|- candidate number||23962|
|- NTR Number||NTR5693|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-feb-2016|
|- Secondary IDs||NL56437.078.16 |
|- Public Title||Prevention of wound complications with hyperbaric oxygen therapy for soft
tissue sarcoma patients|
|- Scientific Title||PREVENTION OF WOUND COMPLICATIONS WITH HYPERBARIC OXYGEN
THERAPY DURING PREOPERATIVE RADIOTHERAPY FOR PATIENTS WITH
SOFT TISSUE SARCOMA: A PHASE II STUDY|
|- hypothesis||Our 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) studied||Sarcoma, Oxygen therapy|
|- Inclusion criteria||- Patients ¡Ý 18 years old|
- Tumor size of > 5 cm.
- Primary tumour site: extremity, trunk, groin, (excluding intra-abdominal and retroperitoneal sarcomas)
- WHO performance status ¡Ü 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 criteria||A 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 received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||2-apr-2016|
|- planned closingdate||2-apr-2018|
|- Target number of participants||41|
|- Interventions||Hyperbaric Oxygen, 90 minutes per , 5 days per week, during the radiotherapy course (25 fractions)|
|- Primary outcome||The 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.
|- Timepoints||The patients will be followed up weekly during the first month, and monthly thereafter up to 4 months after surgery.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. J.J. Nuyttens|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. J.J. Nuyttens|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||13-feb-2016 - 15-apr-2016|