Clinical trial · Interventional
Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer
A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- AXE (ARM 1)
- description
- Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
- interventionNames
- Drug: Oxaliplatin
- Drug: Bevacizumab
- Drug: Capecitabine
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- AX (ARM 2)
- description
- Bevacizumab and Capecitabine concurrently with radiotherapy
- interventionNames
- Drug: Bevacizumab
- Drug: Capecitabine
- Radiation: radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available