NCT03043729

mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer

mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer: a Randomized Phase-II-trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with MRI will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 + aflibercept (Arm B) followed by surgery.

Detailed description

Patients with locally advanced rectal cancer are generally recommended to receive preoperative radiotherapy or radiochemotherapy. The advantage of combined-modality therapy in rectal cancer is that it has reduced local pelvic recurrence - a dreaded and morbid event - to rates of about 10%. There is good quality evidence that preoperative radiotherapy reduces local recurrence but there is little if any impact on overall survival. One strategy to reduce the distant recurrence rate, and thereby increase the cure rate, would be to introduce systemic treatment earlier to prevent dissemination of micrometastases. The present trial is designed to compare two neoadjuvant chemotherapy regimens in patients with non-metastatic T3 CRM-negative rectal cancers using quality-controlled MRI of the pelvis as a main inclusion criterion. This strategy is believed to reduce acute and long-term toxicity caused by preoperative radiotherapy and to administer effective systemic chemotherapy early in the course of disease as neoadjuvant chemotherapy.

Conditions

• Rectal Cancer
• Rectosigmoid Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Oxaliplatin 85 mg/m\^2, as 2h infusion on Day 1 (Arm A + Arm B)
DRUG	5-FU	5-FU 400 mg/m\^2 i.v. as bolus on Day 1 and 2400 mg/m\^2 as 46 h infusion q2w (Arm A + Arm B)
DRUG	Leucovorin	Leucovorin 350 mg/m\^2 i.v. as 2h infusion on Day 1 (Arm A + Arm B)
BIOLOGICAL	Aflibercept	Aflibercept 4 mg/kg BW i.v. on Day 1 q2w (Arm B, Cycles 1 to 5)

Timeline

• Start date: 2017-03-06
• Primary completion: 2021-01-11
• Completion: 2022-06-01
• First posted: 2017-02-06
• Last updated: 2023-02-06

Locations

1 site across 1 country: Germany