Postoperative external pelvic irradiation after vaginal radium in stage I endometrial carcinoma (Aalders trial)
N = 540
- Population
- Stage I adenocarcinoma of the corpus uteri after primary surgery
- Design
- Prospective clinical trial, 1968 to 1974, 540 patients with stage I adenocarcinoma of the corpus uteri. After primary surgery all patients received intravaginal radium (6000 rads to the surface of the vaginal mucosa). At the time vaginal radium was given they were randomised to no further treatment (group A) or additional high-voltage pelvic irradiation (4000 rads to the pelvic lymph nodes, group B). Follow-up 3 to 10 years. The abstract does not state phase, primary endpoint or group sizes.
- Arms
- Vaginal radium alone (group A) (control): Intravaginal radium after surgery, no further treatment
- Vaginal radium plus pelvic irradiation (group B) (experimental): Intravaginal radium after surgery plus external pelvic irradiation (4000 rads to the pelvic lymph nodes)
- People
- Aalders J
Δ Vaginal and pelvic recurrence−5 pointsΔ Distant metastasis+4.5 points
Show the numbers
| Endpoint | Analysis | Vaginal radium plus pelvic irradiation (group B) | Vaginal radium alone (group A) | Effect |
|---|---|---|---|---|
| Vaginal and pelvic recurrencePatients entered on the trial (540)Proportion of patients with vaginal or pelvic recurrence over follow-up of 3 to 10 years; no fixed time point in the abstract | finalAalders 1980 | 1.9% | 6.9% | P<.01 |
| Distant metastasisPatients entered on the trial (540)Proportion of patients who developed distant metastases over follow-up of 3 to 10 years; the abstract gives no p-value | finalAalders 1980 | 9.9% | 5.4% | The abstract states that the 5-year survival rate was not improved by external irradiation (no figures given). |
| Endpoint | Analysis | Vaginal radium plus pelvic irradiation (group B) | Vaginal radium alone (group A) | Effect |
|---|---|---|---|---|
| Vaginal and pelvic recurrencePatients entered on the trial (540)Proportion of patients with vaginal or pelvic recurrence over follow-up of 3 to 10 years; no fixed time point in the abstract | finalAalders 1980 | 1.9% | 6.9% | P<.01 |
| Distant metastasisPatients entered on the trial (540)Proportion of patients who developed distant metastases over follow-up of 3 to 10 years; the abstract gives no p-value | finalAalders 1980 | 9.9% | 5.4% | The abstract states that the 5-year survival rate was not improved by external irradiation (no figures given). |
Appears in
Sources
Aalders J, Abeler V, Kolstad P, Onsrud M. Postoperative external irradiation and prognostic parameters in stage I endometrial carcinoma: clinical and histopathologic study of 540 patients. Obstet Gynecol. 1980;56(4):419-27.