Condition category
Cancer
Date applied
14/04/2008
Date assigned
09/05/2008
Last edited
09/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jürgen Dunst

ORCID ID

Contact details

Universitätsklinikum Schleswig-Holstein
Campus Lübeck
Ratzeburger Allee 160
Lübeck
23538
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Final 01/12.11.07

Study information

Scientific title

Phase II trial: Pre-operative, long-term chemoradiation with capecitabine, oxaliplatin and bevacizumab in locally advanced rectal cancer

Acronym

BevXelOx-RT

Study hypothesis

Efficacy of neoadjuvant radio-chemotherapy will be improved by an additional angiogenesis-inhibiting therapy using the vascular endothelial growth factor (VEGF) antibody bevacizumab.

Ethics approval

Ethics Committee of the Medical Faculty, University of Lübeck. Date of approval: 26/02/2008

Study design

Open-label, single-arm, non-randomised, phase II study.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Locally advanced rectal cancer

Intervention

All participants will receive the following (single-arm study):
1. Radiotherapy: 5 × weekly 1.8 Gy to a total dose of 50.4 Gy
2. Chemotherapy: Capecitabine 1,650 mg/sqm orally (p.o.), (divided in 2 single doses) daily on days 1-14 and 22-35; oxaliplatin 50 mg/sqm intravenously (i.v.) on days 1, 8, 22, 29 over a 120-min infusion with 500 ml 5% glucose; bevacizumab 5 mg/kg i.v. as short time infusion (30-90 min) prior to oxaliplatin administration on days 1, 15, 29.

Intervention type

Drug

Phase

Phase II

Drug names

Capecitabine, oxaliplatin, bevacizumab.

Primary outcome measures

Histopathological complete remission rate at time of surgery (approximately 4 weeks following study treatment)

Secondary outcome measures

1. Pathological downstaging at time of surgery (approximately 4 weeks following study treatment)
2. Regression grading (according to Dvorak) at time of surgery (approximately 4 weeks following study treatment)
3. Sphincter preservation at time of surgery (approximately 4 weeks following study treatment)
4. Acute and subacute toxicity during study treatment, especially:
4.1. (Post)operative complications
4.2. Gastrointestinal perforation
4.3. Wound healing complications
4.4. Bleeding complications

Overall trial start date

01/05/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years, both males and females
2. Patients with histologically proven adenocarcinoma of the rectum, tumour = 16 cm from the anal verge, u T3-4 or uN+ or Mason III/IV, staging will must be done by endorectal ultrasound and magnetic resonance imaging (MRI) or by endorectal unltrasound and high resolution computed tomography, no evidence of metastatic disease
3. No prior treatment, except for ileostomy (if necessary due to ileus)
4. No fistulas near the tumour
5. Eastern Cooperative Oncology Group (ECOG) Performance Status <= 1
6. Adequate bone marrow, hepatic and renal function:
6.1. Haemoglobin >10.0 g/dL, leucocyte count > 3.5 x 109/L, absolute neutrophil count >1.5 x 109/L, platelet count >100 x 109/L
6.2. Alkaline phosphatase, alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) <3 x upper limit of normal (ULN)
6.3. Total bilirubin <= 2 mg/dL
6.4. Creatinine clearance >50 mL/min
6.5. Creatinine <= 1.5 x ULN
7. Patients must have understood the contents of the protocol and signed written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

68

Participant exclusion criteria

1. No presence of adequate contraception in fertile patients
2. Pregnant or breastfeeding women
3. Previous or persistent alcohol or drug abuses
4. Prior radiotherapy or chemotherapy to the pelvis, for any reason
5. Treatment with any investigational drug, agent nor procedure, (i.e. did not participate in another trial) within 4 weeks before entry in this trial
6. Treatment with other anti-cancer agents
7. Patients not able or willing to comply with the protocol treatment and investigations
8. Patients with uncontrolled severe somatic or psychological diseases, e.g.:
8.1. Despite medication uncontrolled cardiac diseases, myocardial infarction within the last 6 months prior to enrolment
8.2. Neurological or psychiatric disorders including seizures and dementia
8.3. Active, uncontrolled infection and sepsis
9. Symptomatic peripheral neuropathy >= grade 2 (National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI CTCAE])
10. Concurrent malignancies, with the exception of successfully treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the skin
11. Chronic diarrhoea > grade 1 (NCI CTCAE)
12. Chronic inflammatory bowel disease or other pre-existing condition which would deter resorption of drugs (e.g. dumping syndrome, evidence of accelerated small bowel passage, evidence of deterred resorption due to gastric or bowel surgery)
13. Known hypersensitivity to platinum-containing drugs
14. Concurrent use of the antiviral agent sorivudine or chemically related analogues
15. Known dihydropyrimidine dehydrogenase deficiency
16. Known allergy to any of the study drugs or its ingredients
17. Interstitial pneumonia or extensive, symptomatic lung fibrosis
18. Organ allograft requiring immunosuppressive therapy
19. Severe, non-healing wounds, ulcers or fractures
20. Thrombosis or severe bleeding (except for bleeding of the tumour) within 6 months prior to enrolment
21. Bleeding diathesis or thrombophilia
22. Therapeutic anticoagulation (with marcumar or heparin)
23. Acetylsalicylic acid >325 mg per day or routine use of non-steroidal anti-inflammatory drugs which inhibit the function of platelets
24. Ascites nescessitating puncture
25. Patients with proteinuria >= 1+ at baseline, as long as a 24–hour urine collection demonstrates >500 mg of protein/ 24 hr
26. Concurrent treatment with St. John's wort
27. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the preoperative chemoradiation (exceptions: protective ileostomy and the planned resection of the rectal cancer)

Recruitment start date

01/05/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsklinikum Schleswig-Holstein
Lübeck
23538
Germany

Sponsor information

Organisation

University Medical Centre Schleswig-Holstein (Universitätsklinikum Schleswig-Holstein) (Germany)

Sponsor details

Campus Lübeck
Ratzeburger Allee 160
Lübeck
23538
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.uk-sh.de

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Schleswig-Holstein (Universitätsklinikum Schleswig-Holstein) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Roche Pharma AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes