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FFCD 9203

Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203

Phase 3N = 733

Population
Patients with resectable T3-4, Nx, M0 rectal adenocarcinoma accessible to digital rectal examination (eligible patients)
Design
Randomised trial in patients with a resectable T3-4, Nx, M0 rectal adenocarcinoma accessible to digital rectal examination; 733 patients were eligible. Preoperative radiotherapy was 45 Gy in 25 fractions over 5 weeks; the experimental arm added concurrent fluorouracil (350 mg/m2 per day for 5 days) with leucovorin in the first and fifth weeks. Surgery was planned 3 to 10 weeks after radiotherapy. All patients were to receive adjuvant chemotherapy with the same fluorouracil and leucovorin regimen.
Primary endpoint
OS
Arms
  • Preoperative radiotherapy (control): 45 Gy in 25 fractions over 5 weeks, then surgery 3 to 10 weeks later; adjuvant fluorouracil and leucovorin planned for all patients
  • Preoperative chemoradiotherapy (experimental): 45 Gy in 25 fractions with concurrent fluorouracil (350 mg/m2 per day for 5 days) and leucovorin in weeks 1 and 5, then surgery 3 to 10 weeks later; adjuvant fluorouracil and leucovorin planned for all patients
People
Gérard JP
Δ 60-month Local recurrence−8.4 pointsΔ Grade 3-4 acute toxicity+11.9 pointsΔ pCR+7.8 points
Show the numbers
Results reported for FFCD 9203
EndpointAnalysisPreoperative chemoradiotherapyPreoperative radiotherapyEffect
Local recurrenceEligible patients (733)5-year incidence of local recurrenceprimaryGérard 20068.1% at 5 y16.5% at 5 yP<0.05The abstract states that overall 5-year survival did not differ between the groups (values not given) and that there was no difference in sphincter preservation.
Grade 3-4 acute toxicityEligible patients (733)primaryGérard 200614.6%2.7%P<0.05
pCREligible patients (733)Complete sterilization of the operative specimenprimaryGérard 200611.4%3.6%P<0.05
Results reported for FFCD 9203
EndpointAnalysisPreoperative chemoradiotherapyPreoperative radiotherapyEffect
Local recurrenceEligible patients (733)5-year incidence of local recurrenceprimaryGérard 20068.1% at 5 y16.5% at 5 yP<0.05The abstract states that overall 5-year survival did not differ between the groups (values not given) and that there was no difference in sphincter preservation.
Grade 3-4 acute toxicityEligible patients (733)primaryGérard 200614.6%2.7%P<0.05
pCREligible patients (733)Complete sterilization of the operative specimenprimaryGérard 200611.4%3.6%P<0.05
Primary publication: Gérard JP, Conroy T, Bonnetain F, Bouché O, Chapet O, Closon-Dejardin MT, et al. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol. 2006;24(28):4620-5. PubMedDOI

Appears in

Sources

  1. Gérard JP, Conroy T, Bonnetain F, Bouché O, Chapet O, Closon-Dejardin MT, et al. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol. 2006;24(28):4620-5.

    PubMedDOI