NCT03240835

Brief Summary

The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 12, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

July 27, 2017

Last Update Submit

January 29, 2023

Conditions

Nasopharyngeal CarcinomaMalnutrition

Keywords

pre-AlbuminRetinol Conjugated ProteinTransferrinLocoregionally Advanced Nasopharyngeal Carcinomanutrition

Outcome Measures

Primary Outcomes (1)

  • changes of PA/RBP/TRSF

    to evaluate the changes of PA/RBP/TRSF during the treatment

    baseline and during treatment

Secondary Outcomes (3)

  • Change of Body weight

    baseline and during treatment

  • Number of Participants With Abnormal Laboratory Values

    baseline and during treatment

  • Acute Toxicity

    baseline and during treatment

Study Arms (1)

CCRT±NACT

Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only

Drug: cisplatin and docetaxelRadiation: IMRT

Interventions

cisplatin and docetaxelDRUG

NACt：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two cycles. CCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles.

CCRT±NACT
IMRTRADIATION

intensity modulation radiation therapy

CCRT±NACT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

III-IVb(Union for International Cancer Control,UICC 8th) NPC patients with histologic diagnosis of World Health Organization(WHO) II/III

You may qualify if:

  • Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
  • All genders，range from 18～60 years old
  • Karnofsky performance status(KPS) ≥ 80
  • Clinical stage III\~IVb(UICC 8th)
  • Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
  • Without significant cardiac，respiratory，kidney or liver disease
  • Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
  • white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
  • alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 1.5×upper limit of normal(ULN), bilirubin \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
  • Inform consent form

You may not qualify if:

  • Distance metastases
  • Second malignancy within 5 years
  • Drug or alcohol addition
  • Do not have full capacity for civil acts
  • Active systemic infections
  • Chronic consumptions
  • Mental disorder
  • Pregnancy or lactation
  • Concurrent immunotherapy or hormone therapy for other diseases
  • Severe complication, eg, uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal CarcinomaMalnutrition

Interventions

CisplatinDocetaxel

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 7, 2017

Study Start

September 12, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

CN(1)