NCT01694576

Brief Summary

By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

September 17, 2012

Last Update Submit

June 12, 2015

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma staged N2-3M0Adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • treatment toxicity based on a CTCAE3.0 grading system

    6 months

Secondary Outcomes (1)

  • progress free survival

    24 months

Other Outcomes (1)

  • distant metastasis free survival

    24 months

Study Arms (2)

Adjuvant chemotherapy with paclitaxel and nedaplatin

EXPERIMENTAL

Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation

Drug: Adjuvant chemotherapy with paclitaxel and nedaplatin

Observation

NO INTERVENTION

Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation

Interventions

Adjuvant chemotherapy with paclitaxel and nedaplatinDRUG

Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation

Also known as: Adjuvant chemotherapy
Adjuvant chemotherapy with paclitaxel and nedaplatin

Eligibility Criteria

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

You may qualify if:

  • pathologically confirmed untreated NPC patients staged N2-3M0
  • age: 18y - 65y
  • with MRI examinations
  • ECOG≤2
  • with written consent

You may not qualify if:

  • without a second cancer
  • pregnancy
  • with other severe diseases(blood,liver ,kidney or heart diseases)
  • could not staged properly
  • without written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Chemotherapy, AdjuvantPaclitaxelnedaplatin

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)

Combined Modality TherapyTherapeuticsDrug TherapyTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Xia He, M.D. and PhD

    Department of Radiotherapy,Jiangsu Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the department of radiotherapy

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 27, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations

CN(1)