Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a randomized phase II clinical trial
- Conditions
- soft tisssue sarcoma10010761sarcoma10027655
- Registration Number
- NL-OMON50770
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 168
• 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
• 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);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the short-term toxicity of 25 x 2 Gy, once daily fractionation<br /><br>in a five-week overall treatment time with respect to the rate of postoperative<br /><br>wound complications up to 30 days after surgery as compared to the wound<br /><br>complication rate up to 30 days after surgery preceded by 14 x 3 Gy in a three<br /><br>week OTT.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• to study the association between 14 x 3 Gy, once daily fractionation in a<br /><br>three-week overall treatment time and the local control.<br /><br>• to investigate the long-term toxicity of 14 x 3 Gy, once daily fractionation<br /><br>in a three-week overall treatment time and to report the percentage of<br /><br>fibrosis, edema, joint impairment and bone fractures scored by the Common<br /><br>Terminology Criteria for Adverse Events, CTCAE version 5.0, at 2 years<br /><br>follow-up.<br /><br><br /><br><br /><br>Exploratory endpoints<br /><br>• to investigate the health-related quality of life.<br /><br>• to investigate patient related outcomes (e.g. radiotherapy-related<br /><br>toxicities, health care consumption).<br /><br>• to investigate cost-effectiveness.</p><br>