Quad Shot Versus Split Course Radiotherapy in Incurable Head and Neck Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Nacional de Cancerologia, Columbia
About this trial
Head and neck cancer in its advanced, incurable stage causes severe symptoms such as pain, trouble swallowing, and bleeding. Palliative radiation therapy is frequently used to relieve these symptoms and improve the patient's quality of life. Currently, a standard treatment approach is the "Split Course" regimen, which takes several weeks and can cause side effects that are difficult for patients to tolerate. This study aims to evaluate a shorter, alternative radiation treatment called "Quad Shot."
The hypothesis of this study is that the Quad Shot regimen will be as effective as the Split Course regimen in shrinking the tumor and controlling local symptoms, but will offer a better quality of life by reducing the overall treatment time and the severity of side effects. To test this, researchers will assign participants by chance to receive either the Quad Shot or the Split Course regimen. The research team will closely monitor tumor response, treatment side effects, and patients' quality of life for up to six months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (18 years and older) with a histopathological diagnosis of incurable squamous cell carcinoma of the head and neck, not candidates for curative-intent treatment.
Metastatic or locally advanced unresectable disease, in a strictly palliative setting.
Medical indication for palliative radiotherapy.
Performance status: Karnofsky 50 or higher or ECOG 3 or lower.
Disqualifiers
History of previous radiotherapy to the same anatomical region to be treated.
Diagnosis of a second active malignancy that could interfere with the evaluation of oncological outcomes.
Presence of clinical instability or severe comorbidities that contraindicate radiotherapy treatment.
Severe cognitive or psychiatric alterations that prevent the understanding of the nature of the study, signing the consent form, or adherence to the protocol.
Trial design
Design model
Parallel
Treatments tested in this trial
Quad Shot Radiotherapy
RadiationA hypofractionated palliative radiotherapy regimen delivering a dose of 14.8 Gy divided into 4 fractions. Each fraction is 3.7 Gy, administered twice a day (with an interval of at least 6 hours between fractions) for 2 consecutive days. This cycle can be repeated up to three times with a resting interval of 3 to 4 weeks between each cycle, provided there is no limiting toxicity or disease progression.
Split Course Radiotherapy
RadiationA fractionated palliative radiotherapy regimen administered in two phases. The total dose is 60 Gy divided into 20 daily fractions of 3 Gy each. A planned resting interval of 3 to 4 weeks is introduced between the two treatment phases to maximize symptom control while maintaining acceptable toxicity.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Quad Shot RegimenExperimental treatment 1 intervention
Group B: Active Comparator: Split Course RegimenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Objective Local Tumor Response Rate Assessed by RECIST 1.1
The proportion of patients achieving an objective local tumor response, defined as either a Complete Response (CR) or a Partial Response (PR), evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame
Exactly 3 months (12 weeks) from the date of randomization2
Change in Quality of Life Assessed by FACT-H&N
Mean change from baseline in patient-reported quality of life, measured by the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\&N) questionnaire. The FACT-H\&N assesses physical, social/family, emotional, and functional well-being, along with head and neck specific concerns. The total score ranges from 0 to 156, where higher scores indicate a better quality of life Assessment of Cancer Therapy-Head and Neck (FACT-H\&N) questionnaire. The FACT-H\&N assesses physical, social/family, emotional, and functional well-being, along with head and neck specific concerns. Higher scores indicate a better quality of life.
Time frame
Baseline, at the end of radiotherapy treatment, 3 months, and 6 months from the date of randomizationSecondary outcomes
1
Incidence of Acute Treatment-Related Toxicity
The proportion of patients experiencing acute adverse events (Grade 2 or higher) associated with the radiotherapy regimens. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
From the start of treatment up to 3 months from the date of randomizationOther outcomes
1
Incidence of Late Treatment-Related Toxicity
The proportion of patients experiencing new or persistent late adverse events (Grade 2 or higher) associated with the radiotherapy regimens. Toxicities will be graded according to the CTCAE version 5.0.
Time frame
At 3 months and 6 months from the date of randomization2
Treatment Feasibility and Tolerance
The proportion of patients who successfully complete the prescribed radiotherapy regimen, defined as receiving 90% or more of the planned radiation dose/fractions without treatment abandonment, major modifications, or unscheduled interruptions longer than 7 consecutive days due to toxicity or clinical deterioration.
Time frame
Through the completion of the prescribed radiotherapy regimen, an average of 4 to 8 weeks3
Overall Survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients alive at the end of their follow-up period will be censored.
Time frame
Up to 6 months from the date of randomizationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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