| NSCLC trial | Breast cancer trial | HNSCC trial | All three trials |
---|---|---|---|---|
Acute toxicity phase | Non-hematological toxicity: • Radiation pneumonitis gr ≥ 3 • Any other non-hematological gr ≥ 3 toxicity (other than radiation esophagitis/dysphagia, radiation dermatitis, fatigue, nausea and vomiting, weight loss, anorexia and dehydration) • Gr ≥ 4 radiation esophagitis/dysphagia, radiation dermatitis, fatigue, nausea and vomiting, weight loss, anorexia and dehydration in the presence of maximal support/treatment. • Gr 3 radiation dermatitis present ≥ 9 weeks after end of treatment • Gr 2 cardiac or neurological toxicity Treatment discontinuation#: • Any radiotherapy discontinuation • Cisplatin cumulative discontinuation for > 20% of the total prescribed dose | Non-hematological toxicity: • Radiation dermatitis gr 4 except if this is associated with and at the localization of the ulcerative tumour • Radiation dermatitis gr 3 present ≥ 7 weeks after end of treatment • Pain related to dermatitis gr ≥ 3 present ≥ 7 weeks after end of treatment • Edema breast gr 3 in the presence of maximal support/treatment • Nausea and vomiting gr ≥ 3 in the presence of maximal support/treatment • Esophagitis gr ≥ 3 • Any other non-hematological toxicity gr ≥ 3 (except radiation dermatitis, pain, edema, nausea, vomiting, anorexia, weight loss and fatigue) Treatment discontinuation: • Any radiotherapy discontinuation due to toxicity attributable to radiotherapy, irrespective of the grade of toxicity • Cumulative discontinuation of radiotherapy for > 5 fractions due to toxicity attributable to olaparib, irrespective of the grade of toxicity | Non-hematological toxicity: • Gr ≥ 4 mucositis, dysphagia, radiation dermatitis, anorexia • Gr ≥ 3 hemorrhage, aspiration, trismus • Gr ≥ 3 radiation dermatitis present ≥ 8 weeks after end of treatment • Gr ≥ 3 nausea and/or vomiting in the presence of maximal support • Only in patients with oropharynx SCC: gr ≥ 3 larynx edema • Weight loss ≥ 20% of baseline weight Treatment discontinuation#: • Cumulative discontinuation of radiotherapy for > 3 fractions | Hematological toxicity: • Neutropenia gr 4 lasting for > 6 days • Neutropenic fever gr ≥ 3 • Thrombocytopenia gr 3 in the presence of bleeding; Thrombocytopenia gr ≥ 4 • Anemia gr 3 in the presence of blood transfusion dependency as judged by the PI; Anemia gr ≥ 4 Other: • Any other toxicity, which in the judgment of the Investigator is viewed as DLT Treatment discontinuation#: • Olaparib total discontinuation for > 20% of the total prescribed dose |
Late toxicity phase | Non-hematological toxicity: • Gr ≥ 3 radiation pneumonitis, brachial plexopathy, esophageal stenosis, esophageal ulcer, esophageal necrosis, esophageal hemorrhage • Gr ≥ 2 myelitis, esophageal perforation, esophageal fistula | Non-hematological toxicity: • Fibrosis gr ≥ 3 outside the boost field AND if applicable outside the skin bolus field • Skin ulceration gr ≥ 2 except if this is persisting acute toxicity associated with and at the localisation of the ulcerative tumour • Radiation pneumonitis gr ≥ 3 • Esophagitis gr ≥ 3 • Brachial plexopathy gr ≥ 2 except if there was pre-existing brachial plexopathy or if the brachial plexopathy is tumour progression related | Non-hematological toxicity: • Gr ≥ 4 dysphagia, aspiration • Gr ≥ 3 hemorrhage, skin atrophy, trismus, osteoradionecrosis, radiation dermatitis, pneumonitis • Gr ≥ 2 fistula, myelitis • Gr ≥ 2 mucosal ulcer present ≥ 6 months after end of treatment • Fibrosis limiting joint or orifice movement (e.g. mouth) and/or limiting self-care ADL • Only in patients with oropharynx SCC: gr ≥ 3 larynx stenosis | Hematological toxicity: • Blood transfusion dependency as judged by the PI, unless the patient has progressive disease • Development of MDS/AML Other: • Any other toxicity, which in the judgment of the Investigator is viewed as DLT |