Table 3.
De-intensification trials with reduced RT dose.
| Name study | Design | Inclusion TNM 7th | Inclusion TNM 8th | Smoking | Primary endpoint |
|---|---|---|---|---|---|
| NCT01716195 | One arm: ICT (2 cycli paclitaxel-carboplatin) + response adapted RT (54 Gy or 60 Gy) with weekly paclitaxel | T1T2-N2aN3; T3T4-Nany | T1T2-N1N2 (excluding N1 with only one ipsilateral LN < 3 cm); T3T4-Nany | / | 2Y PFS |
| NCT01530997 | One arm: 60Gy + weekly cisplatin | T0T3-N0N2c | T1T3-N0N2 | < 10PY or < 30PY and abstinent >5Y | Pathologic Complete Remission |
| NRG HN002 NCT02254278 | Reduced 60 Gy + weekly cisplatin vs. 60 Gy | T1T2-N1N2b; T3-N0N2b | T1T2-N1; T3-N0N1 | < 10 PY | 2Y PFS grade 3 dysphagia |
| ECOG 1308 NCT01084083 | ICT (3 cycli of cisplatin, paclitaxel, cetuximab), then response adapted RT (54 or 69.3 Gy) with cetuximab | Resectable disease T3T4-N0; T1N1-T4N3 | Resectable disease T3T4-N0; T1N1-T4N3 | / | 2Y PFS |
| The Quarterback Trial NCT01706939 | ICT (TPF), patients with CR/PR randomized between RT (56Gy) with carboplatin vs. RT (70Gy) with carboplatin | T3T4-N0; T1N1-T4N3 OPC/CUP/nasopharynx | T3T4-N0; T1N1-T4N3 OPC/CUP/nasopharynx | Exclusion of active smokers or >20 PY | 3Y PFS |
ICT, induction chemotherapy; TPF, docetaxel, cisplatin, 5-fluorouracil; CR/PR, complete response / partial response; RT, radiotherapy; OPC, Oropharyngeal carcinoma; CUP, carcinoma of unknown primary; PY, smoking pack years; 2Y, up to 2 years after end of treatment; PFS, progression free survival.