Conditions: Rectal Carcinoma
Keywords: rectal rectum cancer carcinoma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief summary:
Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.

Detailed description:

Arms:
arm 1: Radiation 45 Gy in 25 fractions to the pelvis.

5FU CIVI 225 mg/m2/day by CIVI during radiation

Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. arm 2: Radiation 45 Gy in 25 fractions to the pelvis.

5FU CIVI 225 mg/m2/day by CIVI during radiation

Irinotecan 50 mg/m2 IV weekly for 5 doses.

Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.

Interventions: intervention 1: 5FU intervention 2: Radiation intervention 3: Surgery of resectable lesions intervention 4: Irinotecan
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: