Clinical trial · Interventional
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)
NCT01227239CI-TRIAL-00008539unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Carcinoma | Rectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: S-1
- Drug: Oxaliplatin
- Radiation: Radiation
Primary outcomes (2)
- measure
- Phase I: Determine the Recommended dose (RD)
- timeFrame
- 10 weeks
- description
- Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels
- measure
- Phase II: pathological complete response rate
- timeFrame
- 12-16 week
- description
- Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDIshihara 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 25612635