Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial
Hypothesis:
Addition of external beam radiation after surgery in early stage endometrial cancer improves survival
Site:
Endometrium
Experimental arm:
Surgery followed by 46 Gy in 2 Gy daily fractions, 3 or 4 field technique (Fields: superior border at L5/S1)
Standard Arm:
Surgery alone
Eligibility Criteria
- TAH/BSO without routine LND with these criteria
Invasion Grade >50% (deep) 1 any 2 <50% superficial 3 - WHO score of 0-2
- Histologies allowed:
- Endometrioid (also including adenocarcinoma with squamous features)
- Adenocarcinoma not otherwise specified
- Adenosquamous carcinoma
- Papillary serous carcinoma
- Clear-cell carcinoma
Primary Outcome:
Locoregional recurrence and overall survival
Results:
Outcome | EBRT | Observation | p-value |
---|---|---|---|
Locoregional Recurrences | 4% | 14% | SS |
Overall Survival** | 81% | 84% | NS |
Major Toxicity | 25% | 6% | SS |
- 73% recurrences in the vagina. Rate of distal mets same ~7% each arm
- Prognostic Factors: Age >60, G3, IC predictive for LR; If 2 of 3 criteria, LR 23% vs. 4% (SS)
Conclusions:
Postoperative radiation improves locoregional control, but no survival benefit
See Radiation Oncology WikiBook for more details ↩︎
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