Suspended
Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study
What is being tested
Adjuvant chemotherapy with paclitaxel and nedaplatin
Drug
Who is being recruted
Carcinoma+11
+ Head and Neck Neoplasms
+ Stomatognathic Diseases
From 18 to 65 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: September 2012
Summary
Principal SponsorJiangsu Cancer Institute & Hospital
Last updated: June 15, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?
Principal SponsorJiangsu Cancer Institute & Hospital
Last updated: June 15, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
CarcinomaHead and Neck NeoplasmsStomatognathic DiseasesNasopharyngeal DiseasesNasopharyngeal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal DiseasesPharyngeal NeoplasmsNasopharyngeal Carcinoma
Criteria
5 inclusion criteria required to participate
ECOG <= 2
age: 18y - 65y
pathologically confirmed untreated NPC patients staged N2-3M0
with MRI examinations
Show More Criteria
5 exclusion criteria prevent from participating
could not staged properly
pregnancy
with other severe diseases(blood,liver ,kidney or heart diseases)
without a second cancer
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPatients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
Group II
No InterventionPatients will be followed up without adjuvant chemotherapy after concurrent chemoradiation
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center