The OPTIMAL-PORT study aims to demonstrate the non-inferiority of *surgery only* compared to surgery with adjuvant radiotherapy as treatment for impending and actual pathological fractures on the pain experienced by patients.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is patient reported pain according to a numeric rating scale
(NRS).
Secondary outcome
Clinical functioning, radiological status, complications (including revisions)
and survival are secondary endpoints.
Background summary
Bone metastases arise in 50% of all patients diagnosed with carcinoma,
increasing up to 70% in patients with breast and prostate cancer. The lesions
can cause pain and fractures, leading to diminished quality of life and poorer
survival. Current knowledge concerning adequate, personalized treatment of
metastatic lesions of the long bones in patients with disseminated cancer is
insufficient and inconclusive due to lack of large, prospective series with
patient reported outcome measures. One of the debatable issues is the
effectiveness of postoperative radiotherapy. It has become common practise due
to professional opinion, but research evidence is lacking. It is thought that
adjuvant radiotherapy improves the durability of an implant, prevents
progression of the lesion, promotes bone healing, improves limb function,
minimises pain and reduces the need for reoperations, however none of these are
certain. Moreover, it is a burden on patient's quality of life (e.g. multiple
extra hospital visits) causing toxicity and possible side effects (e.g. skin
irritation). The true beneficial effect, weighing up the possible pros and
certain cons, of adjuvant radiotherapy is thus unknown.
Study objective
The OPTIMAL-PORT study aims to demonstrate the non-inferiority of *surgery
only* compared to surgery with adjuvant radiotherapy as treatment for impending
and actual pathological fractures on the pain experienced by patients.
Study design
A multicentre, prospective, randomised non-inferiority trial nested within the
OPTIMAL study.
Intervention
One study group (A) will receive surgery only; the other study group (B) will
receive surgery with adjuvant radiotherapy.
Study burden and risks
Patients participating in the PORT study will perhaps not directly benefit from
their participation. Due to the fact that there is still much uncertainty
concerning the necessity of post-operative radiotherapy for quality of life, it
is possible that there is benefit in either group. Participation will in any
case contribute to deriving patient-specific treatment modalities for future
patients with bone metastases of the long bones. Risks associated with
participation are related to the local consequences of (lack of) radiotherapy
and to the quality of life.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Aged 18 or older
- Receive surgical treatment (prosthesis, intramedullary nail, plate, curettage with/without cement) with palliative intent for a pathologic fracture or impending pathologic fracture of the extremities (humerus/femur and further distal) due to metastatic bone disease
- Radiographic or histologic proof of metastatic bone disease
- Histologic diagnosis of the primary tumour or * if the diagnosis is unknown - at least adequate diagnostic investigations into the origin of the metastasis (e.g. dissemination imaging, histology, biopsy)
Exclusion criteria
- Communication with patient is hampered (e.g. language barrier, severe cognitive impairment, dementia)
- The treated lesion originates from multiple myeloma, solitary plasmacytoma or lymphoma of bone
- Further radiotherapy is considered inappropriate (> 2 series RT on current lesion)
- Physically unable to undergo post-operative RT treatment, according to treating doctor*s opinion
- Absolute need for post-operative treatment with radiotherapy, specify reason:
o Pain
o Extent of bone lesion (outside surgical field)
o Soft tissue involvement
o Curative intent of treatment
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL54480.058.15 |