search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The effectiveness of the placement of gold markers for irradiation of rectal cancer.


- candidate number17937
- NTR NumberNTR4606
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mei-2014
- Secondary IDsNL46483.031.14 
- Public TitleThe effectiveness of the placement of gold markers for irradiation of rectal cancer.
- Scientific TitlePilot study evaluating the feasibility of endoscopy guided fiducial marker placement for rectal cancer.
- ACRONYMRemark
- hypothesisThe aim of this study is to evaluate the feasibility of endoscopic guided placement of gold markers in rectal cancer patients.
An effective and safe endoscopic placement of fiducial markers in the rectum may benefit the imaging of the rectal tumor for radiotherapy purposes (position verification and target volume delineation).
- Healt Condition(s) or Problem(s) studiedRectal cancer, Radiation
- Inclusion criteria Histologically proven diagnosis of primary rectal adenocarcinoma
Resectable rectal cancer
o cT1-3N1 / cT3N0 with extramural invasion >5 mm
o Distance to mesorectal fascia >1 mm
No evidence of distant metastasis
Treatment plan: 5 x 5 Gray (Gy) neoadjuvant radiotherapy followed by TME
Written informed consent
- Exclusion criteria Coagulopathy (prothrombin time < 50% of control; partial thromboplastin time > 50 seconds) or anticoagulantia (marcoumar or sintrom) that cannot be stopped
Prior pelvic irradiation or surgery
World health organization performance status 3-4
Pregnant women
Patients who underwent a hip replacement
Patients with a contraindication for MRI (e.g. pacemaker, metallic foreign body in the eye, cerebral aneurysm clips, claustrophobia)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2014
- planned closingdate1-dec-2014
- Target number of participants20
- InterventionsPatients will undergo an (endoscopic ultrasound (EUS) guided) endoscopy during which two to three gold markers will be inserted in the upper and lower border of the tumour and in the center of the tumour.
Five additional cone beam CT scans and one or two additional MRI scans will be made for evaluation of the fiducial markers.
- Primary outcomeThe feasibility of fiducial marker placement, defined as the technical success (the ability to successfully place the fiducials at the desired locations in the tumour area).
- Secondary outcome- Patient safety: grade 3-4 complications (NCI-CTCAE version 4.0) or symptoms lasting more than two days.
- Visibility of fiducial markers on MRI and CT
- Migration of fiducial markers
- TimepointsThe study participation of the patient will end after the TME.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES M.E. Leerdam, van
- CONTACT for SCIENTIFIC QUERIES M.E. Leerdam, van
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL)
- Publications
- Brief summary
- Main changes (audit trail)Inclusion NEW: 4-apr-2016-EB

Histologically proven diagnosis of primary rectal adenocarcinoma
Treatment options:
 5 x 5 Gray (Gy) neoadjuvant radiotherapy followed by TME
 Chemoradiation consisting of 25 x 1,8 Gy combined with Capecitabine 825 mg/m2 twice daily followed by TME
 5x5 Gy RT followed by chemotherapy (with or without a subsequent TME)
Written informed consent
- RECORD23-mei-2014 - 29-sep-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl