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

Sponsor
Jiarong Chen, MD (Other)
Overall Status
Unknown status
CT.gov ID
NCT04303975
Collaborator
(none)
300
6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: clinical measurements

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Explorative Study on the Association of High Sensitivity C-Reactive Protein (hsCRP) and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Group 1: Patients with neoadjuvant chemotherapy

The patients of group1 will receive one of the following treatments: neoadjuvant chemotherapy & concurrent chemoradiotherapy neoadjuvant chemotherapy & radiotherapy neoadjuvant chemotherapy & radiotherapy & adjuvant chemotherapy

Other: clinical measurements
Only clinical parameters were recorded, no intervention was made.

Group 2: Patients without neoadjuvant chemotherapy

The patients of group2 will receive one of the following treatments: concurrent chemoradiotherapy concurrent chemoradiotherapy & adjuvant chemoradiotherapy radiotherapy & adjuvant chemotherapy

Other: clinical measurements
Only clinical parameters were recorded, no intervention was made.

Outcome Measures

Primary Outcome Measures

  1. hsCRP levels [Through treatments completion,12 weeks]

    The hscrp levels in the plasma samples from each participant were measured at the following time points: at the time of diagnosis completion/before the initiation of the first neoadjuvant chemotherapy before the initiation of each neoadjuvant chemotherapy before the initiation of the first radiotherapy during radiotherapy, once a week 1 week and 4weeks after the last radiotherapy

  2. Incidence of adverse events [Through treatments completion,12 weeks]

    All adverse events were recorded during treatment(for example, oral mucositis, dermatitis).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiarong Chen, MD

Investigators

  • Principal Investigator: Jiarong Chen, PhD, Affiliated Jiangmen Hospital of Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiarong Chen, MD, Principal Investigator, Jiangmen Central Hospital
ClinicalTrials.gov Identifier:
NCT04303975
Other Study ID Numbers:
  • JM0019002
First Posted:
Mar 11, 2020
Last Update Posted:
Jun 11, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 11, 2020