Quad Shot Radiotherapy in Combination With Immune Checkpoint Inhibition (NCT04454489) | Clinical Trial Compass
CompletedPhase 2
Quad Shot Radiotherapy in Combination With Immune Checkpoint Inhibition
United States21 participantsStarted 2021-02-25
Plain-language summary
This is a single-arm, non-randomized pilot study to evaluate the efficacy and tolerability of combination quad-shot palliative radiotherapy with immunotherapy for advanced/recurrent/metastatic head and neck cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Advanced, recurrent or metastatic head and neck squamous cell carcinoma, as defined by clinical or pathological diagnosis of any of the following:
* Locally advanced head and neck squamous cell carcinoma not suitable for curative local treatment.
* Locally recurrent head and neck squamous cell carcinoma not suitable for curative local treatment within or outside a previously irradiated tissue.
* Metastatic head and neck squamous cell carcinoma.
* Target site in the head and neck region amenable to quad-shot palliative radiotherapy, for which palliative radiotherapy is recommended, as determined by the treating radiation oncologist.
* Age 18 years or greater at time of registration.
* ECOG Performance Status of 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 and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
* Willingness to provide blood and saliva samples for exploratory research purposes.
* Organ and Marrow Function as defined below: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 9.0 g/dL, serum bili…