NCT01312350

Brief Summary

The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III \& IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

5.3 years

First QC Date

February 21, 2011

Last Update Submit

December 5, 2019

Conditions

Hypopharyngeal Cancer

Keywords

neoadjuvant chemotherapydefinitive chemoradiation therapyhead and neck cancerbase of tongueLocally advanced

Outcome Measures

Primary Outcomes (1)

  • To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only

    18 months after the enrollment of the last patients

Secondary Outcomes (3)

  • To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only

    18 months after enrollemnt of last patients

  • To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only

    18 months after the enrollment of the last patient

  • To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only

    18 months after the enrollment of the last patient

Study Arms (2)

CCRT only arm

ACTIVE COMPARATOR

no neoadjuvant chemotherapy before definitive CCRT

Drug: No treatment before definitive CCRT

neoadjuvant chemotherapy arm

EXPERIMENTAL

2 cycles of TPF chemotherapy before definitive CCRT

Drug: neoadjuvant docetaxel/cisplatin/fluorouracil

Interventions

neoadjuvant docetaxel/cisplatin/fluorouracilDRUG

2 cycles of neoadjuvant Docetaxel/cisplatin/5-fluorouracil therapy followed by CCRT Neoadjuvant chemotherapy (docetaxel 75mg/m2 D1, cisplatin 75mg/m2 D1, 5-fluoruracil 759mg/m2/day, D1-4, every 3 weeks) CCRT protocol is same with that of control arm.

Also known as: Docetaxel (taxotere)
neoadjuvant chemotherapy arm
No treatment before definitive CCRTDRUG

concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43

CCRT only arm

Eligibility Criteria

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

You may qualify if:

  • Histologically/cytologically proven stage III/IVM0 hypopharyngeal or base of tongue cancer
  • One or more evaluable or measurable lesion
  • No prior chemotherapy, radiation, or surgery
  • ECOG 0-2

You may not qualify if:

  • Distant metastasis
  • Other malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Hypopharyngeal NeoplasmsHead and Neck Neoplasms

Interventions

CF regimenDocetaxel

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

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
Principal investigator

Study Record Dates

First Submitted

February 21, 2011

First Posted

March 10, 2011

Study Start

November 1, 2010

Primary Completion

March 1, 2016

Study Completion

December 1, 2018

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations

KR(1)