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

A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01227239

Enrollment

Registered

2010-10-25

Start date

2010-09-30

Completion date

2016-08-31

Last updated

2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Carcinoma

Brief 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). * In phase II, to evaluate the antitumor effect (pCR rate) and the safety .

Interventions

DRUGS-1

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

DRUGOxaliplatin

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

RADIATIONRadiation

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Phase I: Determine the Recommended dose (RD)	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	12-16 week	Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases.

Secondary

Measure	Time frame
local reccurence rate	3 years
R0 resection rate	12-16 weeks
safety	16-20 weeks
desease free survuval	3 years
down staging rate	12-16 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026