Clinical trial · Interventional
Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma
Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- Radiotherapy Conventional treatment arm A total of 33 fractions each of 2Gy should be given once a day for 5 days per week over 6 weeks and 3 days in week 7, totalling 66Gy. The first 50 Gy in 25 fractions will be given to CTV1 and subsequent 16 Gy in 8 fractions will be delivered to CTV2.
- interventionNames
- Radiation: radiotherapy
- type
- EXPERIMENTAL
- label
- Research arm
- description
- Radiotherapy Research arm A total of 33 fractions each of 2Gy should be given once a day for 5 days per week over 6 weeks and 3 days in week 7, totalling 66Gy. The 66Gy in 33 fractions will be delivered to CTV2 alone. No attempt will be made to include drain/biopsy sites or the surgical scar.
- interventionNames
- Radiation: radiotherapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 protuberans
* Gorlin's syndrome
* No regional nodal disease or unequivocal distant metastasis
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No other major medical illness that would preclude study treatment
* No other malignancy except adequately treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy to the local site
* No prior neoadjuvant or adjuvant chemotherapyReferences
Publications (1)
- DERIVEDSimoes R, Gulliford S, Seddon B, Dehbi HM, Robinson M, Forsyth S, Hughes A, Gaunt P, Nguyen TG, Elston S, Mohammed K, Zaidi S, Miles E, Hoskin P, Harrington K, Miah A. Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) using dose-volume constraints development: a study protocol. BMJ Open. 2024 Aug 9;14(8):e083617. doi: 10.1136/bmjopen-2023-083617. PMID 39122389