Table 5 A selection of prospective trials in localised oesophageal cancer in the participating countries
Group/Name of the trial | Background Objectives | Endpoints Design | Sample size | (planned) date of trial initiation |
|---|---|---|---|---|
SAKK 75/08 (Swiss, German, Austrian and French centers) NCT01107639 | Multimodal therapy with and without cetuximab, locally advanced esophageal carcinoma. | Ph-lll: PFS | 300 | Accrual fulfilled, results expected Q15 |
FFCD/FRENCH (ESOSTRATE trial) | Operable oesophageal cancer with clinical complete response after neoadjuvant chemoradiation randomised between systematic surgery vs surveillance with selective salvage surgery in case of operable recurrence | Ph-ll: Percentage of patients alive at 1 year >70 % in the surveillance arm Ph-lll: DFS | Pts randomised with cCR: Ph-ll: 114 Ph-lll: 260 | 1Q 2015 |
Open Versus Laparoscopically-assisted Esophagectomy for Cancer (MIRO) FREGAT NCT00937456 | Hybrid MIO vs open oesophagectomy | Ph. III: overall morbidity, DFS, OS, QoL, economical interest of the surgical technique through a hospital point of view | 200 | Closed to recruitement |
MAGIC vs. CROSS Upper GI. ICORG 10–14, V3 (NEOAEGIS) NCT01726452 | Phase III trial comparing neoadjuvant chemotherapy to chemoradiation in junctional adenocarcinomas (NEOAEGIS) | Ph. III: OS, clinical and pathological response rate, health-related QoL, tumour regression grade, node-positivity, post-operative pathology, DFS, time to treatment failure, toxicity, post-operative complications. | 366 | ongoing |
PROTECT-01 trial FFCD-UNICANCER-FREGAT (NCT02359968) | Phase II/III randomised comparison of preoperative chemoradiation with paclitaxel-carboplatine or with fluorouracil-oxaliplatine-folinic acid (FOLFOX) for unresectable esophageal and junctional cancer | Ph II: complete surgical resection (R0) and severe postoperative morbidity Ph III: overall survival | Ph II: 96 Ph III 400 | Q1 2015 |
FREGAT database fregat-database.org | French prospective national database collecting epidemiological, clinical, pathological, biological, HRQOL and social data on esophageal and gastric cancer | not applicable | 15 000 | On going |
Art-Deco trial (NTR3532) | Dose escalation in irresectable T4- tumours: 50.4 Gy versus 61. Gy plus carboplatin/paclitaxel | Ph. III: local tumour control in the esophagus | 2x 130 patients | Since 2012 |
Pre-SANO trial (NTR4834) | Accuracy of assessment of tumour response after CROSS | Prospective, non-randomised: correlation between cCR and pCR 12 weeks after end of CROSS | 140 | Since 2013 |
Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy (ROBOT) NCT01544790 | Evaluate the benefits, risks and costs of robot-assisted thoraco-laparoscopic esophagectomy as an alternative to open transthoracic esophagectomy as treatment for esophageal cancer. | Ph-lll | 112 | Since 2012 |
Feasibility Study of Chemoradiation, TRAstuzumab and Pertuzumab in Resectable HER2+ Esophageal Carcinoma (TRAP) NCT02120911 | CROSS + Trastuzumab + Pertuzumab in HER positive tumours | Ph I/II: Safety and efficacy; % of patients completing trastuzumab and pertuzumab treatment | 40 | Since 2014 |
TOR trial NTR3060 RACE | High dose CRT followed by exploratory thoracotomy for cT4 tumours | The ability to achieve a radical (R0) resection. | 30 | 2012 |
Prospective randomised comparison of neoadjuvant radiochemotherapy versus chemotherapy in patients with resectable adenocarcinomas of the oesophago-gastric junction | Multicentre phase II/III trial with a 15 % improvement of 3-year DFS by neoadjuvant radio-chemotherapy compared to chemotherapy as primary endpoint | 300 patients | 2015 |