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NCT Number: NCT02575547

Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

This is an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Malnutrition Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nutrition Disorders Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II)
  • All genders，range from 18～65 years old
  • Karnofsky performance status(KPS) ≥ 80
  • Clinical stage III~IVb(UICC 7th)
  • 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

Exclusion criteria

  • 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

Treatment and study plan

cisplatin and docetaxel

Drug

NC：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two courses.

CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\\three cycles during radiation therapy(RT).

Dietary supplement: enteral nutrition and parenteral nutrition

Other names: radiation, enteral nutrition and parenteral nutrition

Primary outcomes

  1. Change in Body weight

    Time frame: baseline and 36 months

Secondary outcomes

  1. Acute Toxicity

    Time frame: 3 months

    To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 3.0 when adjuvant chemotherapy and concurrent chemoradiation is used.

  2. Number of Participants With Abnormal Laboratory Values

    Time frame: 36 months

    To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.

  3. Adverse Events That Are Related to Treatment

    Time frame: 36 months

    Using European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 4/5 cycles of chemotherapy, 3 years after all treatment finished.

  4. Tumor regressive rate after treatment

    Time frame: 36 months

  5. Late toxicity

    Time frame: 36 months

    To evaluate the late toxicity with the SOMA criterion after 1/2/3 years of treatment.

  6. Three-year locoregional relapse free survival rate

    Time frame: 36 months

  7. Three-year distance metastasis free survival rate

    Time frame: 36 months

  8. Three-year overall survival rate

    Time frame: 36 months

  9. Three-year disease free survival rate

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Zhao Chong

Other

Collaborators

  • Cancer Hospital of Guizhou Province
  • First Affiliated Hospital of Guangxi Medical University
  • First People's Hospital of Foshan
  • Fudan University
  • Fujian Cancer Hospital
  • Hainan People's Hospital
  • The First Affiliated Hospital of Xiamen University
  • Wuhan University
  • Zhejiang Cancer Hospital

Registry information

Official study title

Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemo-radiotherapy on Nutritional Status in Locoregionally Advanced Nasopharyngeal Carcinoma Patients: Prospective Observational Study

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2015
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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