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Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Photon

Proton

Carbon ion

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, Intensity-modulated radiation therapy, Proton beam therapy, Carbon-ion radiotherapy, Toxicity, Survival, Disease control

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Photon combined with Carbon ion

Proton combined with Carbon ion

Arm Description

The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.

The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

Overall survival of all patients

Progression-free survival of all patients

Local control

Regional control

Distant control

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

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

Full Information

NCT ID

NCT04528394

First Posted

August 24, 2020

Last Updated

August 24, 2020

Sponsor

Shanghai Proton and Heavy Ion Center

1. Study Identification

Unique Protocol Identification Number

NCT04528394

Brief Title

Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 29, 2019 (Actual)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Proton and Heavy Ion Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, Intensity-modulated radiation therapy, Proton beam therapy, Carbon-ion radiotherapy, Toxicity, Survival, Disease control

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Photon combined with Carbon ion

Arm Type

Experimental

Arm Description

The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.

Arm Title

Proton combined with Carbon ion

Arm Type

Experimental

Arm Description

The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.

Intervention Type

Radiation

Intervention Name(s)

Photon

Intervention Description

Photon combined with Carbon ion in Arm 1

Intervention Type

Radiation

Intervention Name(s)

Proton

Intervention Description

Proton combined with Carbon ion in Arm 2

Intervention Type

Radiation

Intervention Name(s)

Carbon ion

Intervention Description

Same dose and fractionation will be used in both arms.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall survival of all patients

Time Frame

From randomization to death, a median of 3 years.

Title

Progression-free survival of all patients

Time Frame

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

Title

Local control

Time Frame

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

Title

Regional control

Time Frame

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

Title

Distant control

Time Frame

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

Title

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

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type). Age ≥ 18 and ≤ 70 years of age. Eastern Cooperative Oncology Group score: 0-1. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lin Kong, MD

Phone

133XXX

lin.kong@sphic.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jiyi Hu, MD

Phone

1333XXX

jiyi.hu@sphic.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiade Lu, MD

Organizational Affiliation

Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Proton and Heavy Ion Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201315

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lin Kong, MD

lin.kong@sphic.org.cn

First Name & Middle Initial & Last Name & Degree

Jiyi Hu, MD

jiyi.hu@sphic.org.cn

First Name & Middle Initial & Last Name & Degree

Jiade J Lu, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.

IPD Sharing Time Frame

Within 5 years after the publication of the study

IPD Sharing Access Criteria

Data may be shared with radiation oncologists who are interested in examining the efficacy and toxicity of nasopharyngeal carcinoma patients treated with particle beam radiotherapy. Pooled analysis comparing IMRT and particle beam radiotherapy will be of particular interest. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

Learn more about this trial

Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

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