Who is sponsoring NCT01312350?

NCT01312350 is sponsored by Samsung Medical Center.

What drugs are being tested in NCT01312350?

Interventions in NCT01312350: neoadjuvant docetaxel/cisplatin/fluorouracil, No treatment before definitive CCRT.

What condition does NCT01312350 study?

NCT01312350 studies Hypopharyngeal Cancer.

Is NCT01312350 still recruiting?

NCT01312350 is currently completed. Last updated 5 December 2019.

Last reviewed 2019-12-05 · How we verify

NCT01312350

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Randomized Phase II Study

Completed Phase 2 Last updated 5 December 2019

What this trial tests

Phase 2 trial testing neoadjuvant docetaxel/cisplatin/fluorouracil in Hypopharyngeal Cancer in 40 participants. Completed in 1 December 2018.

Timeline

1 November 2010

Primary endpoint
1 March 2016

1 December 2018

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 November 2010
Primary completion	1 March 2016
Estimated completion	1 December 2018
Sites	1 location across South Korea

Drugs / interventions tested

neoadjuvant docetaxel/cisplatin/fluorouracil — full drug profile →
No treatment before definitive CCRT — full drug profile →

Conditions studied

Hypopharyngeal Cancer — all drugs for Hypopharyngeal Cancer →

Sponsor

Samsung Medical Center

Who can join

18 and older, any sex, with Hypopharyngeal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only
Time frame: 18 months after the enrollment of the last patients

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Surgery vs. radiotherapy for locally advanced hypopharyngeal cancer in the contemporary era: A population-based study.
Kim YJ, Lee R. · · 2018 · cited 30× · PMID 30479063 · DOI 10.1002/cam4.1811
Induction chemotherapy followed by concurrent chemoradiotherapy versus CCRT for locally advanced hypopharynx and base of tongue cancer.
Lim SH, Sun JM, Hong J, Oh D, et al · · 2021 · cited 7× · PMID 32241084 · DOI 10.3904/kjim.2019.161

Verify or expand the search:

Other recruiting trials for Hypopharyngeal Cancer

Currently open trials in the same condition.

NCT06039631 — Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal/Hypopharyngeal Cancer · Phase 2 · recruiting
NCT05894070 — The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer · recruiting
NCT05375266 — Immune Biomarker Study for Head and Neck Cancer · recruiting

Other Samsung Medical Center trials

Trials by the same sponsor.

NCT07482865 — Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support · NA · not yet recruiting
NCT07467213 — Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute M · Phase 4 · not yet recruiting
NCT07530913 — Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients · NA · enrolling by invitation
NCT07500701 — Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Pro · Phase 3 · recruiting
NCT07409441 — Korea Acute Myocardial Infarction Registry · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01312350 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Samsung Medical Center
Last refreshed: 5 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01312350.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing