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

Phase 1

• Conditions: Rectal Carcinoma
• Interventions: Drug: S-1; Drug: Oxaliplatin; Radiation: Radiation

• Registration Number: NCT01227239
• Lead Sponsor: Japan Clinical Cancer Research Organization

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-25
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-26
• Last Update Posted: 2012-11-27
• Primary Completion: 2013-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Radiation	-
1	S-1	-
1	Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Nagoya University Graduate School of Medicine; 🇯🇵 Nagoya, Japan

Osaka Medical College; 🇯🇵 Osaka, Japan

Tokyo University; 🇯🇵 Tokyo, Japan

Jichi Medical University Hospital; 🇯🇵 Tochigi, Japan

Teikyo University; 🇯🇵 Tokyo, Japan

Cancer Institute Hospital; 🇯🇵 Tokyo, Japan