Rectal CarcinomaPhase 1/2NCT01227239
Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting
A Phase 1/2 study testing S-1, Oxaliplatin and Radiation in people with Rectal Carcinoma, run by Japan Clinical Cancer Research Organization at 6 sites in Japan.
Trial summary
The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study. The purpose of this study is as follows, In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rectal Carcinoma
- What is being tested?
- S-1, Oxaliplatin and Radiation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesJapan
- Study dates
- Sep 2010to Aug 2016
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed locally advanced and non-metastatic rectal adenocarcinoma (clinical stage T3, anyN or T4, anyN)
- Possible to R0 resection
- Received no prior therapy
- Performance status (ECOG) 0-1
- Normal organ and marrow function.
- Sufficient oral intake
Who cannot join
- History of serious allergic reaction
- Patients without serious complications such as sensory neurotoxicity or serious diarrhea (with watery stool).
- Female with pregnancy or lactation
- Have another malignancy in the past 5 years except early stage other cancer that cure by local treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Nagoya University Graduate School of Medicine
Nagoya, 466-8550
Osaka Medical College
Osaka, 569-8686
Jichi Medical University Hospital
Tochigi, 329-0498
Tokyo University
Tokyo, 113-0033
Cancer Institute Hospital
Tokyo, 135-8550
Teikyo University
Tokyo, 173-8606
About this study
Official title: A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)
The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study.
The purpose of this study is as follows,
- In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD).
- In phase II, to evaluate the antitumor effect (pCR rate) and the safety .
- Conditions
- Rectal Carcinoma
- Being tested
- S-1, Oxaliplatin, Radiation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.
OxaliplatinDrug
40-60mg/m2/week intravenously on day 1, 8, 22 and 29.
RadiationRadiation
Total dose is 50.4Gy (1.8Gy X 28 fractions)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: S-1; Drug: Oxaliplatin; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine the Recommended dose (RD)
Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels
Measured: 10 weeks
Phase II: pathological complete response rate
Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases.
Measured: 12-16 week
Secondary outcomes (5)
R0 resection rate
Measured: 12-16 weeks
down staging rate
Measured: 12-16 weeks
local reccurence rate
Measured: 3 years
desease free survuval
Measured: 3 years
safety
Measured: 16-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2013 (estimated)
- Study completionAug 2016 (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 Rectal CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japan Clinical Cancer Research Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Investigators
- Toshiaki Watanabe, M.D., Principal investigator, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227239
- Sponsor's protocol ID
- JACCRO CC-04
- Status last verified
- Nov 2012
- First submitted
- 18 Oct 2010
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ishihara S, Matsusaka S, Kondo K, Horie H, Uehara K, Oguchi M, Murofushi K, Ueno M, Mizunuma N, Shinbo T, Kato D, Okuda J, Hashiguchi Y, Nakazawa M, Sunami E, Kawai K, Yamashita H, Okada T, Ishikawa Y, Nakajima T, Watanabe T. A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial). Radiat Oncol. 2015 Jan 23;10:24. doi: 10.1186/s13014-015-0333-8.
PubMed 25612635
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)
- ClinicalTrials.gov ID
- NCT01227239
- Acronym / sponsor ID
- JACCRO CC-04
- Conditions
- Rectal Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Japan Clinical Cancer Research OrganizationUniversity, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 25 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 purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study.
The purpose of this study is as follows,
- In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD).
- In phase II, to evaluate the antitumor effect (pCR rate) and the safety .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-1, Drug: Oxaliplatin, Radiation: Radiation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with confirmed locally advanced and non-metastatic rectal adenocarcinoma (clinical stage T3, anyN or T4, anyN)
- Possible to R0 resection
- Received no prior therapy
- Performance status (ECOG) 0-1
- Normal organ and marrow function.
Key exclusion criteria (4 listed)
- History of serious allergic reaction
- Patients without serious complications such as sensory neurotoxicity or serious diarrhea (with watery stool).
- Female with pregnancy or lactation
- Have another malignancy in the past 5 years except early stage other cancer that cure by local treatment
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 |
|---|---|---|
| S-140mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week. | Drug | 1 |
| Oxaliplatin40-60mg/m2/week intravenously on day 1, 8, 22 and 29. | Drug | 1 |
| RadiationTotal dose is 50.4Gy (1.8Gy X 28 fractions) | Radiation | 1 |
Primary outcome
Phase I: Determine the Recommended dose (RD)
Time frame: 10 weeks
Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels
Phase II: pathological complete response rate
Time frame: 12-16 week
Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases.
5 secondary outcomes
R0 resection rate
Time frame: 12-16 weeks
down staging rate
Time frame: 12-16 weeks
local reccurence rate
Time frame: 3 years
desease free survuval
Time frame: 3 years
safety
Time frame: 16-20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Derived from this study: PubMed 25612635Ishihara S, Matsusaka S, Kondo K, Horie H, Uehara K, Oguchi M, Murofushi K, Ueno M, Mizunuma N, Shinbo T, Kato D, Okuda J, Hashiguchi Y, Nakazawa M, Sunami E, Kawai K, Yamashita H, Okada T, Ishikawa Y, Nakajima T, Watanabe T. A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial). Radiat Oncol. 2015 Jan 23;10:24. doi: 10.1186/s13014-015-0333-8.
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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.
Toshiaki Watanabe, M.D. principal investigator
Tokyo University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S-1, Oxaliplatin and Radiation in people with Rectal Carcinoma, run by Japan Clinical Cancer Research Organization at 6 sites in Japan.
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 6 inclusion and 4 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 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Phase I: Determine the Recommended dose (RD) (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 NCT01227239, 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 27 Nov 2012.