MedDataX Logo

Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting

NCT ID: NCT01227239

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

S-1

Intervention Type DRUG

40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.

Oxaliplatin

Intervention Type DRUG

40-60mg/m2/week intravenously on day 1, 8, 22 and 29.

Radiation

Intervention Type RADIATION

Total dose is 50.4Gy (1.8Gy X 28 fractions)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

S-1

40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.

Intervention Type DRUG

Oxaliplatin

40-60mg/m2/week intravenously on day 1, 8, 22 and 29.

Intervention Type DRUG

Radiation

Total dose is 50.4Gy (1.8Gy X 28 fractions)

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients with confirmed locally advanced and non-metastatic rectal adenocarcinoma (clinical stage T3, anyN or T4, anyN)
2. Possible to R0 resection
3. Received no prior therapy
4. Performance status (ECOG) 0-1
5. Normal organ and marrow function.
6. Sufficient oral intake

Exclusion Criteria

1. History of serious allergic reaction
2. Patients without serious complications such as sensory neurotoxicity or serious diarrhea (with watery stool).
3. Female with pregnancy or lactation
4. Have another malignancy in the past 5 years except early stage other cancer that cure by local treatment
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Japan Clinical Cancer Research Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Teikyo University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Toshiaki Watanabe, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tokyo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nagoya University Graduate School of Medicine

Nagoya, , Japan

Site Status

Osaka Medical College

Osaka, , Japan

Site Status

Jichi Medical University Hospital

Tochigi, , Japan

Site Status

Tokyo University

Tokyo, , Japan

Site Status

Cancer Institute Hospital

Tokyo, , Japan

Site Status

Teikyo University

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25612635 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JACCRO CC-04

Identifier Type: -

Identifier Source: org_study_id