Phase 2
N=84
Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00828672 ↗Enrolled (actual)
84
Serious AEs
39.3%
Results posted
Jul 2019
Primary outcome: Primary: Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery. — 34; 11; 41; 24 percentage of cases
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxaliplatin (Drug); Bevacizumab (Drug); Capecitabine (Drug); radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery. |
34; 11; 41; 24; 59; 76 | — |
| SECONDARY Number of Participants With Histopathologic R0 and Negative CRM Resection |
40; 37; 1; 2 | — |
| SECONDARY Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery. |
14; 4; 17; 9; 24; 29 | — |
| SECONDARY Clinical Response Rate |
3; 5; 24; 17; 9; 13 | — |
| SECONDARY Types and Numbers of Adverse Events - General Overview |
22; 12; 564; 426; 27; 16 | — |
| SECONDARY Recurrence Rates and Disease Free Survival |
9; 9; 33; 32; 1; 0 | — |
| SECONDARY Death Rates and Overall Survival |
6; 7; 36; 34; 1; 0 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00828672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.