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Prevention of wound complications with hyperbaric oxygen therapy for soft tissue sarcoma patients


- candidate number23962
- NTR NumberNTR5693
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-feb-2016
- Secondary IDsNL56437.078.16 
- Public TitlePrevention of wound complications with hyperbaric oxygen therapy for soft tissue sarcoma patients
- Scientific TitlePREVENTION OF WOUND COMPLICATIONS WITH HYPERBARIC OXYGEN THERAPY DURING PREOPERATIVE RADIOTHERAPY FOR PATIENTS WITH SOFT TISSUE SARCOMA: A PHASE II STUDY
- ACRONYMSHORT
- hypothesisOur hypothesis is that HBOT decreases the incidence of wound complications of surgery following preoperative radiotherapy. Added to this, increasing the oxygen level of irradiated tissue might have a positive effect on radiotherapy response.
- Healt Condition(s) or Problem(s) studiedSarcoma, Oxygen therapy
- Inclusion criteria- Patients 18 years old
- Tumor size of > 5 cm.
- Primary tumour site: extremity, trunk, groin, (excluding intra-abdominal and retroperitoneal sarcomas)
- WHO performance status 2
- Written informed consent
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Every patient has been discussed in the local tumor board.
- A MRI scan of the tumor not older than 6 weeks.
-CT thorax not older than 6 weeks.
- a resectable tumor according to the surgeon
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- Other malignancy with a life expectancy of less than 2 years.
- Prior radiotherapy to the local site
- Presence of metastases
- Chemotherapy needed for this sarcoma
- Patients with contraindications for hyperbaric oxygen therapy: Pneumothorax, TBC, COPD Gold IV, bullae, myocardial infarction, EF 30%, serious cardiac valve problems, acute ischaemic CVA, unstable epilepsy.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 2-apr-2016
- planned closingdate2-apr-2018
- Target number of participants41
- InterventionsHyperbaric Oxygen, 90 minutes per , 5 days per week, during the radiotherapy course (25 fractions)
- Primary outcomeThe primary objective will be the number, size and features of postoperative wound complications during the first 4 months after surgery
- Secondary outcome- the acute toxicity during radiotherapy with HBOT according to the to the Common Terminology Crtiteria for Adverse Events 4 (CTC-AE4).
- the tumor response will also be evaluated with a MRI 2 weeks before the surgery according to the RECIST criteria.
- the percentage of necrosis in the pathology specimen.
- TimepointsThe patients will be followed up weekly during the first month, and monthly thereafter up to 4 months after surgery.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. J.J. Nuyttens
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.J. Nuyttens
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD13-feb-2016 - 15-apr-2016


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