Preoperative CRT using IMRT for LARC

JRCT ID: jRCTs051180039

Registered date:30/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Locally advanced rectal cancer
• Date of first enrollment: 17/02/2017
• Target sample size: 15
• Study type: Interventional

Intervention(s)

1) Preoperative chemoradiotherapy
i) Intensity-modulated radiotherapy: 45 Gy/25frs/5weeks
ii) S-1 80-120mg/body, p.o (days 1-5, 8-12, 22-26, 29-33), CPT-11, 60 mg/m2, div (days 1, 8, 22, 29)
2) Operation

Outcome(s)

• Primary Outcome: The rate of grade 2 acute gastrointestinal toxicity
• Secondary Outcome: The rate of more than grade 2 acute diarrhea, the rate of more than grade 3 acute diarrhea, the rate of acute gastrointestinal toxicity based on the patient reported outcome, the rate of acute adverse events, the rate of late adverse events, overall survival, progression-free survival, the rate of pathological complete response, the rate of the completion of the planned treatment, the rate of decreased therapeutic intensity, the rate of R0 resection, the rate of down staging, the rate of the surgery associated complication

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Histologically confirmed adenocarcionma
2) Resectable rectal cancer
i) clinically T3-4 and N0-2
ii) Ra or Rb
iii) Inferior margin of tumor is located below the peritoneal reflection
3) No hepatic, peritoneal metastasis
4) 20-80 years
5) Performance Status: 0-2
6) No previous treatment
7) Adequate organ function
8) Able to take drugs orally
9) Written informed consent

Exclude criteria

1) Active other synchronous cancer
2) Receiving flucytosin or atazonavi
3) Suffering the active infection
4) Uncontrollable comorbidity
5) Pregnant or breastfeeding women,
6) Reciving steroid medication
7) Difficult to join due to mental disorder

Related Information

• Primary Sponsor: Mizowaki Takashi
• Source(s) of Monetary Support: Japan Society of Clinical Oncology
• Secondary ID(s): UMIN000024549