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Clinical trial | Emami et al. [20] | van der Zee et al. [21] | Mitsumori et al. [22] | Vasanthan et al. [15] | Issels et al. [23] | Harima et al. [24] |
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Sponsor | RTOG | Dutch Deep Hyperthermia Group | IAAE | IAAE | ESHO, EORTC, NIH | N/A |
Year of publication | 1996 | 2000 | 2007 | 2005 | 2010 | 2001 |
Enrollment period | 1986–1992 6.5 years |
1990–1996 6 years | 1988–2002 3.5 years | 1998–2002 3.5 years | 1997–2006 9.5 years | 1994–1999 |
| | 358 | | | | 40 |
Number of patients | 184 (173) | | 80 | 110 | 341 | |
| | 114 | 143 | 101 | | | | |
Age | | | | | | | | |
HT+ | | 51 | 62 | 73 | | 50 | 51 | 65 |
HT− | | 50 | 64 | 69 | | 45 | 52 | 62 |
Tumor type | Deep-seated tumors of head and neck and pelvis | Loc. adv. cervical cancer | Loc. adv. rectal cancer | Loc. adv. bladder cancer | Locally advanced NSCLC | Locally advanced carcinoma of the uterine cervix | Soft tissue sarcoma | Loc. adv. cervical cancer |
Pretreatment | Heavy: 84% RT, 45% surg, 34% ChT | No | No | No | No | No |
Comparison | TRT versus RT alone | TRT versus RT alone | TRT versus RT alone | TRT versus RT alone | TChT versus ChT in complex treatment | TRT versus RT alone |
Base treatment | EBRT TD ≤ 100 Gy | EBRT + BT TD = 65 Gy | EBRT TD 66–70 Gy | EBRT TD 66–70 Gy | EBRT | EBRT + BT TD = 84 Gy | ChT (EIA) → surgery → RT → ChT (EIA) | EBRT + BT TD = 82.2 Gy |
HT unit(s) | N/A | 3 units: BSD2000, TEM, 4-guide | Thermotron-RF8 | Thermotron-RF8 | BSD2000 | Thermotron-RF8 |
HT protocol | 42.5°C × 30–60′, 1 (before RT) or 2 (bef/aft RT) HTs | 42°C × 60′, 5 HTs after RT 1/week | 42°C × 60′, 5 HTs after RT 1/week | 42°C × 60′, 5 HTs after RT 1/week | 42°C × 60′, 16 HTs interval 3 days | 42°C × 60′, 3 HTs after RT 1/week |
Complete local response (CLR) | | | | | | | | |
HT+ |
CLR 55% | CLR 55% () | | |
CLR + PLR = 34% () |
80% |
CLR 83% | St.insign. | | Statistically insignificant () |
HT− |
CLR 53% | CLR 39% () | | |
CLR + PLR = 16% () |
50% |
CLR 57% | St.insign. | | |
Overall survival (OS) | | | | | | | | |
HT+ | 34% (2 y) | 51% (3 y) | | |
Statistically insignificant () |
73.2% (3 y) () | 79 mnth () | 58% (3 y) |
HT− | 33% (2 y) | 27% (3 y) | | | 74 mnth () | 48% (3 y) |
Local Progression free survival (LPFS) | | | | | | | | |
HT+ | | | | |
Significantly better () |
68.5% (3 yrs) () | 66% (4 y) () | |
HT− | | | | | 55% (4 y) () | |
Progression-free survival (PFS) | | | | | | | | |
HT+ | | | | | | | 32 mn () | |
HT− | | | | | | | 18 mn () | |
Common toxicity | | | | | | | | |
HT+ | 3-4 Grade—22% | | | | | 17% Gr2, 1% Gr3 | 96.4% () | |
HT− | 3-4 Grade—12% | | | | | 4% Grade 2 | 78.5% () | |
|