Table 1.
Baseline demographic and clinical characteristics in the modified ITT population
| Usual care group (n=102) | External beam radiotherapy group (n=97) | |
|---|---|---|
| Randomisation time point | ||
| Before stent insertion | 39 (38%) | 36 (37%) |
| After stent insertion | 63 (62%) | 61 (63%) |
| Age, years | 73·5 (65·4–81·5); 102 | 72·0 (65·3–79·9); 97 |
| WHO performance status | ||
| 0 | 10 (10%) | 10 (10%) |
| 1 | 61 (60%) | 59 (61%) |
| 2 | 27 (26%) | 27 (28%) |
| 3 | 4 (4%) | 1 (1%) |
| Tumour type | ||
| Adenocarcinoma | 68 (67%) | 61 (63%) |
| Squamous | 33 (32%) | 34 (35%) |
| Undifferentiated or other | 1 (1%) | 2 (2%) |
| Overall length of primary tumour (endoscopic assessment)* | ||
| Measured length, cm | 5·0 (4·0–7·0); 64 | 6·0 (4·0–8·0); 57 |
| Estimated length, cm | 6·0 (4·5–8·0); 28 | 7·0 (5·0–8·0); 33 |
| Measured or estimated length, cm | 5·9 (4·0–7·0); 92 | 6·0 (4·5–8·0); 90 |
| Missing | 10 (10%) | 7 (7%) |
| Alternative method for assessing length* | ||
| PET | 5 (5%) | 7 (7%) |
| CT | 23 (23%) | 23 (24%) |
| Missing | 0 | 3 (3%) |
| Site of predominant tumour | ||
| Upper oesophagus | 3 (3%) | 3 (3%) |
| Middle oesophagus | 24 (24%) | 25 (26%) |
| Lower oesophagus | 75 (74%) | 68 (70%) |
| If lower oesophagus: involvement of GOJ | 38 (37%) | 38 (39%) |
| Unknown | 0 | 1 (1%) |
| Extension across GOJ (if involvement of GOJ) | ||
| Siewert type 1 | 21 (21%) | 20 (21%) |
| Siewert type 2 | 15 (15%) | 13 (13%) |
| Missing | 2 (2%) | 5 (5%) |
| T stage† | ||
| 0 | 1 (1%) | 0 |
| 1 | 1 (1%) | 1 (1%) |
| 2 | 4 (4%) | 7 (7%) |
| 3 | 61 (60%) | 54 (56%) |
| 4 | 29 (28%) | 31 (32%) |
| Missing | 6 (6%) | 4 (4%) |
| N stage† | ||
| 0 | 17 (17%) | 10 (10%) |
| 1 | 46 (45%) | 46 (47%) |
| 2 | 20 (20%) | 20 (21%) |
| 3 | 15 (15%) | 17 (18%) |
| Missing | 4 (4%) | 4 (4%) |
| M stage† | ||
| 0 | 46 (45%) | 41 (42%) |
| 1 | 49 (48%) | 50 (52%) |
| Missing | 7 (7%) | 6 (6%) |
| Overall stage† | ||
| I–III | 51 (50%) | 46 (47%) |
| IV | 51 (50%) | 51 (53%) |
| Previous chemotherapy given‡ | ||
| No | 87 (85%) | 74 (76%) |
| Yes | 15 (15%) | 23 (24%) |
| Chemotherapy intended after stent insertion | ||
| Yes | 36 (35%) | 34 (35%) |
| No | 66 (65%) | 63 (65%) |
| EQ-5D-3L index scores | 0·648 (0·226); 102 | 0·578 (0·297); 97 |
Data are n (%), median (IQR); n, or mean (SD); n. ITT=intention to treat. GOJ=gastric-oesophageal junction. EQ5D=EuroQol-5D-3L.
*
In addition to endoscopic assessment in some patients.
†
At diagnosis.
‡
Details of therapies provided in the appendix p 20.