Brief Summary

The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

285

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Nov 2004

Longer than P75 for phase_3

Geographic Reach

5 countries

26 active sites

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

12.1 years study duration

Study Start

First participant enrolled

November 1, 2004

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed

7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2005

Completed

11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

April 9, 2018

Completed

Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

12.1 years

First QC Date

June 30, 2005

Results QC Date

February 26, 2018

Last Update Submit

April 6, 2018

Conditions

Cancer of the Pharynx Cancer of the Larynx Cancer of the Nasal Cavity Paranasal Sinus Neoplasms Cancer of the Oral Cavity

Keywords

Cancer of the Pharynx (Nasopharynx, Oropharynx, Hypopharynx)Cancer of the Nasal Cavity and Paranasal Sinuses

Outcome Measures

Primary Outcomes (1)

Overall Survival: Time From Randomization to Death From Any Cause
Survival rates over 6 years.
Up to 6 years

Secondary Outcomes (12)

Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
Up to 6 years
Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
Up to 6 years
Failure Pattern (Local/Regional Recurrence)
Up to 6 years
Failure Pattern (Distant Recurrence)
Up to 6 years
Quality of Life (FACT H&N)
Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
+7 more secondary outcomes

Study Arms (2)

Induction plus chemoradiotherapy

ACTIVE COMPARATOR

Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.

Drug: docetaxelDrug: cisplatinDrug: hydroxyureaDrug: fluorouracilProcedure: chemotherapyProcedure: radiotherapy

Chemoradiotherapy

ACTIVE COMPARATOR

Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.

Drug: docetaxelDrug: hydroxyureaDrug: fluorouracilProcedure: chemotherapyProcedure: radiotherapy