to compare the short-term toxicity of the conventional schedule of 25 x 2 Gy, once daily fractionation in a five-week Overall Treatment Time (OTT) to 14 x 3 Gy, once daily fractionation in a three-week OTT, with respect to the rate of postoperative…
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the short-term toxicity of 25 x 2 Gy, once daily fractionation
in a five-week overall treatment time with respect to the rate of postoperative
wound complications up to 30 days after surgery as compared to the wound
complication rate up to 30 days after surgery preceded by 14 x 3 Gy in a three
week OTT.
Secondary outcome
• to study the association between 14 x 3 Gy, once daily fractionation in a
three-week overall treatment time and the local control.
• to investigate the long-term toxicity of 14 x 3 Gy, once daily fractionation
in a three-week overall treatment time and to report the percentage of
fibrosis, edema, joint impairment and bone fractures scored by the Common
Terminology Criteria for Adverse Events, CTCAE version 5.0, at 2 years
follow-up.
Exploratory endpoints
• to investigate the health-related quality of life.
• to investigate patient related outcomes (e.g. radiotherapy-related
toxicities, health care consumption).
• to investigate cost-effectiveness.
Background summary
Currently, soft tissue sarcomas (STS) are preoperatively irradiated in a
conventionally fractionated regimen of 25 x 2 Gy in five weeks. Recent
radiobiological investigations, however, suggest sensitivity to (modest)
hypofractionation. Within this study, patients will be randomized to receive
either the conventional schedule of 25 x 2 Gy or a shorter preoperative regimen
of 14 x 3 Gy, in the hypothesis that both the postoperative wound complication
rate until 30 days after surgery, as well as the local control probability at
two years are comparable in both arms
Study objective
to compare the short-term toxicity of the conventional schedule of 25 x 2 Gy,
once daily fractionation in a five-week Overall Treatment Time (OTT) to 14 x 3
Gy, once daily fractionation in a three-week OTT, with respect to the rate of
postoperative wound complications up to 30 days after surgery
Study design
A prospective randomized phase II clinical study
Intervention
radiotherapy
Arm A: 25 x 2 Gy with an overall treatment time of 5 weeks
Arm B; 14 x 3 Gy with an overall treatment time of 3 weeks
Study burden and risks
The study aims to reduce the treatment burden for sarcoma patients by a
reduction of the number of radiation fractions and thereby patients visits to
the hospital. It is hypothesized that a reduction of treatment burden will not
be associated with a wound complication rate higher than 42% and will result in
a benefit with respect to quality of life for participating patients
All patients have to fill out a Health related questionnaires 9 times.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
• Histologically confirmed newly diagnosed intermediate to high grade soft
tissue sarcoma localized to thethe head and neck area, trunk or chest wall or
extremities, for which the standard treatment is a combination of and
radiotherapy and surgery (deep seated and/or >= 5cm in largest tumor diameter
and/or an anticipated close resection margin and/or grade II/III according to
the FNCLCC definition);
• Absence of regional and/or distant disease. Patients must be staged by at
least a CT scan of the chest Staging may also be performed by FDG-PET scanning
and or total body MRI scans. Patients with an uncertain metastatic status (e.g.
small indifferent lung nodules) and patients with a low metastatic burden not
precluding the application of both preoperative radiotherapy and definitive
surgery, are allowed to participate;
• WHO Performance Status <= 2;
• Able and willing to undergo preoperative radiotherapy;
• Able and willing to undergo definitive surgery;
• Able and willing to comply with regular follow-up visits;
• Able and willing to complete patient reported outcome questionnaires
(health-related quality of life and cost effectiveness);
• Able and willing to undergo randomization;
• Age >= 18 years;
• Signed written informed consent
Exclusion criteria
• Prior malignancies; except another malignancy and disease-free for >= 5 years,
or completely resected non-melanomatous skin carcinoma or successfully treated
in situ carcinoma;
• Patients with recurrent sarcomas who underwent prior radiotherapy to the
target lesion (if the primary sarcoma was managed by surgery only and no
perioperative RT, patients are eligible);
• Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric
and adult), osteosarcomas;
• 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;
• Female patients who are pregnant;
• Intention to perform an isolated limb perfusion, instead of a tumor resection;
• Neoadjuvant chemotherapy to be scheduled between end of radiotherapy and
definitive surgery (neoadjuvant chemotherapy before radiotherapy is allowed);
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT04425967 |
| CCMO | NL75757.031.20 |