Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Valerio Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female
Aged \> 18 years
Suffering from a newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx histologically-confirmed and having undergone resective surgery
Prior neoadjuvant chemotherapy allowed provided that, the patient did not experience a World Health Organization (WHO) grade \> 2 oral mucositis during the neoadjuvant therapy.
Patient eligible to receive concurrent chemo-radiation defined as:
1. A continuous course of conventional external beam irradiation (IMRT eligible) with a minimum cumulative radiation dose of 50 Gy or a maximum of 70 Gy, based on a daily dosing between 1.8 and 2.2 Gy combined with platinum based chemotherapy on a weekly or tri-weekly cycles.
2. Planned radiation treatment fields must include at least two oral tissue sites (among right or left buccal mucosa, floor of mouth, tongue, right or left soft palate) with each site receiving a total of 50 Gy or a maximum of 70 Gy. The radiation treatment plan will be reviewed by a designated radiation oncologist.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Screening laboratory tests:
1. Haemoglobin ≥ 10g/dL
2. Absolute neutrophil counts ≥ 1500 cells/mm3
3. Platelets ≥ 100.000/mm3
4. Conjugated bilirubin ≤ 2 times Upper Limit of Normal (ULN)
