Study on the Safety and Effectiveness of Varian ProBeam Proton Therapy Equipment in the Treatment of Solid Tumors

Last updated: November 2, 2023
Sponsor: Guangzhou Concord Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Cancer Treatment

Neuroblastoma

Neoplasms

Treatment

Proton radiation therapy

Clinical Study ID

NCT05914142
SYSQX-2022-046-02
  • Ages 18-80
  • All Genders

Study Summary

This study is a clinical trial of prospective, single-arm objective performance criteria. This trial will be conducted in clinical trial sites with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.

Eligibility Criteria

Inclusion

Inclusion Criteria:

1.18≤ age≤ 80 years;

2.First-diagnosed patients with tumors of the nervous system, head and neck, chest,abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology;

3.ECOG physical condition is graded as 0 to 2;

4.Women of childbearing had negative results in the blood pregnancy test (Human ChorionicGonadotropin, HCG) 7 days prior to the first treatment;

5.The subject or subject's guardian is able to understand the purpose of the study,demonstrate sufficient compliance with the protocol and sign informed consent form

Exclusion

Exclusion Criteria:

  1. The subject with radiotherapy contraindications, including the known genetictendencies that increase the sensitivity of normal tissue radiotherapy or theaccompanying diseases that lead to hypersensitivity to radiotherapy;
  2. The subject with other uncontrolled tumors except that to be treated according tomedical history or the investigator's estimation, or with other malignant tumorswithin five years prior to enrollment;
  3. Implanted pacemakers or other metal prosthesis within the scope of proton therapy;
  4. Other situations that investigator determines not suitable for enrollment

Study Design

Total Participants: 47
Treatment Group(s): 1
Primary Treatment: Proton radiation therapy
Phase:
Study Start date:
December 15, 2022
Estimated Completion Date:
July 04, 2023

Study Description

Oncology patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors. The screening period from informed consent to enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up will be 3 months after the end of the last treatment. Total expected participation for each subject from screening to the completion of short-term follow-up is a maximum duration of 12 weeks + 3 months. Long-term follow-up continues after the end of short-term follow-up until the 5th year after the end of the last radiotherapy session.

Connect with a study center

  • Varian ProBeam 360

    Guangzhou, Guangdong 510000
    China

    Site Not Available

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