Phase 2
N=91
A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00865189 ↗Enrolled (actual)
91
Serious AEs
42.9%
Results posted
Aug 2017
Primary outcome: Primary: Percentage of Participants With Tumor Sterilization Defined by ypT0-N0 — 23.8; 11.4 percentage of participants — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug); Oxaliplatin (Drug); Folinic Acid (Drug); 5-fluorouracil (Drug); Preoperative Radiotherapy (Radiation); Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Tumor Sterilization Defined by ypT0-N0 |
23.8; 11.4 | 0.015 sig |
| SECONDARY Percentage of Participants With Tumor Down-Staging (ypT0-pT2) |
65.9; 54.5; 64.1; 55.8 | — |
| SECONDARY Percentage of Participants With Local and Distant Recurrences |
2.2; 6.7; 17.4; 13.3 | — |
| SECONDARY Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death |
30.4; 33.3 | — |
| SECONDARY Disease-Free Survival (DFS) |
68.3; NA | — |
| SECONDARY Percentage of Participants Who Died |
8.7; 24.4 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Number of Cycles of Induction Chemotherapy |
5.8 | — |
| SECONDARY Number of Cycles of Chemotherapy |
4.4; 4.8 | — |
| SECONDARY Number of Cycles of Radiotherapy |
4.5; 5.0 | — |
| SECONDARY Percentage of Participants With Surgery |
91.3; 97.8 | — |
Summary
This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).
Eligibility Criteria
Inclusion Criteria
- histologically confirmed locally advanced rectal cancer;
- measurable disease;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Exclusion Criteria
- prior treatment with bevacizumab;
- prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
- previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
- history or evidence of central nervous system (CNS) disease;
- clinically significant cardiovascular disease;
- chronic treatment with high dose aspirin (more than [>] 325 milligrams per day [mg/day]) or non-steroidal anti-inflammatory drugs.
Data sourced from ClinicalTrials.gov (NCT00865189). 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.