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)

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 Overview

• Status: Unknown
• Conditions: Rectal Carcinoma
• Intervention / Treatment: Drug: S-1; Drug: Oxaliplatin; Radiation: Radiation

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Nagoya, Japan, 466-8550
    • Nagoya University Graduate School of Medicine
  • Osaka, Japan, 569-8686
    • Osaka Medical College
  • Tochigi, Japan, 329-0498
    • Jichi Medical University Hospital
  • Tokyo, Japan, 113-0033
    • Tokyo University
  • Tokyo, Japan, 135-8550
    • Cancer Institute Hospital
  • Tokyo, Japan, 173-8606
    • Teikyo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: S-1; 40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.; Drug: Oxaliplatin; 40-60mg/m2/week intravenously on day 1, 8, 22 and 29.; Radiation: Radiation; Total dose is 50.4Gy (1.8Gy X 28 fractions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Japan Clinical Cancer Research Organization
• Collaborators: Taiho Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Toshiaki Watanabe, M.D., Tokyo University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 21, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Carcinoma; Rectal Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: JACCRO CC-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No