Randomized study of preoperative radiation and surgery or irradiation alone in the treatment of stage ib and IIA carcinoma of the uterine cervix: Preliminary analysis of failures and complications

A prospective randomized study in selected patients with Stage IB and IIA carcinoma of the uterine cervix was carried out at Washington University between January 1966 and December 1977. Patients were randomized to be treated with 1) irradiation alone consisting of 1000 rad whole pelvis, additional 4000 rads to the parametria with a step wedge midline block, and two intracavitary insertions for 7500 mgh; and 2) irradiation and surgery, consisting of 2000 rad whole pelvis irradiation, one intracavitary insertion for 5000–6000 mgh followed in two to six weeks later by a radical hysterectomy with pelvic lymphadenectomy. A total of 37 patients with Stage IB and 16 with Stage IIA were randomized to be treated with irradiation alone. A similar group of 41 patients with Stage IB and eight with IIA were randomized to the preoperative radiation and surgery group. The five‐year, tumor‐free actuarial survival for Stage IB patients treated with radiation was 87% and with preoperative radiation and surgery 82%. In Stage IIA, the actuarial five‐year survival NED was 57% for the irradiation alone group and 71% for the patients treated with preoperative radiation and radical hysterectomy. Analysis of the anatomical site of failure indicated that in the 37 patients with Stage IB treated by irradiation alone no pelvic failures occurred, and 4 patients developed distant metastasis. In the 41 patients treated with combined therapy, there were three pelvic failures (7.2%) and four distant metastasis. In the 16 patients with Stage IIA treated with radiotherapy alone, there were four pelvic failures (all parametrial), three of them combined with distant metastasis. In the 8 patients treated with irradiation and surgery, one developed a pelvic recurrence, and 1 distant metastasis. In the preoperative radiation group, the incidence of metastatic pelvic lymph nodes was 7.1% in Stage IB and 12.5% in Stage IIA. Major complications of therapy were slightly higher in the patients treated with radiation alone (9.4%, consisting of one rectovaginal fistula and one vesico‐vaginal fistula and a combined recto‐vesico‐vaginal fistula in another patient). In the preoperative radiation group, only two ureteral strictures (4.1%) were noted. The present study shows no significant difference in therapeutic results or morbidity for invasive carcinoma of the uterine cervix Stage IB or IIA treated with irradiation alone or combined with a radical hysterectomy.