Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma, or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx.

Clinical stage 0-II (AJCC, 8th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease.

Minimum age is 18 years.

ECOG Performance Status 0-2

Disqualifiers

AJCC stage III or stage IV larynx cancer

Involvement of the arytenoid cartilage beyond the vocal process.

Prior chemotherapy for treatment of the targeted larynx lesion.

Synchronous primaries in the head and neck

Trial design

Design model

Sequential

Treatments tested in this trial

  • LT-SABR

    Radiation

    42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly

  • IMRT

    Radiation

    63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2)

Treatment groups

67 Participants
are divided into 2 treatment groups
Group A: Highly conformal hypofractionated radiotherapyExperimental treatment 1 intervention
Group B: Conventional radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy.

Acute toxicity score (i.e. T score), defined as the mean number of grade 2 or higher acute toxicities experienced between the start of radiotherapy and 3 months following treatment.

Time frame
3 months following treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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