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Bevacizumab modulation of telangiectasia in irradiated rectal cancer patients.

Bevacizumab modulation of telangiectasia.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22711
Enrollment
20
Registered
2011-12-14
Start date
2011-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer bevacizumab telangiectasia radiotherapy

Interventions

2 sigmoidoscopies for mucosal biopsy sampling.

Sponsors

NKI-AVL (Netherlands ancer Institute)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients, diagnosed with local tumor residue / recurrence or metastasis, 6 months or longer after the start of their initial pre-operative radiotherapy or chemo-radio therapy (CRT) and will now be treated with bevacizumab; 2. Rectal endoscopy is possible; 3. Aged over 18 years; 4. Written informed consent is provided.

Exclusion criteria

Exclusion criteria: 1. Previous abdomino-perineal resection (APR) (no endoscopic access); 2. Anastomotic bleeding, leakage or breakdown at study enrolment; 3. Use of anticoagulants or anti aggregants.

Design outcomes

Primary

MeasureTime frame
The primary end-point of this study will be the number and size of teleangiectasia encountered, lymph vessel morphology and immunohistochemical evaluation of inflammation and vessel maturation.

Secondary

MeasureTime frame
The secondary endpoint will be the number of complications following bevacizumab treatment and or endoscopic procedures: Rates of anastomotic leakage or breakdown, rectal ulcer or bleeding.

Contacts

Public ContactS. Vanhoutvin

Netherlands Cancer Institute Dept of Biometrics

s.vanhoutvin@nki.nl+31 (0)20 5127496

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)