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Nasopharyngeal CarcinomaNCT02575547

Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

An observational study of Nasopharyngeal Carcinoma and Malnutrition, run by Zhao Chong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Carcinoma, Malnutrition
What is being tested?
cisplatin and docetaxel
Type of treatment
Injection or infusion
How many people
186 participants
Where
1 siteChina
Study dates
Jun 2015to Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: III-IVb(Union for International Cancer Control,UICC 7th) NPC patients with histologic diagnosis of World Health Organization(WHO) II

Who may be able to join

  • 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
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  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong

Other trials in China

About this study

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

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。

Being tested
cisplatin and docetaxel
Keywords
Nutritional Status, Locoregionally Advanced Nasopharyngeal Carcinoma
Medical subject headings
Nasopharyngeal Carcinoma, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatin and docetaxelDrug

    Also called radiation, enteral nutrition and parenteral nutrition

    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

Study groups in NCT02575547
Study groupRoleWhat they receive
NC+CCRTPatients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)
Receives: Drug: cisplatin and docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body weight

    Measured: baseline and 36 months

Secondary outcomes (9)

  1. Acute Toxicity

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

    Measured: 3 months

  2. Number of Participants With Abnormal Laboratory Values

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

    Measured: 36 months

  3. Adverse Events That Are Related to Treatment

    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.

    Measured: 36 months

  4. Tumor regressive rate after treatment

    Measured: 36 months

  5. Late toxicity

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

    Measured: 36 months

  6. Three-year locoregional relapse free survival rate

    Measured: 36 months

  7. Three-year distance metastasis free survival rate

    Measured: 36 months

  8. Three-year overall survival rate

    Measured: 36 months

  9. Three-year disease free survival rate

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJan 2020
  4. Study completionJun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02575547
Sponsor's protocol ID
2015-FXY-034-Nutrition and NPC
Status last verified
Jul 2020
First submitted
19 Sep 2015
Last updated
30 Jul 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Miao J, Wang L, Ong EHW, Hu C, Lin S, Chen X, Chen Y, Zhong Y, Jin F, Lin Q, Lin S, Hu X, Zhang N, Wang R, Wang C, Guo X, Yit NLF, Shi H, Tan SH, Mai H, Xie C, Chua MLK, Zhao C. Effects of induction chemotherapy on nutrition status in locally advanced nasopharyngeal carcinoma: a multicentre prospective study. J Cachexia Sarcopenia Muscle. 2023 Apr;14(2):815-825. doi: 10.1002/jcsm.13196. Epub 2023 Mar 5.

    PubMed 36872457

Questions about this trial

What is this clinical trial studying?

An observational study of Nasopharyngeal Carcinoma and Malnutrition, run by Zhao Chong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body weight (time frame: baseline and 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02575547, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.

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