Introduction Resection remains the best treatment for local control of oesophageal carcinoma (OC), but local recurrence, distant metastasis and poor survival remain an issue after surgery. Often investigated in locally advanced OC, the impact of neoadjuvant chemoradiotherapy (NCRT) is unknown in patients with stage I or II OC. The aim of this multicentre randomised controlled phase III trial was to assess whether NCRT improves outcomes for patients with stage I or II OC.
Methods 195 patients were randomly assigned to surgery alone (S group, n=98) or to NCRT group (NCRT group, n=97; 45Gy given in 25 fractions over 5 weeks with two courses of concomitant chemotherapy by 5-Fluorouracil 800 mg/m2 on days 1–4 and cisplatin 75 mg/m2 on day 1 or 2). The primary endpoint was overall survival. Secondary endpoints were progression free survival, postoperative morbidity and 30-day mortality, R0 resection rate and prognostic factor identification. Analysis was done by intention to treat.
Results Patient and tumour characteristics were well-balanced between the two groups. Patients were preoperatively staged I in 18%, IIA in 49.7%, IIB in 31.8%, unknown in 0.5%. Postoperative morbidity and 30-day mortality rates were 49.5% vs 43.9% (p=0.17) and 1.1% vs 7.3% (p=0.054) in the S group and NCRT group, respectively. After a median follow-up of 5.7 years, 106 deaths were observed. Median survivals were 43.8 vs 31.8 months, respectively (HR 0.92, 95% CI 0.63 to 1.34, p=0.66). The trial was stopped due to futility.
Conclusion Compared with surgery alone, NCRT with cisplatin and 5-Fluorouracil does not improve overall survival but enhances postoperative mortality for patients with stage I or II OC (Clinical Trial.gov identifier NCT 00047112).
Funding Funded by the French ministry of Health—Programme Hospitalier de Recherche Clinique 1999.
Competing interests None declared.