Locally Recurrent Nasopharyngeal Carcinoma Clinical Trial
Official title:
Predictive-Model Based Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma: A Phase 2 Randomized Trial
This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized carbon-ion radiotherapy (CIRT). For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups.
| Status | Not yet recruiting |
| Enrollment | 96 |
| Est. completion date | September 30, 2025 |
| Est. primary completion date | September 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Aged between 17-70 years. - Pathologically diagnosed as WHO type 2/3 nasopharyngeal carcinoma. - Failed previous definitive radiotherapy at least 6 months ago. - Only had 1 previous course of radiotherapy. - Eastern Cooperative Oncology Group score: 0-1. - 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 < 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase < 1.5 upper limit of normal; 5) SCr < 1.5mg/dl; creatinine clearance rate > 60ml/min. - Willing to accept adequate contraception for women with childbearing potential. - Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial. Exclusion Criteria: - Presence of distant metastasis. - Without measurable lesion. - Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors. - Accompanied with severe major organ dysfunction. - Presence of mental disease that may influence the understanding of informed consent. |
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai Proton and Heavy Ion Center | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Proton and Heavy Ion Center |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival | From randomization to death or disease progression, a median of 2 years | ||
| Secondary | Overall survival | From randomization to death, a median of 2 years | ||
| Secondary | Local progression-free survival | From randomization to local failure, a median of 2 years | ||
| Secondary | Regional progression-free survival | From randomization to regional failure, a median of 2 years | ||
| Secondary | Distant metastasis-free survival | From randomization to distant metastasis, a median of 2 years | ||
| Secondary | Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0 | Within 3 months after initiation of radiation therapy | ||
| Secondary | Incidence of radiation-induced late toxicity evaluated by CTCAE 5.0 | Three months after initiation of radiation therapy | ||
| Secondary | Quality of life by questionnaires evaluated using EORTC-Q30 questionnaire. | Throughout the study, an average of 2 years | ||
| Secondary | Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire. | Throughout the study, an average of 2 years |