CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 145 enrolled
Drug / intervention
carboplatin +3 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
  • Stage III or IV disease without distant metastases
  • Primary tumor sites: oral cavity (without mandible invasion), oropharynx, hypopharynx, or larynx
  • Age over 18 years
Key exclusion· 10
  • Prior chemotherapy
  • Prior radiotherapy
  • Prior surgery for this cancer (except biopsy)
  • Symptomatic peripheral neuropathy greater than grade 2

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

Search/NCT00095875
NCT00095875Phase 3Completed

A Randomized Phase III Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatinum-Based Chemoradiotherapy [PARADIGM TRIAL]

Dana-Farber Cancer Institute·interventional·Posted Nov 9, 2004·Updated Nov 19, 2013

In Brief

A Phase 3 clinical trial evaluating carboplatin, cisplatin, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 145 participants across 15 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy and radiation therapy is most effective in treating head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have stage III or stage IV head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2004
Enrollment StartAug 1, 2004
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 21.6 years ago

Interventions

carboplatindrug

Given IV

cisplatindrug

Given IV

docetaxeldrug

Given IV

fluorouracildrug

Given IV