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Compares treatment options for Laryngeal Carcinoma
Official title Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy
ClinicalTrials.gov ID: NCT06080503
What this study is testing
- What it's testing
- To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma, or squamous cell variants (sarcomatoid, verrucous...
- 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...
- Minimum age is 18 years.
- ECOG Performance Status 0-2
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to...
You likely can't join if
- 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
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
- people smoking in excess of 1 pack of cigarettes per day.
See the full eligibility criteria
- 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
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days...
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
- 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
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
- people smoking in excess of 1 pack of cigarettes per day.
- people may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.