CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Paclitaxel +2 moredrug
Likely dose
Paclitaxel 225 mg/m² intravenously over 3 hours on days 1 and 22; Carboplatin AUC 6 intravenously over 30 minutes on days 1 and 22; Radiotherapy 80 cGy on days 1-2 and 22-23AI-extracted
Key inclusion· 5
  • ✓Pathologically documented bulky T2 (>35 cm³), T3, or T4 squamous cell carcinoma of head and neck (no M1 disease), diagnosed within 2 months
  • ✓ECOG performance status 0, 1, or 2
  • ✓Age >18 years
  • ✓Measurable disease by MRI/CT or evaluable disease by panendoscopy
Key exclusion· 7
  • ✕Prior induction chemotherapy, prior irradiation, or prior surgery
  • ✕Metastatic disease (M1)
  • ✕Grade II or greater peripheral neuropathy
  • ✕History of malignancy at other sites within 5 years (except cervical CIS, skin cancers)

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

Search/NCT00176254
NCT00176254Phase 2Completed
CompareCT.gov

Paclitaxel, Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer

Susanne Arnold·interventional·Posted Sep 15, 2005·Updated May 16, 2023

In Brief

A Phase 2 clinical trial evaluating Radiotherapy, Paclitaxel, and 1 other intervention for Squamous Cell Carcinoma. Completed, enrolled 40 participants.

Detailed Summary

This study utilizes two cycles of Paclitaxel and Carboplatin chemotherapies followed by four small doses of radiation, prior to other treatment (surgery or radiation). This study is evaluating if radiation as a chemoenhancer increases the response rate of initial therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma
Countries--
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartMay 1, 2000
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 12.4 yearsPosted 20.8 years ago

Interventions

Radiotherapyradiation

80 centigray (cGy) on Day 1 \& 2 and 22 \& 23 of chemotherapy

Paclitaxeldrug

225 mg/m2 intravenously over three hours on Days 1 and 22

Carboplatindrug

Area under the curve (AUC) of 6 will be given intravenously over 30 minutes on days 1 and 22