Clinical trial · Interventional
Quad Shot Versus Split Course Radiotherapy in Incurable Head and Neck Cancer
Comparison of Two Hypofractionated Radiotherapy Regimens for the Palliative Management of Patients With Head and Neck Cancers: Quad Shot Versus Split Course
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quad Shot Radiotherapy | Radiation | — | UNRESOLVED |
| Split Course Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Quad Shot Regimen
- description
- Patients assigned to this arm will receive the experimental Quad Shot hypofractionated palliative radiotherapy regimen. Treatment is delivered using Intensity-Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT).
- interventionNames
- Radiation: Split Course Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Split Course Regimen
- description
- Patients assigned to this arm will receive the standard Split Course fractionated palliative radiotherapy regimen. Treatment is delivered using Intensity-Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT).
- interventionNames
- Radiation: Quad Shot Radiotherapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>= 18 years) 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 ECOG \<= 3. * Clinical capacity to receive radiotherapy in an outpatient setting. * Estimated life expectancy greater than 3 months. * Presence of at least one measurable lesion according to RECIST 1.1 criteria. * Logistical capacity and willingness to adhere to follow-up clinical and radiological controls up to 6 months post-treatment. * Signed informed consent. Exclusion Criteria: * 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. * Women who are pregnant or breastfeeding
References
Publications (1)
- RESULTCorry J, Peters LJ, Costa ID, Milner AD, Fawns H, Rischin D, Porceddu S. The 'QUAD SHOT'--a phase II study of palliative radiotherapy for incurable head and neck cancer. Radiother Oncol. 2005 Nov;77(2):137-42. doi: 10.1016/j.radonc.2005.10.008. Epub 2005 Nov 2. PMID 16260054