Gastric CancerPhase 3RESCUE-GCNCT02867839
Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer
A Phase 3 study testing Oxaliplatin plus S-1 and S-1 only in people with Gastric Cancer, run by Peking University Cancer Hospital & Institute at 15 sites in China.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Oxaliplatin plus S-1 and S-1 only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 15 sitesChina
- Study dates
- 24 Apr 2017to 1 Sep 2021
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sign written informed consent form
- age ≥ 18 years, ≤69 years
- ECOG status: 0~2
- pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version)
- negative peritoneal cytology
- underwent curative distal gastrectomy with D2 lymph node dissection
- no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
- adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.
Who cannot join
- be enrolled in other clinical trials
- underwent prior antitumor treatment
- allergic reaction to S-1 or oxaliplatin
- abnormal GI tract function
- female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy
- other situation to be judged not adaptive to the study by investigators
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Cancer Hospital Chinese Acadamy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Beijing Hospital
Beijing, Beijing Municipality, 100730
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
The First Affiliated Hospital of Daliang Medical University
Daliang, Liaoning, 116011
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Nanjing General Hospital
Nanjing, Jiangsu, 210002
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
About this study
Official title: A Randomized, Multicentral, Controlled, Phase III Study to Compare Adjuvant Chemotherapy With S-1 Plus Oxaliplatin to S-1 Alone After Curative Distal Gastrectomy in Locally Advanced Gastric Cancer
The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.
Read the detailed description
The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.
- Conditions
- Gastric Cancer
- Being tested
- Oxaliplatin plus S-1, S-1 only
- Keywords
- Gastric cancer, Adjuvant chemotherapy, S1, Oxaliplatin, Survival
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin plus S-1Drug
Also called SOX
8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1
S-1 onlyDrug
Also called S-1
16 cycles of adjuvant chemotherapy with S-1 only
| Study group | Role | What they receive |
|---|---|---|
| A: postoperative Oxaliplatin plus S-1 | Experimental | Patients in arm A will receive standard distal gastrectomy with D2 lymphadenectomy first, and 8 cycles of adjuvant Oxaliplatin plus S-1 (SOX) later.
Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3W S-1: 40~60mg bid, po, d1~14, q3W (6 months) Receives: Drug: Oxaliplatin plus S-1 |
| B: postoperative S-1 only | Active comparator | Patients in arm B will receive standard distal gastrectomy with D2 lymphadenectomy first, and 16 cycles of adjuvant S-1 later.
S-1: 40~60mg bid, po, d1~14, q3W (12 months) Receives: Drug: S-1 only |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Measured: 5 years
Secondary outcomes (2)
overall survival
To evaluate the 1-year, 3-year and 5-year overall survival of GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
Measured: up to 5 years
Incidence of Treatment-Emergent Adverse Events [Safety]
The incidence of chemotherapy related adverse events in GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
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 posted16 Aug 2016 (estimated)
- Study start24 Apr 2017
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: The number of patients enrolled was much less than expected
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.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiafu Ji, MD, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867839
- Sponsor's protocol ID
- RESCUE-GC-2016
- Acronym
- RESCUE-GC
- Status last verified
- Sep 2021
- First submitted
- 4 Aug 2016
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu X, Chen L, Du Y, Fan B, Bu Z, Wang X, Ye Y, Zhang Z, Xiao G, Li F, He Q, Li G, Shen X, Xiong B, Zhu L, Liu J, Liu L, Wu T, Zhou J, Zhang J, Zhao G, Wang X, Liang P, Wang X, Zhang Y, Wu X, Zhang J, Ji X, Zong X, Fu T, Jia Z, Ji J. Postoperative chemotherapy with S-1 plus oxaliplatin versus S-1 alone in locally advanced gastric cancer (RESCUE-GC study): a protocol for a phase III randomized controlled trial. Chin J Cancer Res. 2017 Apr;29(2):144-148. doi: 10.21147/j.issn.1000-9604.2017.02.07.
PubMed 28536493
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicentral, Controlled, Phase III Study to Compare Adjuvant Chemotherapy With S-1 Plus Oxaliplatin to S-1 Alone After Curative Distal Gastrectomy in Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02867839
- Acronym / sponsor ID
- RESCUE-GC / RESCUE-GC-2016
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Adjuvant chemotherapy, S1, Oxaliplatin, Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of patients enrolled was much less than expected
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 16 Aug 2016 (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 purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.
Detailed description
The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: postoperative Oxaliplatin plus S-1 | Experimental | Drug: Oxaliplatin plus S-1Patients in arm A will receive standard distal gastrectomy with D2 lymphadenectomy first, and 8 cycles of adjuvant Oxaliplatin plus S-1 (SOX) later. Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3W S-1: 40~60mg bid, po, d1~14, q3W (6 months) |
| B: postoperative S-1 only | Active comparator | Drug: S-1 onlyPatients in arm B will receive standard distal gastrectomy with D2 lymphadenectomy first, and 16 cycles of adjuvant S-1 later. S-1: 40~60mg bid, po, d1~14, q3W (12 months) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- sign written informed consent form
- age ≥ 18 years, ≤69 years
- ECOG status: 0~2
- pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version)
- negative peritoneal cytology
Key exclusion criteria (6 listed)
- be enrolled in other clinical trials
- underwent prior antitumor treatment
- allergic reaction to S-1 or oxaliplatin
- abnormal GI tract function
- female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy
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 |
|---|---|---|
| Oxaliplatin plus S-1Also: SOX8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1 | Drug | A: postoperative Oxaliplatin plus S-1 |
| S-1 onlyAlso: S-116 cycles of adjuvant chemotherapy with S-1 only | Drug | B: postoperative S-1 only |
Primary outcome
disease-free survival
Time frame: 5 years
2 secondary outcomes
overall survival
Time frame: up to 5 years
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The number of patients enrolled was much less than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Derived from this study: PubMed 28536493Hu X, Chen L, Du Y, Fan B, Bu Z, Wang X, Ye Y, Zhang Z, Xiao G, Li F, He Q, Li G, Shen X, Xiong B, Zhu L, Liu J, Liu L, Wu T, Zhou J, Zhang J, Zhao G, Wang X, Liang P, Wang X, Zhang Y, Wu X, Zhang J, Ji X, Zong X, Fu T, Jia Z, Ji J. Postoperative chemotherapy with S-1 plus oxaliplatin versus S-1 alone in locally advanced gastric cancer (RESCUE-GC study): a protocol for a phase III randomized controlled trial. Chin J Cancer Res. 2017 Apr;29(2):144-148. doi: 10.21147/j.issn.1000-9604.2017.02.07.
- Individual participant dataSharing planned: No
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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.
Jiafu Ji, MD study chair
Peking University Cancer Hospital & Institute
15 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 Oxaliplatin plus S-1 and S-1 only in people with Gastric Cancer, run by Peking University Cancer Hospital & Institute at 15 sites in China.
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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 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 15 sites in China. 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?
The study was stopped early (reason given: The number of patients enrolled was much less than expected). Results are not available in the source record.
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?
disease-free survival (time frame: 5 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 NCT02867839, 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 3 Dec 2024.