NCT01227239

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

2.9 years

First QC Date

October 18, 2010

Last Update Submit

November 26, 2012

Conditions

Rectal Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Phase I: Determine the Recommended dose (RD)

    Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels

    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.

    12-16 week

Secondary Outcomes (5)

  • R0 resection rate

    12-16 weeks

  • down staging rate

    12-16 weeks

  • local reccurence rate

    3 years

  • desease free survuval

    3 years

  • safety

    16-20 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: S-1Drug: OxaliplatinRadiation: Radiation

Interventions

S-1DRUG

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

1
OxaliplatinDRUG

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

1
RadiationRADIATION

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

1

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Nagoya University Graduate School of Medicine

Nagoya, 466-8550, Japan

Location

Osaka Medical College

Osaka, 569-8686, Japan

Location

Jichi Medical University Hospital

Tochigi, 329-0498, Japan

Location

Tokyo University

Tokyo, 113-0033, Japan

Location

Cancer Institute Hospital

Tokyo, 135-8550, Japan

Location

Teikyo University

Tokyo, 173-8606, Japan

Location

Related Publications (1)

  • 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.

    PMID: 25612635DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

S 1 (combination)OxaliplatinRadiation

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPhysical Phenomena

Study Officials

  • Toshiaki Watanabe, M.D.

    Tokyo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 25, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2016

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

JP(6)