| General information |
| Database: | DB00412 |
| Objective: | Definitive chemoradiotherapy (CRT) is an alternative to surgery for the curative treatment of oesophageal carcinoma. The SCOPE1 trial aimed to investigate the addition of cetuximab to cisplatin and fluoropyrimidinebased definitive CRT in patients with localised oesophageal squamouscell cancer and adenocarcinomas to assess activity, safety, and feasibility of use. |
| Authors: | Crosby T, et al |
| Title: | Chemoradiotherapy with or without cetuximab in patients with oesophageal cancer (SCOPE1): a multicentre, phase 2/3 randomised trial. |
| Journal: | Lancet Oncol. |
| Year: | 2013 |
| PMID: | 23623280 |
| Trial Design |
| Clinical Trial Id: | NCT47718479 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | carcinoma of the oesophagus |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | Chemoradiotherapy with or without cetuximab |
| Study Type: | multicentre, randomised, openlabel, parallel, twoarm, phase II/III trial, |
| Key Patients Feature: | nonmetastatic, histologicallyconfirmed carcinoma of the oesophagus (adenocarcinoma, squamouscell, or undifferentiated carcinoma)or gastrooesophageal junction (Sietheyrt type 1 or 2 with<2 cm extension into the stomach); selected for definitivechemoradiotherapy by a designated multidisciplinaryteam; aged 18 years or older; WHO performance status0 or 1; stage I-III disease (TNM stage 6); and diseaselength of less than 10 cm defi ned by endoscopicultrasound. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:CRT alone B:CRT with cetuximab |
| Treatment Info: | patients were randomly assigned (1:1) via a central computerised system using stratified minimisation (with an 80:20 random element) to receive CRT alone or CRT with cetuximab (400 mg/m(2) on day 1 followed by 250 mg/m(2) weekly), stratified by recruiting hospital, primary reason for not having surgery, tumour histology, and tumour stage. CRT consisted of cisplatin 60 mg/m(2) (day 1) and capecitabine 625 mg/m(2) twice daily (days 121) for four cycles; cycles three and four were given concurrently with 50 Gy in 25 fractions of radiotherapy. |
| Primary End Point: | the proportion of patients who were treatment failure free at week 24 for the phase 2 trial and overall survival for the phase 3 trial |
| Secondary End Point: | NA |
| Patients Number: | 258 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 15.9 months [95% CI 11.0-21.1] vs 21.6 months [16.2-27.8] |
| Median OS A vs. C: | 22.1 months (95% CI 15.1-24.5) in the CRT plus cetuximab group and 25.4 months (20.5-37.9) in the CRT only group. |
| Adverse Event(agent arm): | Patients who received CRT plus cetuximab had more nonhaematological grade 3 or 4 toxicities (102 [79%] of 129 patients vs 81 [63%] of 129 patients; p=0.004). The most common grade 3 or 4 toxicities were low white blood cell count (14 [11%] in the CRT plus cetuximab group vs 21 [16%] in the CRT only group), low absolute neutrophil count (15 [12%] vs 24 [19%]), fatigue (26 [20%] vs 25 [19%]), and dysphagia (35 [27%] vs 37 [29%]). |
| Conclusions: | The addition of cetuximab to standard chemotherapy and radiotherapy cannot be recommended for patients with oesophageal cancer suitable for definitive CRT. |