Clinical trial · Interventional
Preoporative Bevacizumab, Radiation Therapy, and XELOX Chemotherapy for Locally Advanced Nonmetastatic Rectal Cancer
NCT01818973CI-TRIAL-00018179unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
We presumed that the addition of a monoclonal antibody Bevacizumab into radiation therapy and combination chemotherapy could results in improved pathologic tumor regression grade (TRG) in locally advanced nonmetastatic rectal cancer.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
| Xeloda | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Neoadjuvant chemotherapy with XELOX: Xeloda, po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning; Oxaliplatin, iv, 130mg/m2, day 1; and Bevacizumab, iv, 7.5 mg/kg, day 1, during the first cycle (each cycle has 3 weeks). Followed by chemoradiotherapy, 50 Gy/25 fractions during 5 weeks plus 2 cycles XELOX and Bevacizumab: Xeloda, po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning; Oxaliplatin, iv, 100mg/m2, day 1; and Bevacizumab, iv, 7.5 mg/kg, day 1. 6-7 weeks from the last radiation therapy, Total Mesorectal Excision (TME) surgery will be performed. 3-4 weeks after operation, 3 cycles XELOX (the same as the neoadjuvant chemotherapy) and 2 cycles Xeloda (po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning) will be administered.
- interventionNames
- Drug: Xeloda
- Drug: Oxaliplatin
- Drug: Bevacizumab
- Radiation: Radiation
- Procedure: surgery
Primary outcomes (1)
- measure
- The pathologic tumor regression grade (TRG)
- timeFrame
- March 30, 2015
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the colon or rectum. * T3 or T4 adenocarcinoma or node positive colorectal tumours. * Appropriate staging investigations of the primary tumour, either endorectal ultrasound or pelvic MRI. * Male or female aged 18 to 70. * Have a performance status ECOG of 0 or 1. * Have a life expectancy greater than 6 months. * Adequate organ function and coagulation parameters as measured by: WBC \> 4000/mm3, PLT \> 100000/mm3, Hb \> 10g/dL, ALT \< 1.5X ULN, AST \< 1.5X ULN, bilirubin \< 1.5mg/dL Serum creatinine \< 1.8mg/dL. * Patient consent. Exclusion Criteria: * Known to have clinical or radiological evidence of distant metastases. * Evidence of intestinal obstruction (except for those after enterostomy). * Patients with a past history of colorectal surgery (except for enterostomy), chemtherapy, radiation, biotherapy or targeted therapy. * Pregnant woman OR women of childbearing potential with a positive pregnancy test at baseline or lactating. * Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. * Patients with a past or current history (within last 5 years) of other malignancies, except for the indication under this study and curatively treated basal and squamous skin cancer or in-situ cancer of the cervix. * Patients with mental disorder unable to complete the informed consent. * Uncontrolled hypertension. * Clinically significant (i.e. active) cardiovascular disease for example: cerebrovascular accidents (\<=6 months), myocardial infarction (\<= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. * Moderate or serious proteinuria. * Known hypersensitivity against experimental drugs.
References
Publications (1)
- DERIVEDYu X, Wang QX, Xiao WW, Chang H, Zeng ZF, Lu ZH, Wu XJ, Chen G, Pan ZZ, Wan DS, Ding PR, Gao YH. Neoadjuvant oxaliplatin and capecitabine combined with bevacizumab plus radiotherapy for locally advanced rectal cancer: results of a single-institute phase II study. Cancer Commun (Lond). 2018 May 21;38(1):24. doi: 10.1186/s40880-018-0294-z. PMID 29784042