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Completed

NCT Number: NCT02055989

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

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

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Key information

Conditions

Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers Locally Advanced Thyroid Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck.
  • Newly diagnosed histologically confirmed papillary,follicular, undifferentiated or medullary carcinoma of the thyroid.
  • 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.
  • 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).
  • 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.
  • Stage T1-4, N1-3, M0 disease
  • Zubrod Performance Status 0-2

Exclusion criteria

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

Treatment and study plan

Dose-escalated radiotherapy level 1

Radiation

Sequential dose-escalated radiotherapy level 2

Radiation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Important dates

Study start
2002
Primary completion
2011
First posted
Feb 5, 2014
Registry last updated
Feb 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.