CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
cisplatin +2 moredrug
Likely dose
Cisplatin 100 mg/m² IV on days 1, 22, 43 and 80 mg/m² IV on days 71, 99, 127; Fluorouracil 1000 mg/m²/day as 96-hour continuous infusion on days 71-74, 99-102, 127-130; IMRT 70 Gy in 33 fractions at 2.12 Gy per fractionAI-extracted
Key inclusion· 8
  • ✓Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx (WHO I-III)
  • ✓No evidence of distant metastasis
  • ✓Measurable or evaluable disease
  • ✓Age 18 and over
Key exclusion· 7
  • ✕Stage IVC disease
  • ✕Evidence of distant metastasis
  • ✕Prior head and neck cancer
  • ✕Malignancy within past 5 years except nonmelanoma skin cancer

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

Search/NCT00057785
NCT00057785Phase 2Completed
CompareCT.gov

A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer

Radiation Therapy Oncology Group·interventional·Posted Apr 9, 2003·Updated Feb 17, 2017

In Brief

A Phase 2 clinical trial evaluating cisplatin, fluorouracil, and 1 other intervention for Head and Neck Cancer and 2 related conditions. Completed, enrolled 68 participants across 17 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Oral Complications of Radiation Therapy, Radiation Toxicity
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartFeb 1, 2003
Primary CompletionFeb 1, 2007
Study CompletionDec 1, 2016
TodayJul 1, 2026
Enrollment to primary: 4 yearsPosted 23.2 years ago

Interventions

cisplatindrug

100 mg/m\^2 intravenously on days 1, 22, and 43 and 80 mg/m\^2 intravenously on days 71, 99, and 127

fluorouracildrug

1000 mg/m\^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130

Intensity modulated radiation therapyradiation

The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume \[CTV\] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.