Trail Evaluating Carbon Ion Radiotherapy for Locally Recu... | NCT02569788

Studies
Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma

NCT02569788

Sponsor

Shanghai Proton and Heavy Ion Center

Status

Terminated

Last Update Posted

Feb 17, 2020Actual

Enrollment

9Actual

Phase

Phase 1Phase 2

Conditions

Nasopharyngeal Carcinoma

Interventions

Carbon ion radiotherapy (CIRT)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrual of patients.

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

May 1, 2017Actual

Completion Date

May 1, 2017Actual

First Submitted Date

Oct 1, 2015

First Submission Date that Met QC Criteria

Oct 6, 2015

First Posted Date

Oct 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2020

Last Update Posted Date

Feb 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose starting from 55GyE (2.5GyE/daily fraction) to potentially 65GyE (2.5GyE/daily fraction) to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and within 4 months after the completion of CIRT. Time-to-event continual reassessment method (TITE-CRM) is used for the phase I dose escalating part of the trial and approximately 25 patients will be accrued. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial. The Phase II part of the trial will be a single phase single arm study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CIRT Arm	Experimental	Patients included in this arm were treated with carbon ion radiotherapy (CIRT).	Radiation: Carbon ion radiotherapy (CIRT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carbon ion radiotherapy (CIRT)	Radiation	Five dose levels (55GyE, 57.5GyE, 60GyE, 62.5GyE, 65GyE) are planned within the Phase I part. Daily fraction of 2.5 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 65 GyE are safely delivered, the recommended dose (or 65 GyE) will be the prescribed dose in the Phase II part of the study. Ninty-five percent (95%) of the isodose line should cover the GTV+3~5mm.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		Time interval from the start of CIRT to 4 months after the completion of CIRT

Secondary Outcomes

Measure	Description	Time Frame
Overall survival of all patients		From the diagnosis of local recurrence of NPC, a median of 2 years
Progression-free survival of all patients		From the completion of CIRT, a median of 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed NPC
Completed a definitive course of intensity-modulated photon radiation therapy (IMXT) to a total dose of ≥ 66 Gy
Recurrence diagnosed more than 12 months after the initial course of IMXT
Age ≥ 14 and < 70 years of age
Karnofsky Performance Score ≥70
Willing to accept adequate contraception for women with childbearing potential
Ability to understand character and individual consequences of the clinical trial
Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy
Presence of distant metastasis
Technology used other than IMXT (including brachytherapy following IMXT) for the treatment of initial diagnosis of NPC
Pregnant or lactating women
Patients who have not yet recovered from acute toxicities of prior therapies
A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years
Refusal of the patient to participate into the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jiade J Lu, MD	Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Proton and Heavy Ion Center		Shanghai	Shanghai Municipality	201321	China

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D011878	Radiotherapy
D013812	Therapeutics