CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 285 enrolled
Drug / intervention
docetaxel +5 moredrug
Likely dose
Docetaxel 75 mg/m² on day 1 (induction phase), then 25 mg/m² on day 1 (chemoradiotherapy phase); cisplatin 75 mg/m² on day 1; fluorouracil 750 mg/m²/day days 1-5 (induction phase), then 600 mg/m²/day days 0-4 (chemoradiotherapy phase); hydroxyurea 500 mg PO q12h × 6 days per cycleAI-extracted
Key inclusion· 6
  • ✓Age 18 years or older
  • ✓Histologically or cytologically confirmed squamous cell or poorly differentiated carcinoma of head and neck (excluding lip), or lymphoepithelioma
  • ✓No prior chemotherapy or radiotherapy
  • ✓Prior surgery limited to incisional/excisional biopsy or organ-sparing procedures (debulking, neck dissection)
Key exclusion· 8
  • ✕Metastatic disease (M1)
  • ✕Severe allergic reaction to docetaxel or polysorbate 80, or similar allergies to cisplatin, 5-fluorouracil, or hydroxyurea
  • ✕Other active malignancies or malignancies diagnosed within 3 years (except basal cell carcinoma, cervical cancer in situ, or treated with ≥3 years disease-free)
  • ✕Prior surgery beyond biopsy/organ-sparing procedures, or non-biopsy procedures within 3 months of treatment start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00117572
NCT00117572Phase 3Completed
CompareCT.gov

A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer

University of Chicago·interventional·Posted Jul 7, 2005·Updated Apr 9, 2018

In Brief

A Phase 3 clinical trial evaluating docetaxel, cisplatin, and 4 other interventions for Cancer of the Pharynx and 4 related conditions. Completed, enrolled 285 participants across 26 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity, Paranasal Sinus Neoplasms, Cancer of the Oral Cavity
CountriesCroatia, France, Russia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 7, 2005
Enrollment StartNov 1, 2004
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 12.1 yearsPosted 21.0 years ago

Interventions

docetaxeldrug

75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)

cisplatindrug

75 mg/m2 on day 1

hydroxyureadrug

Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)

fluorouracildrug

750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)

chemotherapyprocedure

See protocol for details

radiotherapyprocedure

See protocol for details