Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma

NCT04533620 | Unknown Phase 2 DMC

• 1 other identifier: SPHIC-TR-HNCNS-2020-46
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Recurrent Nasopharyngeal Carcinoma

Keywords

Locally recurrent nasopharyngeal carcinoma; Individualized carbon-ion radiotherapy; Predictive model of mucosal necrosis; Survival; Toxicity

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  From randomization to death or disease progression, a median of 2 years

Secondary Outcomes (8)

• Overall survival

  From randomization to death, a median of 2 years

• Local progression-free survival

  From randomization to local failure, a median of 2 years

• Regional progression-free survival

  From randomization to regional failure, a median of 2 years

• Distant metastasis-free survival

  From randomization to distant metastasis, a median of 2 years

• Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0

  Within 3 months after initiation of radiation therapy

Study Arms (2)

Standardized CIRT

ACTIVE COMPARATOR

Patients will receive standardized CIRT with a dose of 63 GyE/21 fx.

Radiation: Standardized CIRT

Individualized CIRT

EXPERIMENTAL

A previously 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. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively.

Radiation: Individualized CIRT

Interventions

Standardized CIRT RADIATION

CIRT with a dose of 63 GyE/21 fx

Standardized CIRT

Individualized CIRT RADIATION

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. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively.

Individualized CIRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201315, China

Location

Study Officials

• Jiade J Lu, MD

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Kong, MD

CONTACT

+8602138296666-53516; lin.kong@sphic.org.cn

Jiyi Hu, MD, PhD

CONTACT

+8602138296666-53516; jiyi.hu@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jiade J. Lu

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 31, 2020
• Study Start: November 1, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within 5 years after the publication of the study.
• Access Criteria: Data may be shared with radiation oncologists who are interested in examining the efficacy and toxicity of locally recurrent nasopharyngeal carcinoma patients treated with particle beam radiotherapy. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

Locations

CN (1)