Image

18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma

Recruiting
18 - 80 years of age
Both
Phase 2

Powered by AI

Overview

The purpose of this study is to explore whether 18F-FDG PET/CT guided reduced-dose radiotherapy would maintain survival outcomes in nasopharyngeal carcinoma (NPC) patients.

Description

Enrolled patients with complete metabolic response (CMR) and more than 70% partial metabolic response (PMR) according to PERCIST criteria at the 25th fraction will receive intensity modulated radiation therapy (IMRT) of reduced-dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions), for those who with ≤70% PMR will receive conventional dose (prescribed dose, 70Gy, 2.12 Gy per fractions, 33 fractions).

Eligibility

Inclusion Criteria:

  1. Pathology confirmed nasopharyngeal squamous cell carcinoma.
  2. Stage I-IVA(8thAJCC/UICC staging system).
  3. Aged 18-80 years.
  4. KPS≥70.
  5. Have measurable lesions on 18F-FDG PET/CT before treatment.
  6. HGB≥90 g/L,ANC≥1.5×109 /L,PLT≥80×109 /L.
  7. ALT,AST<2.5 fold of ULN;TBIL<2.0×ULN.
  8. CCR≥60ml/min or Cr<1.5×ULN.
  9. Signed informed consent.
  10. Have follow up condition.

Exclusion Criteria:

  1. Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ).
  2. Age <18 or >80years.
  3. Pregnancy or lactation.
  4. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  6. With sever infection and internal disease.
  7. Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.

Study details

Nasopharyngeal Carcinoma

NCT04813705

Taizhou Hospital

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.