The Association of hsCRP and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma

Jiarong Chen, MD

Status: Unknown

Conditions: Nasopharyngeal Carcinoma; Toxicity Due to Radiotherapy; Head and Neck Cancer

Treatments: Other: clinical measurements

Study type: Observational

Funder types: Other

Identifiers

NCT04303975

JM0019002

Details and patient eligibility

About

The primary purpose of this study is to explore the association of high sensitivity C-reactive protein (hsCRP) and radiotherapy(RT)-induced toxicity in patients with nasopharyngeal carcinoma. In each patient, hsCRP levels in the pre- and post-RT plasma samples will be measured according to the schedule we set.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors
• According to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy
• Willingness to sign the informed consent and return to enrolling institution for follow-up and data collection

Exclusion criteria

• Patients do not conform to the inclusion criteria
• Pregnant or Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Vital organs dysfunction(for example, kidneys, heart, liver, lungs, brain)
• Other contraindications or unsuitable conditions for radiotherapy

Trial design

300 participants in 2 patient groups

Group 1: Patients with neoadjuvant chemotherapy

Description:

The patients of group1 will receive one of the following treatments: 1. neoadjuvant chemotherapy \& concurrent chemoradiotherapy 2. neoadjuvant chemotherapy \& radiotherapy 3. neoadjuvant chemotherapy \& radiotherapy \& adjuvant chemotherapy

Treatment:

Other: clinical measurements

Group 2: Patients without neoadjuvant chemotherapy

Description:

The patients of group2 will receive one of the following treatments: 1. concurrent chemoradiotherapy 2. concurrent chemoradiotherapy \& adjuvant chemoradiotherapy 3. radiotherapy \& adjuvant chemotherapy

Treatment:

Other: clinical measurements