No registrations found.
ID
Source
Brief title
Health condition
sarcoma, hyperbaric oxygen, preoperative radiotherapy
Sponsors and support
Intervention
Outcome measures
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.
Study objective
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.
Study design
The patients will be followed up weekly during the first month, and monthly thereafter up to 4 months after surgery.
Intervention
Hyperbaric Oxygen, 90 minutes per , 5 days per week, during the radiotherapy course (25 fractions)
Erasmus MC, Daniel den Hoed,
Groenehilledijk 301,
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041766
j.nuyttens@erasmusmc.nl
Erasmus MC, Daniel den Hoed,
Groenehilledijk 301,
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041766
j.nuyttens@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5571 |
| NTR-old | NTR5693 |
| CCMO | NL56437.078.16 |