Clinical Trial: A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx

Brief Summary:

This study is a phase I/II dose escalation trial designed to test the feasibility of delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety and possible improvement in outcome when the dose is increased.

This protocol is in fact two studies running in parallel: thyroid cancer patients and larynx/ hypopharynx cancer patients. These two groups of patients are being treated differently and will be analysed separately.

The primary objective of this Phase I sequential cohort study was to determine the feasibility of delivering modest acceleration and dose-escalated IMRT in locally advanced high-risk thyroid cancers. We report the incidence and prevalence of acute toxicities of 2 dose fractionation regimens.

DL1: primary site 58.8 Gy in 28 daily fractions and nodal levels 50 Gy in 28 daily fractions

DL2: primary 66.6 Gy in 30 daily fractions and post operative nodal levels 60 Gy in 30 daily fractions and elective nodal levels 54 Gy in 30 daily fractions


Detailed Summary:
Sponsor: Royal Marsden NHS Foundation Trust

Current Primary Outcome: The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment. [ Time Frame: 12 months after radiotherapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Acute toxicity [ Time Frame: Up to 3 months after radiotheapy ]
  • Late toxicity [ Time Frame: Up to 60 months after radiotherapy ]
  • Local control [ Time Frame: Up to 60 months after radiotherapy ]
  • Loco-regional control [ Time Frame: Up to 60 months after radiotherapy ]
  • Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum) [ Time Frame: Up to 60 months after radiotherapy ]
  • Disease free survival [ Time Frame: Up to 60 months after radiotherapy ]
  • Overall Survival [ Time Frame: Up to 60 months after radiotherapy ]


Original Secondary Outcome: Same as current

Information By: Royal Marsden NHS Foundation Trust

Dates:
Date Received: February 4, 2014
Date Started: January 2002
Date Completion:
Last Updated: February 4, 2014
Last Verified: February 2014