Gastric CancerPhase 3NCT03961867
Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma
A Phase 3 study testing Docetaxel and Oxaliplatin in people with Gastric Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer. Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Docetaxel and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2020to Sep 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consensus of patients
- be able to receive oral administration
- from 18 to 75 years old
- be proven to be primary adenocarcinoma of stomach and staged II or III by pathological evidences
- without other chemotherapy and/or radiation against to the disease
- normal function of other organs including heart,liver ,kidney and so on
- Eastern Cooperative Oncology Group performance status:0~2
Who cannot join
- history of other malignancy
- allergic reaction to S-1 or oxaliplatin of docetaxel
- be enrolling in other clinical trials
- abnormal GI tract function
- dysfunction of other organs
- 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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, 510655
Jian Xiao, MD, xiao_jian@139.com
About this study
Official title: S-1 Plus Docetaxel(DS) Versus S-1 Plus Oxaliplatin(SOX) as Postoperative Therapy for Stage II / III Gastric Cancer, a Randomized Controlled Trial
S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.
Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.
This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.
Read the detailed description
In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ≤2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion.
Group DS:
S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.
Docetaxel 40mg/m2/3w from the second to the seventh cycles.
Group SOX:
S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.
Oxaliplatin 130mg/m2/3w from the first to the eight cycles.
The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.
- Conditions
- Gastric Cancer
- Being tested
- Docetaxel, Oxaliplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called S-1
S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.
Docetaxel 40mg/m2/3w from the second to the seventh cycles.
OxaliplatinDrug
Also called S-1
S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.
Oxaliplatin 130mg/m2/3w from the first to the eight cycles.
| Study group | Role | What they receive |
|---|---|---|
| DS | Experimental | D2 resection -- S1 * 1 cycle + DS * 6 cycles + S1 * 9 cycles Receives: Drug: Docetaxel |
| SOX | Active comparator | D2 resection -- SOX * 8 cycles + S1 * 8 cycles Receives: Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
The interval from randomization to local recurrence, distant metastasis, death or the last follow-up
Measured: 3 year
Secondary outcomes (2)
overall survival
The interval from randomization to death or the last follow-up
Measured: 5 year
Treatment related Adverse Events
According to CTC version 5
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 posted23 May 2019
- Study start15 Sep 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2025 (estimated)
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 Sixth Affiliated Hospital, Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Jian Xiao, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961867
- Sponsor's protocol ID
- SAHMO203
- Status last verified
- May 2021
- First submitted
- 22 May 2019
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-1 Plus Docetaxel(DS) Versus S-1 Plus Oxaliplatin(SOX) as Postoperative Therapy for Stage II / III Gastric Cancer, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03961867
- Acronym / sponsor ID
- SAHMO203
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 May 2019 (actual)
- 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.
S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.
Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.
This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.
Detailed description
In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ≤2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion.
Group DS:
S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.
Docetaxel 40mg/m2/3w from the second to the seventh cycles.
Group SOX:
S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.
Oxaliplatin 130mg/m2/3w from the first to the eight cycles.
The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS | Experimental | Drug: DocetaxelD2 resection -- S1 * 1 cycle + DS * 6 cycles + S1 * 9 cycles |
| SOX | Active comparator | Drug: OxaliplatinD2 resection -- SOX * 8 cycles + S1 * 8 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- informed consensus of patients
- be able to receive oral administration
- from 18 to 75 years old
- be proven to be primary adenocarcinoma of stomach and staged II or III by pathological evidences
- without other chemotherapy and/or radiation against to the disease
Key exclusion criteria (7 listed)
- history of other malignancy
- allergic reaction to S-1 or oxaliplatin of docetaxel
- be enrolling in other clinical trials
- abnormal GI tract function
- dysfunction of other organs
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 |
|---|---|---|
| DocetaxelAlso: S-1S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles. Docetaxel 40mg/m2/3w from the second to the seventh cycles. | Drug | DS |
| OxaliplatinAlso: S-1S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles. Oxaliplatin 130mg/m2/3w from the first to the eight cycles. | Drug | SOX |
Primary outcome
disease-free survival
Time frame: 3 year
The interval from randomization to local recurrence, distant metastasis, death or the last follow-up
2 secondary outcomes
overall survival
Time frame: 5 year
Treatment related Adverse Events
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 1 Jun 2021.
- 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.
Jian Xiao, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel and Oxaliplatin in people with Gastric Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site 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 7 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 1 Jun 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Li, MD (86-20-38285497, lishsh89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 3 year). 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 1 Jun 2021.