Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)

This study is currently recruiting participants.

Verified March 2011 by Samsung Medical Center

Sponsor:

Information provided by:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01312350

First received: February 21, 2011

Last updated: March 8, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 21, 2011

Last Updated Date

March 8, 2011

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

August 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01312350 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only [ Time Frame: 18 months after enrollemnt of last patients ] [ Designated as safety issue: No ]
To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only [ Time Frame: 18 months after the enrollment of the last patient ] [ Designated as safety issue: No ]
To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only [ Time Frame: 18 months after the enrollment of the last patient ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypopharyngeal Cancer

Intervention ^ICMJE

Drug: neoadjuvant docetaxel/cisplatin/fluorouracil
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.

Other Name: Docetaxel (taxotere)
Drug: No treatment before definitive CCRT
concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43

Study Arm (s)

Active Comparator: CCRT only arm
no neoadjuvant chemotherapy before definitive CCRT

Intervention: Drug: No treatment before definitive CCRT
Experimental: neoadjuvant chemotherapy arm
2 cycles of TPF chemotherapy before definitive CCRT

Intervention: Drug: neoadjuvant docetaxel/cisplatin/fluorouracil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Not Provided

Estimated Primary Completion Date

August 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Distant metastasis
Other malignancy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Keunchil Park, Pf

82-2-3410-3459

kpark@skku.edu

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01312350

Other Study ID Numbers ^ICMJE

2010-10-028

Has Data Monitoring Committee

Responsible Party

Keunchil Park/Professor, Samsung Medical Center

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Samsung Medical Center

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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