UnknownPhase 1/2

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

Japan45 participantsStarted 2010-09

Plain-language 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 .

Who can participate

Age range20 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Phase I: Determine the Recommended dose (RD)

Timeframe: 10 weeks

Phase II: pathological complete response rate

Timeframe: 12-16 week

Trial details

NCT IDNCT01227239

SponsorJapan Clinical Cancer Research Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

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