Palliative radiotherapy after oesophageal cancer stenting (ROCS): a multicentre, open-label, phase 3 randomised controlled trial

Abstract

Summary Background Patients with advanced oesophageal cancer have a median survival of 3–6 months, and most require intervention for dysphagia. Self-expanding metal stent (SEMS) insertion is the most typical form of palliation in these patients, but dysphagia deterioration and re-intervention are common. This study examined the efficacy of adjuvant external beam radiotherapy (EBRT) compared with usual care alone in preventing dysphagia deterioration and reducing service use after SEMS insertion. Methods This was a multicentre, open-label, phase 3 randomised controlled trial based at cancer centres and acute care hospitals in England, Scotland, and Wales. Patients (aged ≥16 years) with incurable oesophageal carcinoma receiving stent insertion for primary management of dysphagia were randomly assigned (1:1) to receive usual care alone or EBRT (20 Gy in five fractions or 30 Gy in ten fractions) plus usual care after stent insertion. Usual care was implemented according to need as identified by the local multidisciplinary team (MDT). Randomisation was via the method of minimisation stratified by treating centre, stage at diagnosis (I–III vs IV), histology (squamous or non-squamous), and MDT intent to give chemotherapy (yes vs no). The primary outcome was difference in proportions of participants with dysphagia deterioration (>11 point decrease on patient-reported European Organisation for Research and Treatment of Cancer quality of life questionnaire-oesophagogastric module [QLQ-OG25], or a dysphagia-related event consistent with such a deterioration) or death by 12 weeks in a modified intention-to-treat (ITT) population, which excluded patients who did not have a stent inserted and those without a baseline QLQ-OG25 assessment. Secondary outcomes included survival, quality of life (QoL), morbidities (including time to first bleeding event or hospital admission for bleeding event and first dysphagia-related stent complications or re-intervention), and cost-effectiveness. Safety analysis was undertaken in the modified ITT population. The study is registered with the International Standard Randomised Controlled Trial registry, ISRCTN12376468, and ClinicalTrials.gov , NCT01915693 , and is completed. Findings 220 patients were randomly assigned between Dec 16, 2013, and Aug 24, 2018, from 23 UK centres. The modified ITT population (n=199) comprised 102 patients in the usual care group and 97 patients in the EBRT group. Radiotherapy did not reduce dysphagia deterioration, which was reported in 36 (49%) of 74 patients receiving usual care versus 34 (45%) of 75 receiving EBRT (adjusted odds ratio 0·82 [95% CI 0·40–1·68], p=0·59) in those with complete data for the primary endpoint. No significant difference was observed in overall survival: median overall survival was 19·7 weeks (95% CI 14·4–27·7) with usual care and 18·9 weeks (14·...

Phase I trial of hypofractionated chemoradiotherapy in the palliative management of esophageal and gastro-esophageal cancer

“…The ROCS trial randomized 199 patients receiving an esophageal stent to the addition of radiotherapy, nding no dysphagia free advantage for the combined group (22). Overall survival in ROCS was less than 5 months, suggesting that favorable patient selection for multimodal treatment is important.…”

Stent insertion for incurable oesophageal carcinoma: what is the optimal treatment? – Authors' reply

“…1 0 1 6/ S 2 4 6 8-1 2 5 3( 2 We thank Dong Tian and colleagues for their interest in the ROCS trial. 1 The primary outcome of patient-reported differences in dysphagia recurrence is in keeping with the demand for studies which address quality of life in this palliative group, rther than survival. 2,3 The trial was stratified for those preplanned to receive chemotherapy, but was not powered to detect a difference in overall survival on the basis of chemotherapy receipt.…”

Health-related quality of life one year after the diagnosis of oesophageal cancer: a population-based study from the Swedish National Registry for Oesophageal and Gastric Cancer

“…As mentioned above, data on patient reported HRQOL in patients managed palliatively is scarce, and there is no documented knowledge regarding HRQOL in palliative subgroups, for example by the reason for the palliative management intention or type of therapy. Published studies on palliative patients have mainly focused on dysphagia symptom management [ 7 , 13 – 15 ] and there is a clear knowledge gap regarding the overall HRQOL in unselected patients with oeophageal cancer [ 6 , 16 ].…”