Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055989
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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


Condition or disease Intervention/treatment Phase
Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers Locally Advanced Thyroid Cancers Radiation: Dose-escalated radiotherapy level 1 Radiation: Sequential dose-escalated radiotherapy level 2 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx
Study Start Date : January 2002
Actual Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose-escalated radiotherapy level 1 Radiation: Dose-escalated radiotherapy level 1
Experimental: Sequential dose-escalated radiotherapy level 2 Radiation: Sequential dose-escalated radiotherapy level 2



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Acute toxicity [ Time Frame: Up to 3 months after radiotheapy ]
  2. Late toxicity [ Time Frame: Up to 60 months after radiotherapy ]
  3. Local control [ Time Frame: Up to 60 months after radiotherapy ]
  4. Loco-regional control [ Time Frame: Up to 60 months after radiotherapy ]
  5. Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum) [ Time Frame: Up to 60 months after radiotherapy ]
  6. Disease free survival [ Time Frame: Up to 60 months after radiotherapy ]
  7. Overall Survival [ Time Frame: Up to 60 months after radiotherapy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Newly diagnosed histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck.
  2. Newly diagnosed histologically confirmed papillary,follicular, undifferentiated or medullary carcinoma of the thyroid.
  3. Tumours arising from the oral larynx or hypopharynx requiring radical radiation of the primary tumour by parallel opposed lateral fields, and bilateral cervical lymph node irradiation.
  4. High risk of radiation induced xerostomia with conventional radiotherapy due to the irradiation of the majority of both parotid glands (defined as estimated mean dose to both parotid glands greater than 26 Gy using conventional radiotherapy technique).
  5. Radiotherapy either as primary therapy or post-operative (only for thyroid carcinoma). Techniques to be detailed by each centre. Neo-adjuvant and concomitant chemotherapy are permitted.
  6. Stage T1-4, N1-3, M0 disease
  7. Zubrod Performance Status 0-2

Exclusion Criteria:

  1. Previous radiotherapy to the head and neck region
  2. Previous malignancy except non-melanoma skin cancer
  3. Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
  4. Prophylactic use of amifostine or pilocarpine is not allowed
  5. Brachytherapy is not allowed as part of the treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055989


Locations
Layout table for location information
United Kingdom
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Chris M Nutting, PhD Royal Marsden NHS Foundation Trust

Layout table for additonal information
Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02055989    
Other Study ID Numbers: CCR 1978
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Laryngeal Diseases
Thyroid Diseases
Endocrine System Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma