Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT02004795
Eligibility Criteria:
Inclusion Criteria:
* For BNCT:
1. Patients with locoregionally recurrent, histologically proved malignancy of the head and neck, including primary sites of oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinus, nasal cavity, the orbit, thyroid and larynx. Pathology types like melanoma and sarcoma are also included.
2. Prior conventional radiotherapy administered has been given for the disease (except melanoma).
3. Bi-dimensionally measurable disease by MRI and/or CT scan and ≦ 12 cm in largest dimension.
4. Age greater than 18 years and \< 80 years, ECOG performance status ≦ 2
5. WBC \> 2.5 x109/L, neutrophil count \>1.0 x109/L, platelet count \>75x109/L, serum creatinine \<1.25xULN.
6. Informed consent signed.
7. Tumor/normal tissue (T/N) ratio≧2.5 by BPA-PET scan.
* For IG-IMRT:
1. ECOG performance status ≦ 2
2. No evidence of disease progression by physical examination or CT simulation.
3. Nutrition support (feeding tube and/or IV fluid) already given for dysphagia, if present.
4. Severity of mucositis and radiation dermatitis improved or downgrading, compared with those found in the 2nd or 3rd week after BNCT.
Exclusion Criteria:
* For BNCT:
1. Lymphoma or other tumor type that is expected to respond to cancer chemotherapy or to a dose of conventional radiation therapy that can be safely given.
2. Patients who have an effective standard treatment option available.
3. Distant metastasis outside of the head and neck region.
4. Expecting life less than 3 months.
5. A time interval less than 6 months from previous radiation therapy.
6. Prior high-dose radiotherapy (Biological Effective Dose\> 70 Gy/35 fractions) has been given for the present recurrent site within one year.
7. Patients who had radiation myelitis or radiation necrosis of the brain/brain stem
8. Time to recurrence from completion of prior surgery less than 6 months.
9. Concurrent systemic cancer treatment including chemotherapy or target therapy (including cetuximab or EGFR oral tyrosine kinase inhibitor).
10. Severe congestive heart failure or renal failure.
11. Pregnancy
12. Restless patients who were unable to lie or sit in a cast for 30-60 min.
13. A cardiac pace-maker or an unremovable metal implant present in the head and neck region that will interfere with MRI-based dose-planning or tumor response evaluation.
* For IG-IMRT:
1. Any grade IV toxicity after BNCT.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
79 Years
Study:
NCT02004795
Study Brief:
Protocol Section:
NCT02004795