A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Shanghai Proton and Heavy Ion Center
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jiade J. Lu
Executive Vice-President
Shanghai Proton and Heavy Ion Center
Eligibility Criteria
Inclusion Criteria
- •Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).
- •Age ≥ 18 and ≤ 70 years of age.
- •Eastern Cooperative Oncology Group score: 0-
- •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.
Outcomes
Primary Outcomes
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
- Local control(From randomization to local failure, a median of 3 years.)
- Overall survival of all patients(From randomization to death, a median of 3 years.)
- Progression-free survival of all patients(From randomization to death or disease progression, a median of 3 years.)
- Treatment-related adverse events as assessed by NCI CTCAE v4.03(Time interval from start to 3 months after completion of radiotherapy.)
- Distant control(From randomization to distant failure, a median of 3 year.)
- Regional control(From randomization to regional failure, a median of 3 years.)