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

Rectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01227239
• Other study ID #: JACCRO CC-04
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: October 18, 2010
• Last updated: November 26, 2012
• Start date: September 2010
• Est. completion date: August 2016

Study information

• Verified date: November 2012
• Source: Japan Clinical Cancer Research Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: August 2016
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Rectal Carcinoma
• Rectal Neoplasms

Intervention

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.
• 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)

Locations

Country	Name	City	State
Japan	Nagoya University Graduate School of Medicine	Nagoya
Japan	Osaka Medical College	Osaka
Japan	Jichi Medical University Hospital	Tochigi
Japan	Cancer Institute Hospital	Tokyo
Japan	Teikyo University	Tokyo
Japan	Tokyo University	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Cancer Research Organization	Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	R0 resection rate		12-16 weeks	No
Secondary	down staging rate		12-16 weeks	No
Secondary	local reccurence rate		3 years	No
Secondary	desease free survuval		3 years	No
Secondary	safety		16-20 weeks	Yes