NCT03015727

Brief Summary

In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2016

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 10, 2017

Status Verified

December 1, 2016

Enrollment Period

6 years

First QC Date

December 24, 2016

Last Update Submit

January 9, 2017

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinomaInduction chemotherapyradiotherapychemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • Progress Free Survival (PFS)

    PFS means assignment to the date of any local or distant progress of the disease.

    3 years after the inception assignment

Secondary Outcomes (2)

  • Overall Survival (OS)

    3 years and 5 years after the inception of the assignment

  • Adverse Events

    Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years

Study Arms (2)

IC+RT group

EXPERIMENTAL

3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.

Drug: DocetaxelDrug: CisplatinRadiation: IMRT/TOMO

IC+CCRT group

ACTIVE COMPARATOR

3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.

Drug: DocetaxelDrug: CisplatinRadiation: IMRT/TOMODrug: Chemotherapy

Interventions

DocetaxelDRUG

3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.

Also known as: DOC
IC+CCRT groupIC+RT group
CisplatinDRUG

3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.

Also known as: DDP
IC+CCRT groupIC+RT group
IMRT/TOMORADIATION

intensity modulated radiation therapy or tomotherapy

IC+CCRT groupIC+RT group
ChemotherapyDRUG

2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.

Also known as: concurrent chemotherapy
IC+CCRT group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly histologically confirmed non-keratinizing carcinoma.
  • Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)
  • No evidence of distant metastasis (M0)
  • Performance status: KPS\>70
  • With normal liver function test (ALT, AST \<1.5ULN)
  • Renal: creatinine clearance \>60ml/min
  • Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
  • With controlled blood glucose for diabetes patients
  • Written informed consent
  • satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)

You may not qualify if:

  • WHO type I squamous cell carcinoma or adenocarcinoma
  • Age \>65 or \<18
  • With a history of renal disease
  • Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
  • Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
  • Patient is pregnant or lactating
  • Peripheral neuropathy
  • Emotional disturbance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaozhong Chen

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

DocetaxelCisplatinDrug Therapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • Xiaozhong Chen

    Zhejiang Cancer Hospital

    STUDY CHAIR

Central Study Contacts

Xiaozhong Chen

CONTACT

cxzfyun@sina.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2016

First Posted

January 10, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2024

Last Updated

January 10, 2017

Record last verified: 2016-12

Locations

CN(1)