Health TrialsbyHealthPanel

Surgical Timing After Preoperative Hypofractionated Radiotherapy for Localized Extremity and Trunk Soft Tissue Sarcoma

ConditionSoft Tissue Sarcoma of the Trunk and Extremities
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorItalian Sarcoma Group

About this trial

Phase II, national, multicentric, prospective, randomized (1:1) non-inferiority trial with two parallel groups, incorporating a concurrent observational cohort of eligible non-randomized patients, designed to address critical knowledge gaps by prospectively evaluating the safety, efficacy, and feasibility of preoperative ultra-hypofractionated radiotherapy (HFRT) in patients with soft tissue sarcomas (STS) of the extremities and trunk.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary written informed consent, with the ability to fully understand and effectively communicate, before performance of any study-related procedure not part of normal medical practice, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Age > 18 years

Proven diagnosis of primary, resectable extremity/trunk wall STS with low-medium risk (Sarculator© predicted 10y-OS > 60%)

Measurable disease criteria (RECIST 1.1 and CHOI)

Disqualifiers

Age < 18y

Soft tissue sarcomas (STS) originating at different sites (i.e., retroperitoneal, abdominal, pelvic, head and neck), gynecological sarcomas, as well as gastrointestinal stromal tumors (GISTs), desmoid-type fibromatosis and pediatric-type sarcomas (i.e., extraosseous Ewing sarcoma, embryonal/alveolar rhabdomyosarcoma, desmoplastic small round cell tumor) are excluded.

Recurrent or metastatic condition or previous whoop-surgery for sarcoma (incisional biopsies are allowed if performed 6 months before referral).

Unresectable tumors (with limb sparing surgery)

Trial design

Design model

Sequential

Treatments tested in this trial

  • hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment

    Procedure/Surgery

    hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment

  • hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment

    Procedure/Surgery

    hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment

Treatment groups

142 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Observational cohortNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Determine the incidence of postoperative complications

The primary objective of this study is to determine the incidence of postoperative complications (according to Clavien-Dindo) within 90 days from surgery

Time frame
Day of surgery (DOS); 7-14-21-30-60-90 days post DOS; 4-8-12-16-20-24 months post DOS

Secondary outcomes

1

Quality of Life (QoL)

Quality of Life (QoL)

Time frame
At last available QoL assessment date for patients without confirmed deterioration
2

Overall Survival (OS)

Overall Survival (OS)

Time frame
At the last date that patient was known to be alive
3

Disease-Free Survival (DFS)

Disease-Free Survival (DFS)

Time frame
Months 4-8-12-16-20-24 post surgery
4

Cumulative Incidence of Local Recurrence (CCI-LR)

Cumulative Incidence of Local Recurrence (CCI-LR)

Time frame
Months 4-8-12-16-20-24 post surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Italian Sarcoma Group

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: