Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma: a Randomized Controlled Trial

Predictive-Model Based Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma: a Phase II Randomized Controlled Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037000

Enrollment

Unknown

Registered

2020-08-26

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-28

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

Conditions

Locally Recurrent Nasopharyngeal Carcinoma

Interventions

Control group:Standardized carbon-ion radiotherpay

Experimental group:individualized carbon-ion radiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 17-70 years. 2. Pathologically diagnosed as WHO type 2/3 nasopharyngeal carcinoma. 3. Failed previous definitive radiotherapy at least 6 months ago. 4. Only had 1 previous course of radiotherapy. 5. Eastern Cooperative Oncology Group score: 0-1. 6. Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil > - 2000/mm^3; 2) platelet > 100,000/mm^3; 3) total bilirubin 60ml/min. 7. Willing to accept adequate contraception for women with childbearing potential. 8. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.

Exclusion criteria

Exclusion criteria: 1. Presence of distant metastasis. 2. Without measurable lesion. 3. Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors. 4. Accompanied with severe major organ dysfunction. 5. Presence of mental disease that may influence the understanding of informed consent.

Design outcomes

Primary

Measure	Time frame
progression-free survival;	—

Secondary

Measure	Time frame
Overall survival;Local progression-free survival;Regional progression-free survival;Distant metastasis-free survival;Acute toxicity;Late toxicity;Quality of life;	—

Countries

China

Contacts

Public ContactLin Kong

Shanghai Proton and Heavy Ion Center

lin.kong@sphic.org.cn+86 021-38296666

Outcome results

None listed

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