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New treatment option for Locally Advanced Head-and-Neck Cancer
Official title Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer
ClinicalTrials.gov ID: NCT04185974
What this study is testing
- What it's testing
- After multimodal therapy of head-and-neck tumors, patients often develop local recurrence, locally progressive disease or second primary tumors. In this highly pre-treated patient cohort, therapeutic options are limited.
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
- Locally recurrent / progressive head-and-neck cancer after initial radiation therapy
- Microscopic or macroscopic tumor after salvage surgery
- Indication for re-irradiation
- Completed wound healing after surgical intervention
- Karnofsky-Performance-Score ≥ 60
You likely can't join if
- Re-irradiation of malignancy in the larynx
- Diagnosed plasmocytoma, sarcoma or chordoma
- Previous re-irradiation in-field
- Time interval \< 6 months after initial radiotherapy
- Distant metastases (except pulmonary metastases)
- Patients who have not recovered from acute toxicities of prior therapies
See the full eligibility criteria
- Locally recurrent / progressive head-and-neck cancer after initial radiation therapy
- Microscopic or macroscopic tumor after salvage surgery
- Indication for re-irradiation
- Completed wound healing after surgical intervention
- Karnofsky-Performance-Score ≥ 60
- Age ≥ 18 years
- Written informed consent (must be available before enrolment in the trial)
- Ability of subject to understand character and individual consequences of the trial
- For women with childbearing potential, (and men) adequate contraception
- Submission of previous radiotherapy records
- Re-irradiation of malignancy in the larynx
- Diagnosed plasmocytoma, sarcoma or chordoma
- Previous re-irradiation in-field
- Time interval \< 6 months after initial radiotherapy
- Distant metastases (except pulmonary metastases)
- Patients who have not recovered from acute toxicities of prior therapies
- Refusal of the patients to take part in the study
- Pregnant or lactating women
- Known carcinoma \<5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- Participation in another clinical study or observation period of competing trials, respectively
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Germany
- Marburg, Germany
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 Heidelberg, Germany; Marburg, Germany. 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.