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NCT07823309Not yet recruiting

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 · Last updated 2 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
11 Sept 2026
Start date
1 Jan 2027
Primary completion date
31 Oct 2028
Lead sponsor
Instituto Nacional de Cancerologia, Columbia
NCT number
NCT07823309

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 1 Jan 2027 to the primary completion date, 31 Oct 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of previous radiotherapy to the same anatomical region to be treated.
  • Presence of clinical instability or severe comorbidities that contraindicate radiotherapy treatment.

Other illness

  • Diagnosis of a second active malignancy that could interfere with the evaluation of oncological outcomes.
  • Severe cognitive or psychiatric alterations that prevent the understanding of the nature of the study, signing the consent form, or adherence to the protocol.

Other

  • Women who are pregnant or breastfeeding

Who the study is looking for

  • 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.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.