To assess whether preoperative radiotherapy, as an adjunct to curative-intent surgery, improves the abdominal local recurrence-free survival.
ID
Source
Brief title
Condition
- Soft tissue neoplasms malignant and unspecified
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
abdominal recurrence free survival
Secondary outcome
safety secondary endpoints:
- acute toxicity profile of preoperative radiotherapy
- perioperative complications
- late complications
efficacy secondary endpoints:
- tumor response
- time to abdominal recurrence
- metastasis-free survival
- overall survival
Background summary
Approximately 10-15% of adult soft tissue sarcomas arise in the
retroperitoneum. The mean annual incidence is 2.7 cases per 10^6 persons and
does not change significantly over time. The sex ratio is approximately 1, and
the mean age is 55. The most frequent histological subtypes are:
well-differentiated liposarcomas, dedifferentiated liposarcomas and
leiomyosarcomas.
RPS are marked by a poor outcome, especially over the long term. The 5-year
overall survival rate is 50-60%, significantly worse than soft tissue arising
from the extremity. The poor outcome is not explained by the occurence of
metastases but by local recurrence.
Study objective
To assess whether preoperative radiotherapy, as an adjunct to curative-intent
surgery, improves the abdominal local recurrence-free survival.
Study design
Patient with histological proven RPS will be randomized between preoperative
radiotherapy followed by surgery or surgery alone.
Intervention
Pre-operative radiotherapy with a dose of 50.4Gy in 28 fractions of 1.8Gy
Study burden and risks
The psychological burden caused by taking part of the clinical trial and also
the possibility of more toxicity because of the radiotherapy, mainly
gastro-intestinal toxicity, renal damage, hepatic damage and secundairy
malignancies. Twenty-eight irradiation fractions will cause some physical
distress.
Avenue E. Mournier 83,bte 11
Brussel 1200
BE
Avenue E. Mournier 83,bte 11
Brussel 1200
BE
Listed location countries
Age
Inclusion criteria
*18 years old
WHO performance status * 2 (see Appendix C)
Primary untreated soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis
Unifocal tumor
Histologically-proven RPS, see also exclusion criteria
Tumor both operable and suitable for radiotherapy (anticipated macroscopically complete resection, R0/R1 resection)
Patients must have American Society of Anesthesiologist (ASA) score * 2 (see Appendix G)
Normal renal function: Calculated creatinine clearance within normal value (calculated by Cockcroft-Gault; see Appendix E)
Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram (done during the baseline CT-scan) or differential renal isotope scan
Normal bone marrow and hepatic function:
* White Blood cells * 2.5 x10 9 cells/L
* Platelets * 80 x10 9 cells/L
* Total bilirubin < 1.5 time the institutional upper limit normal of value (ULN)
Adequate cardiac function: less or equal to NYHA II (see Appendix D)
Normal 12 lead ECG (without clinically significant abnormalities)
Written informed consent
Exclusion criteria
Sarcoma originating from bone structure, abdominal or gynecological viscera
Multifocal disease or metastatic disease
Extension through the sciatic notch or across the diaphragm
The following diagnoses are excluded:
* Gastro-intestinal stromal tumor (GIST)
* Rhabdomyosarcomas
* PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma,
* aggressive fibromatosis
* sarcomatoid or metastatic carcinoma
Expected R2 resection
History of bowel obstruction or mesenteric ischemia or severe chronic inflammatory bowel disease
Pregnancy or breast feeding state (Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and for at least 1 month after the surgery)
Co-existing malignancy within the last 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
Prior abdominal or pelvic irradiation for other prior malignancy or other disease
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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 |
|---|---|
| ClinicalTrials.gov | NCT01344018 |
| CCMO | NL37929.031.11 |