Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer (AXEBEAM)

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 2

Conditions: Locally Advanced Rectal Cancer

Treatments: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: radiotherapy; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00828672

MO19051 (Other Grant/Funding Number)

2007-007177-23 (EudraCT Number)

s51104 - ML5194

Details and patient eligibility

About

Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.

To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

Full description

See Synopsis

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adenocarcinoma of rectum measurable (RECIST), locally advanced (defined by MRI - Tumour beyond mesorectal fascia (T4) or Tumour ≤ 2 mm from mesorectal fascia or T3 tumour < 5 cm from anal verge
• Patient is at least 18 years of age
• Good organ function

Exclusion criteria

• Evidence of distant metastases
• Contraindication for bevacizumab
• Pregnant or breastfeeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

AXE (ARM 1)

Active Comparator group

Description:

Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.

Treatment:

Drug: Bevacizumab

Radiation: radiotherapy

Drug: Capecitabine

Drug: Oxaliplatin

AX (ARM 2)

Active Comparator group

Description:

Bevacizumab and Capecitabine concurrently with radiotherapy

Treatment:

Drug: Bevacizumab

Radiation: radiotherapy

Drug: Capecitabine