We conducted a prospective trial to define the local recurrence rates for selected patients with T1 soft tissue sarcomas (STS) treated by surgery alone.

Retrospective data suggest that some patients with small STS can be safely treated by surgery alone. There are no defined criteria to select patients for such treatment.

Patients with T1 primary STS were treated with function-preserving surgery and microscopic assessment of surgical margins. Postoperative external-beam radiation was employed selectively for patients with microscopically positive (R1) final surgical margins. Patients who underwent resection with microscopically negative (R0) final margins did not receive radiotherapy.

Eighty-eight eligible and evaluable patients were entered on this protocol between March 1996 and April 2002. Tumor sites included the extremities (n=60), and trunk (n=26). Fifty-one patients (58%) had high-grade STS; 60 (68%) had superficial (T1a) disease. Fourteen patients (16%) underwent R1 resection and were treated with postoperative radiation; 74 (84%) underwent R0 resection and were treated by surgery alone. The median follow-up was 75 months. Isolated local recurrences were observed in 11 patients (13%; 6 in R1 arm, 5 in R0 arm). In the R0 surgery-alone arm, the cumulative incidence rates of local recurrence at 5 and 10 years were 7.9% and 10.6%, respectively; and the 5- and 10-year sarcoma-specific death rates were 3.2% and 3.2%.

Selected patients with primary T1 STS of the extremity and trunk can be treated by R0 surgery alone with acceptable local control and excellent long-term survival.