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Trial Title:
Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer
NCT ID:
NCT06103617
Condition:
Head and Neck Cancer
Recurrent Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Recurrence
Penicillamine
Conditions: Keywords:
radiotherapy
radiosensitizer
penicillamine
copper
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Penicillamine
Description:
Participants in this group are treated with Penicillamine (250mg each time, 4 times per
day) during reradiation.
Arm group label:
Penicillamine group
Summary:
Our preclinical study confirmed that copper accumulation can lead to radioresistance in
vitro and in vivo, and reducing the concentration of copper with copper chelator help to
overcome radioresistance. Therefore, the investigators plan to carry out a prospective
interventional phase II clinical trial to explore the safety and efficacy of
penicillamine (a common copper chelator) as a radiosensitizer in the treatment of
recurrent head and neck cancer.
Detailed description:
Head and neck cancer is the sixth most common cancer worldwide. Radiotherapy is an
important measure to control tumor recurrence. Although radiotherapy has been widely used
in patients with head and neck cancer, the 2-year local recurrence rate of patients with
locally advanced disease is still as high as 50%-60%. This is associated with a lower
radiosensitivity in head and neck cancer. High doses of reirradiation (>60 Gy) are
associated with severe late complications and treatment-related mortality. Therefore,
finding an appropriate sensitizer to improve the radiosensitivity is the key to improve
the survival of recurrent patients. Our preclinical study confirmed that copper
accumulation can lead to radioresistance in vitro and in vivo, and the results were
published in J Hepatol (IF=25.7). Penicillamine is a commonly used copper chelator in
clinical practice and can reduce the concentration of copper in the body. Based on this,
the investigators plan to carry out a prospective interventional phase II clinical trial
to explore the safety and efficacy of penicillamine as a radiosensitizer in the treatment
of recurrent head and neck cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign informed consent
2. The age is 18-75 years
3. Previously received standard radical radiotherapy or chemoradiotherapy
4. Head and neck tumors with in situ or cervical lymph node recurrence confirmed by
pathological biopsy and imaging examination
5. ECOG PS：0/1
6. Laboratory examination confirmed good organ function, which should be carried out
within 10 days before the first treatment.
Exclusion Criteria:
1. After evaluation, it does not meet the indications of re-radiotherapy
2. Unable to take oral medication
3. Pregnancy or lactation
4. Known allergy to penicillamine
5. Patients who are judged by the researcher as unsuitable to participate in this
trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern medical university
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Guan, M.D.
Phone:
86+13632102247
Email:
guanjian5461@163.com
Investigator:
Last name:
Jian Guan, M.D.
Email:
Principal Investigator
Facility:
Name:
Nanfang Hospital, Sourthern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Guan, MD
Start date:
November 15, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06103617
