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Completed

NCT Number: NCT04528394

Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201315, China

About this study

The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent [GyE]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).
  • Age ≥ 18 and ≤ 70 years of age.
  • Eastern Cooperative Oncology Group score: 0-1.
  • Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil > 2000/mm^3; 2) platelet > 100,000/mm^3; 3) total bilirubin < 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase < 1.5 upper limit of normal; 5) SCr < 1.5mg/dl; creatinine clearance rate > 60ml/min.
  • Willing to accept adequate contraception for women with childbearing potential.
  • Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.

Exclusion criteria

  • Presence of distant metastasis.
  • Received radiotherapy for head and neck before.
  • Received surgery(except for biopsy) for primary lesion or cervical lymph node.
  • Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
  • Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia.
  • Accompanied with severe major organ dysfunction.
  • Presence of mental disease that may influence the understanding of informed consent.

Treatment and study plan

Photon

Radiation

Photon combined with Carbon ion in Arm 1

Proton

Radiation

Proton combined with Carbon ion in Arm 2

Carbon Ion

Radiation

Same dose and fractionation will be used in both arms.

Primary outcomes

  1. Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03

    Time frame: Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy

    CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment.

Secondary outcomes

  1. Overall survival of all patients

    Time frame: From randomization to death, a median of 3 years.

  2. Progression-free survival of all patients

    Time frame: From randomization to death or disease progression, a median of 3 years.

  3. Local control

    Time frame: From randomization to local failure, a median of 3 years.

  4. Regional control

    Time frame: From randomization to regional failure, a median of 3 years.

  5. Distant control

    Time frame: From randomization to distant failure, a median of 3 year.

  6. Treatment-related adverse events as assessed by NCI CTCAE v4.03

    Time frame: Time interval from start to 3 months after completion of radiotherapy.

    Acute and late toxicities induced by radiation therapy other than xerostomia.

Sponsors and collaborators

Lead sponsor

Shanghai Proton and Heavy Ion Center

Other

Registry information

Official study title

A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
Aug 27, 2020
Registry last updated
Jun 24, 2026

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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