Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06472739

The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy

Led by Sun Yat-sen University · Updated on 2024-06-25

138

Participants Needed

1

Research Sites

61 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.

CONDITIONS

Official Title

The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO II or III)
  • Clinical stage II to IVa according to the 8th AJCC edition
  • Male or female who are not pregnant
  • No evidence of distant metastasis (M0)
  • Age between 18 and 65 years
  • White blood cell count >= 4 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 90 g/L
  • Normal liver function tests: ALT, AST < 1.5x upper limit of normal; ALP <= 2.5x upper limit of normal; bilirubin <= upper limit of normal
  • Normal renal function: creatinine clearance >= 60 ml/min or creatinine < 1.5x upper limit of normal
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 1
  • Informed consent provided
  • Receiving induction chemotherapy plus concurrent chemoradiotherapy, or concurrent chemoradiotherapy, or radiotherapy alone
Not Eligible

You will not qualify if you...

  • Age under 18 or over 65 years
  • Clinical stage I or IVb according to the 8th AJCC edition
  • Tumor recurrence or distant metastasis
  • Prior malignancy except treated basal or squamous cell skin cancer, or in situ cervical cancer
  • History of previous radiotherapy except for skin cancers outside treatment volume
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
  • Pregnancy or lactation
  • Any severe intercurrent disease posing unacceptable risk or affecting trial compliance, such as unstable cardiac disease, acute exacerbation of chronic respiratory illness requiring hospital admission, renal disease, chronic hepatitis, poorly controlled diabetes, or mental disturbance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

Q

Qiu Yan Chen, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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