Conditions: Rectal Cancer
Keywords: Rectal Cancer Chemoradiation Aflibercept Surgery
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
The purpose of this Phase II study will be to investigate the antiangiogenic agent, aflibercept, in combination with chemoradiation as preoperative treatment for patients with stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.

Detailed description:

Arms:
arm 1: Preoperative Chemoradiation: (6 weeks)

* 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42;
* Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6;
* Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.

Surgery at least 6 weeks after last day of aflibercept: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.

Postoperative Chemotherapy and Aflibercept Treatments (four 28-day cycles):

* Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle.
* Modified FOLFOX6:

  * Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.
  * Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.
  * 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle.

Interventions: intervention 1: Radiation intervention 2: Aflibercept intervention 3: Surgery intervention 4: FOLFOX6
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines intervention 4: None

Protocol document: