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.
ID
Bron
Verkorte titel
Aandoening
sarcoma, hyperbaric oxygen, preoperative radiotherapy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary objective will be the number, size and features of postoperative wound complications during the first 4 months after surgery
Doel van het onderzoek
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.
Onderzoeksopzet
The patients will be followed up weekly during the first month, and monthly thereafter up to 4 months after surgery.
Onderzoeksproduct en/of interventie
Hyperbaric Oxygen, 90 minutes per , 5 days per week, during the radiotherapy course (25 fractions)
Publiek
Erasmus MC, Daniel den Hoed,
Groenehilledijk 301,
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041766
j.nuyttens@erasmusmc.nl
Wetenschappelijk
Erasmus MC, Daniel den Hoed,
Groenehilledijk 301,
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041766
j.nuyttens@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5571 |
| NTR-old | NTR5693 |
| CCMO | NL56437.078.16 |