Gastric AdenocarcinomaPhase 2NCT02495493
S-1, Cisplatin-based Chemoradiotherapy, Induction Chemotherapy, Locally Advanced Gastric Adenocarcinoma
A Phase 2 study testing Induction DCS chemotherapy in people with Gastric Adenocarcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Currently, for further improved survival outcome, new cytotoxic compounds such as irinotecan and docetaxel have been combined with 5-FU/cisplatin. However, triplet regimen often burdened with higher toxicity and serious neutropenic infection. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Induction DCS chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Jul 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed gastric cancer
- Clinical stage : - Borrmann type IV
- Large Borrmann type III (>8cm)
- Locally extensive nodal disease
- No evidence of metastasis
- Patients with tumor lesions which can be easily obtained fresh tumor tissue through repeated biopsies.
Show all 10Show fewer
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
- Age≥ 20 years old.
- Performance status of Eastern Cooperative Oncology Group 0 to 2.
- Adequate organ function.
Who cannot join
- metastatic disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
- Pregnant or lactating female
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
Seoul, 120-752
About this study
Official title: S-1 Plus Cisplatin-based Chemoradiotherapy After Induction Chemotherapy for Locally Advanced Gastric Adenocarcinoma : Phase II Trial
Currently, for further improved survival outcome, new cytotoxic compounds such as irinotecan and docetaxel have been combined with 5-FU/cisplatin. However, triplet regimen often burdened with higher toxicity and serious neutropenic infection. Therefore, future trials in neoadjuvant and adjuvant settings need to incorporate new molecular agents which improve efficacy, but less toxicity.
Read the detailed description
Though a significant decrease in its incidence over the last 70 years, gastric cancer remains a significant health problem worldwide. Despite the R0 resection and adjuvant chemotherapy, the prognosis for patients with locally advanced GC remains poor, with 5-year survival rate below 60%. Therefore, active strategy to improve survival outcome is ongoing in gastric cancer. Due to the nature of gastric surgery, postsurgical recovery can be avoided by the administration of systemic therapy and/or radiation prior to the surgical procedure. Furthermore, preoperative therapy has the theoretical advantage of treating an untouched tumor (lack of treatment-induced resistance), with intact vascularization and without fibrotic remodeling of the tumor bed due to surgical trauma. These considerations addressed clinical trials incorporating neoadjuvant treatment for gastric cancer.
Preoperative chemotherapy proved superiority to surgery alone in esophagogastric junction cancer Regarding the pattern of failure, locoregional recurrence after surgical resection has been reported 20-50% of cases. To improve local control and survival outcome, chemoradiotherapy in the neoadjuvant or preoperative setting has been widely applied. In recently published meta-analysis, preoperative chemoradiotherapy combined with surgery significantly reduced the 5-year death rate compared to surgery alone (OR 0.57, P=0.001). Ajani et al reported phase II preoperative chemoradiotherapy (5-fluorouracil/cisplatin and 45 Gy radiotherapy) for localized gastric cancer. Among the 34 stage II/III gastric cancer patients, 30% had pathologic complete response and 24% had pathologic partial response (<10% residual carcinoma). Lowy et al also demonstrated 11% and 63% of complete, partial pathologic responses and preoperative chemoradiotherapy was safe and well tolerated. Based on those rationale, 28 clinical trials with neoadjuvant chemotherapy is ongoing for gastric cancer (clinicaltrial.gov) and the investigators' center is also conducting neoadjuvant chemoradiotherapy trial for localized gastric cancer (NCT01269255).Currently, for further improved survival outcome, new cytotoxic compounds such as irinotecan and docetaxel have been combined with 5-FU/cisplatin. However, triplet regimen often burdened with higher toxicity and serious neutropenic infection. Therefore, future trials in neoadjuvant and adjuvant settings need to incorporate new molecular agents which improve efficacy, but less toxicity.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Induction DCS chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction DCS chemotherapyDrug
docetaxel /cisplatin/S-1 followed by chemoradiotherapy (S-1/cisplatin)
| Study group | Role | What they receive |
|---|---|---|
| Induction DCS chemotherapy | Experimental | 1. Induction chemotherapy -- S-1 35mg/m2 bid day 1-14
* Docetaxel 30 mg/m2 day1, 8
* Cisplatin 30 mg/m2 day1, 8
2. Chemoradiotherapy : S-1 20 mg/m2 bid (Day 1-14, 21-28) cisplatin (30 mg/m2/day, Day 1,8, 21,28), Radiotherapy 45 Gy Receives: Drug: Induction DCS chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic response rate
Measured: 12 weeks
Secondary outcomes (1)
overall survival
Measured: 3,6,9, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJul 2013
- Primary completionApr 2019
- Study completionJul 2019
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 AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Young Rha, Yonsei University
- Investigators
- Sun Young Rha, Principal investigator, Severance Hosiptal, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495493
- Sponsor's protocol ID
- 4-2013-0548
- Status last verified
- Jan 2020
- First submitted
- 8 Jul 2015
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim HS, Koom WS, Baek SE, Kim HI, Jung M, Beom SH, Kang B, Kim H, Chang JS, Choi YY, Son T, Cheong JH, Noh SH, Kim EH, Park JC, Shin SK, Lee SK, Lee YC, Shin SJ, Chung H, Jung I, Chung HC, Lim JS, Hyung WJ, Rha SY. Phase II trial of preoperative sequential chemotherapy followed by chemoradiotherapy for high-risk gastric cancer. Radiother Oncol. 2019 Nov;140:143-149. doi: 10.1016/j.radonc.2019.06.029. Epub 2019 Jul 11.
PubMed 31302344
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-1 Plus Cisplatin-based Chemoradiotherapy After Induction Chemotherapy for Locally Advanced Gastric Adenocarcinoma : Phase II Trial
- ClinicalTrials.gov ID
- NCT02495493
- Acronym / sponsor ID
- 4-2013-0548
- Conditions
- Gastric Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 13 Jul 2015 (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.
Currently, for further improved survival outcome, new cytotoxic compounds such as irinotecan and docetaxel have been combined with 5-FU/cisplatin. However, triplet regimen often burdened with higher toxicity and serious neutropenic infection. Therefore, future trials in neoadjuvant and adjuvant settings need to incorporate new molecular agents which improve efficacy, but less toxicity.
Detailed description
Though a significant decrease in its incidence over the last 70 years, gastric cancer remains a significant health problem worldwide. Despite the R0 resection and adjuvant chemotherapy, the prognosis for patients with locally advanced GC remains poor, with 5-year survival rate below 60%. Therefore, active strategy to improve survival outcome is ongoing in gastric cancer. Due to the nature of gastric surgery, postsurgical recovery can be avoided by the administration of systemic therapy and/or radiation prior to the surgical procedure. Furthermore, preoperative therapy has the theoretical advantage of treating an untouched tumor (lack of treatment-induced resistance), with intact vascularization and without fibrotic remodeling of the tumor bed due to surgical trauma. These considerations addressed clinical trials incorporating neoadjuvant treatment for gastric cancer.
Preoperative chemotherapy proved superiority to surgery alone in esophagogastric junction cancer Regarding the pattern of failure, locoregional recurrence after surgical resection has been reported 20-50% of cases. To improve local control and survival outcome, chemoradiotherapy in the neoadjuvant or preoperative setting has been widely applied. In recently published meta-analysis, preoperative chemoradiotherapy combined with surgery significantly reduced the 5-year death rate compared to surgery alone (OR 0.57, P=0.001). Ajani et al reported phase II preoperative chemoradiotherapy (5-fluorouracil/cisplatin and 45 Gy radiotherapy) for localized gastric cancer. Among the 34 stage II/III gastric cancer patients, 30% had pathologic complete response and 24% had pathologic partial response (<10% residual carcinoma). Lowy et al also demonstrated 11% and 63% of complete, partial pathologic responses and preoperative chemoradiotherapy was safe and well tolerated. Based on those rationale, 28 clinical trials with neoadjuvant chemotherapy is ongoing for gastric cancer (clinicaltrial.gov) and the investigators' center is also conducting neoadjuvant chemoradiotherapy trial for localized gastric cancer (NCT01269255).Currently, for further improved survival outcome, new cytotoxic compounds such as irinotecan and docetaxel have been combined with 5-FU/cisplatin. However, triplet regimen often burdened with higher toxicity and serious neutropenic infection. Therefore, future trials in neoadjuvant and adjuvant settings need to incorporate new molecular agents which improve efficacy, but less toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction DCS chemotherapy | Experimental | Drug: Induction DCS chemotherapy1. Induction chemotherapy -- S-1 35mg/m2 bid day 1-14 * Docetaxel 30 mg/m2 day1, 8 * Cisplatin 30 mg/m2 day1, 8 2. Chemoradiotherapy : S-1 20 mg/m2 bid (Day 1-14, 21-28) cisplatin (30 mg/m2/day, Day 1,8, 21,28), Radiotherapy 45 Gy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed gastric cancer
- Clinical stage : - Borrmann type IV
- No evidence of metastasis
- Patients with tumor lesions which can be easily obtained fresh tumor tissue through repeated biopsies.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Key exclusion criteria (5 listed)
- metastatic disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
- Pregnant or lactating female
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
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 |
|---|---|---|
| Induction DCS chemotherapydocetaxel /cisplatin/S-1 followed by chemoradiotherapy (S-1/cisplatin) | Drug | Induction DCS chemotherapy |
Primary outcome
pathologic response rate
Time frame: 12 weeks
1 secondary outcome
overall survival
Time frame: 3,6,9, 12 weeks
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 14 Jan 2020.
- Derived from this study: PubMed 31302344Kim HS, Koom WS, Baek SE, Kim HI, Jung M, Beom SH, Kang B, Kim H, Chang JS, Choi YY, Son T, Cheong JH, Noh SH, Kim EH, Park JC, Shin SK, Lee SK, Lee YC, Shin SJ, Chung H, Jung I, Chung HC, Lim JS, Hyung WJ, Rha SY. Phase II trial of preoperative sequential chemotherapy followed by chemoradiotherapy for high-risk gastric cancer. Radiother Oncol. 2019 Nov;140:143-149. doi: 10.1016/j.radonc.2019.06.029. Epub 2019 Jul 11.
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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.
Sun Young Rha principal investigator
Severance Hosiptal, Yonsei University Health System
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 Induction DCS chemotherapy in people with Gastric Adenocarcinoma, 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 10 inclusion and 5 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 14 Jan 2020. 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?
pathologic response rate (time frame: 12 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 NCT02495493, 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 14 Jan 2020.