Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity … (NCT00423618) | Clinical Trial Compass
CompletedPhase 3
Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma
United Kingdom216 participantsStarted 2006-03
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy to a smaller area of tissue surrounding the tumor is as effective as giving radiation therapy to a wider area of tissue surrounding the tumor in treating soft tissue sarcoma.
PURPOSE: This randomized phase III trial is studying giving external-beam radiation therapy to a small area of tissue surrounding the tumor to see how well it works compared with giving external-beam radiation therapy to a wider area of tissue surrounding the tumor in treating patients who have undergone surgery for soft tissue sarcoma of the arms, hands, legs, or feet.
Who can participate
Age range
16 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma meeting the following criteria:
* Lesion originates in extremity
* Upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
* No lesions of the chest wall arising adjacent to the scapula but not originating in the shoulder bone
* Lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
* Imaging and pathology from first surgery are required
* Has undergone surgical resection of the tumor within the past 12 weeks
* No macroscopic tumor in situ after surgery
* Microscopically irradical surgical margin allowed
* Excisional biopsy with positive margins or other inadequate surgery (macroscopically involved margins) allowed only after further definitive re-excision
* Positive margins and no further surgery possible except amputation or major functional loss allowed provided no macroscopic residual disease is present
* Local recurrence within 3 months of prior surgery (or other treatment) allowed provided patient undergoes subsequent re-excision
* No diagnosis of any of the following:
* Rhabdomyosarcoma (alveolar or embryonal)
* Primitive neuroectodermal tumor
* Soft tissue Ewing's sarcoma
* Extraskeletal osteosarcoma
* Aggressive fibromatosis (desmoid tumors)
* Dermatofibrosarcoma…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)
Timeframe: 2 years
2
Time to local recurrence
Timeframe: time from randomisation into the trial to the occasion when a local recurrence is confirmed by biopsy. For those patients who are not observed to have a local recurrence during the course of the study, the time to local recu
Trial details
NCT IDNCT00423618
SponsorSheffield Teaching Hospitals NHS Foundation Trust