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Phase I/II trial of carbon ion reirradiation for recurrent thoracic malignant tumors

Phase I/II trial of carbon ion reirradiation for recurrent thoracic malignant tumors

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027003
Enrollment
Unknown
Registered
2019-10-28
Start date
2018-05-01
Completion date
Unknown
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent thoracic malignant tumors

Interventions

Sponsors

Department of Radiation Oncology for Thoracic Tumor, Shanghai Proton and Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Informed consent achieved; Have the ability to comply with the plan; Aged between 18 and 80 years; Cytological or histological diagnosed primary thoracic malignant tumors (non-small cell lung cancer, small cell lung cancer, sarcoma, and malignant thymoma); Received 1 cycle of standard conventional radiotherapy which terminated more than 6months before recurrence; Metastasis was excluded; Patients who can not tolerate or reject concurrent chemotherapy; The KPS score >=60, and the ECOG general status score is 0-1; The anticipated survival will be >= 12 months; Adequate organs' functions; The position of the lesions can meet the requirements of the design of the radiation field; Patients can hold their positions for more than 30 minutes as the treatment requires. The residual movement of normal tissue and tumor at the pathway of beam must be < = 5mm (breath control technique can be used).

Exclusion criteria

Exclusion criteria: Accompanied with other malignant tumors which were not well controlled; The adverse effects of previous treatment have not been recovered; The radiotherapy plan cannot meet the minimum dose coverage and dose volume limit requirements, or can not meet the dose limitation of the normal organs; Have history of thoracic radiation including hypofractionated radiotherapy, brachytherapy or 2 or more cycles of standard conventional radiotherapy before recurrence; Have cardiac pacemakers or other metal prostheses in the radiation area whose function could be affected by high-energy radiation; Doctors think that carbon ion radiotherapy will not benefit the patient; Have diseases that may affect the treatment of carbon ions; Accompanied with serious complications that may affect carbon ion therapy; Unable to understand the purpose of treatment or unwilling/unable to sign informed consent; No capacity for civil conduct or limited capacity for civil conduct. Other situations that physicians do not think it is appropriate to participate in this clinical research.

Design outcomes

Primary

MeasureTime frame
Dose Limited Toxicity;Local control;

Secondary

MeasureTime frame
Progression Free Survival;

Countries

China

Contacts

Public ContactMAO JING-FANG

Shanghai Proton and Heavy Ion Center

jingfang.mao@sphic.org.cn+86 18017312440

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026