Clinical trial NCT02055989: A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx
Official title: A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers
Locally Advanced Thyroid Cancers
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment.
timeFrame: 12 months after radiotherapy
Secondary outcomes:
measure: Acute toxicity
timeFrame: Up to 3 months after radiotheapy
measure: Late toxicity
timeFrame: Up to 60 months after radiotherapy
measure: Local control
timeFrame: Up to 60 months after radiotherapy
measure: Loco-regional control
timeFrame: Up to 60 months after radiotherapy
measure: Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum)
timeFrame: Up to 60 months after radiotherapy
measure: Disease free survival
timeFrame: Up to 60 months after radiotherapy
measure: Overall Survival
timeFrame: Up to 60 months after radiotherapy
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Chris M Nutting, PhD
role: PRINCIPAL_INVESTIGATOR
References: