior gastrectomized patients
- Concomitant administration of any other experimental drug under investigation
- Peripheral neuropathy ≥ NCI-CTC grade 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.
Read the detailed description
Treatment scheme
- Screening period: D-21 to D1 (treatment day)
- Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan.
- Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998)
- Tumor response is assessed every 2 cycles (6 weeks)
- Treatment is repeated until,.
- 4 cycles
- progressive disease
- unacceptable toxicity
- patient's withdrawal
- Gastric surgery should be performed within 4~6 weeks of the last dose of chemotherapy
- Gastric surgery is for curative aim and should include ≥ D2 LN dissection.
- Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin.
- Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy.
- Follow up for survival is repeated every 3 months for 2 years
Study period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months
- Conditions
- Gastric Cancer
- Being tested
- DCS (docetaxel with cisplatin with TS-1), DCF (docetaxel with cisplatin with 5-FU)
- Keywords
- unresectable, locally advanced
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCS (docetaxel with cisplatin with TS-1)Drug
Also called Taxotere, CDDP, TS-1
- S-1: 70 mg/m2 #2 bid PO, D1-14
- Docetaxel 30 mg/m2 IVF (for 1 hr) D1 and D8
- Cisplatin 30 mg/m2 IVF (for 2 hrs, without hydration) D1 and D8, repeated by 3 weeks.
DCF (docetaxel with cisplatin with 5-FU)Drug
Also called 5-FU, Taxotere, CDDP
- 5-FU: 1,000 mg/m2 CI, D1-3
- Docetaxel 60 mg/m2 IVF (for 1 hr) D1 followed by
- Cisplatin 60 mg/m2 IVF (for 2 hrs, with hydration) D1, repeated by 3 weeks.
- Intercycle or intracycle dose modification is indicated if ≥G3 hematologic toxicity (except anemia) or ≥G3 non-hematologic toxicity (except alopecia)
- treatment is repeated until 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| DCS | Active comparator | DCS: docetaxel with cisplatin with TS-1 Receives: Drug: DCS (docetaxel with cisplatin with TS-1) |
| DCF | Active comparator | DCF : docetaxel with cisplatin with 5-FU Receives: Drug: DCF (docetaxel with cisplatin with 5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RECIST(Response Evaluation Criteria in Solid Tumors)
- safety : every cycle adverse event/serious adversr event evaluation from NCI-CTC(version 3.0)
- efficacy : tumor response is assessed every 2 cycles (6weeks) -> tumor response assessment(RECIST<Response Evaluation Criteria in Solid Tumor> 1.0 version use)
Measured: written in the description part below
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startSep 2009
- Primary completionJun 2012
- Study completionJun 2012
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.
- More trials run by Yonsei UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286766
- Sponsor's protocol ID
- 4-2009-0332
- Status last verified
- Dec 2024
- First submitted
- 27 Jan 2011
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01286766
- Acronym / sponsor ID
- 4-2009-0332
- Conditions
- Gastric Cancer
- Keywords
- unresectable, locally advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Jan 2011 (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.
Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.
Detailed description
Treatment scheme
- Screening period: D-21 to D1 (treatment day)
- Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan.
- Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998)
- Tumor response is assessed every 2 cycles (6 weeks)
- Treatment is repeated until,.
- 4 cycles
- progressive disease
- unacceptable toxicity
- patient's withdrawal
- Gastric surgery should be performed within 4~6 weeks of the last dose of chemotherapy
- Gastric surgery is for curative aim and should include ≥ D2 LN dissection.
- Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin.
- Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy.
- Follow up for survival is repeated every 3 months for 2 years
Study period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCS | Active comparator | Drug: DCS (docetaxel with cisplatin with TS-1)DCS: docetaxel with cisplatin with TS-1 |
| DCF | Active comparator | Drug: DCF (docetaxel with cisplatin with 5-FU)DCF : docetaxel with cisplatin with 5-FU |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically/cytologically confirmed gastric adenocarcinoma
- Age 18 to 70 years old
- ECOG performance Status 0~1
- Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA~IV), M0, P0, H0, CY0
- No pretreatment (radiotherapy or chemotherapy) for gastric cancer
Key exclusion criteria (12 listed)
- Distant metastasis on diagnosis
- cT1-2
- Cancer of gastroesophageal junction (GEJ)
- Poor oral intake or absorption deficiency syndrome
- Gastric outlet obstruction, perforation or bleeding
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 |
|---|---|---|
| DCS (docetaxel with cisplatin with TS-1)Also: Taxotere, CDDP, TS-11. S-1: 70 mg/m2 #2 bid PO, D1-14 2. Docetaxel 30 mg/m2 IVF (for 1 hr) D1 and D8 3. Cisplatin 30 mg/m2 IVF (for 2 hrs, without hydration) D1 and D8, repeated by 3 weeks. | Drug | DCS |
| DCF (docetaxel with cisplatin with 5-FU)Also: 5-FU, Taxotere, CDDP1. 5-FU: 1,000 mg/m2 CI, D1-3 2. Docetaxel 60 mg/m2 IVF (for 1 hr) D1 followed by 3. Cisplatin 60 mg/m2 IVF (for 2 hrs, with hydration) D1, repeated by 3 weeks. * Intercycle or intracycle dose modification is indicated if ≥G3 hematologic toxicity (except anemia) or ≥G3 non-hematologic toxicity (except alopecia) * treatment is repeated until 4 cycles | Drug | DCF |
Primary outcome
RECIST(Response Evaluation Criteria in Solid Tumors)
Time frame: written in the description part below
* safety : every cycle adverse event/serious adversr event evaluation from NCI-CTC(version 3.0) * efficacy : tumor response is assessed every 2 cycles (6weeks) -> tumor response assessment(RECIST<Response Evaluation Criteria in Solid Tumor> 1.0 version use)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 DCS (docetaxel with cisplatin with TS-1) and DCF (docetaxel with cisplatin with 5-FU) in people with Gastric Cancer, run by Yonsei University 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 14 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: finished, as of the sponsor's last update on 27 Dec 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
RECIST(Response Evaluation Criteria in Solid Tumors) (time frame: written in the description part below). 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 27 Dec 2024.