Head and Neck NeoplasmsQSSC-HNNCT07823309
Quad Shot Versus Split Course Radiotherapy in Incurable Head and Neck Cancer
A study testing Quad Shot Radiotherapy and Split Course Radiotherapy in people with Head and Neck Neoplasms and Squamous Cell Carcinoma of Head and Neck, run by Instituto Nacional de Cancerologia, Columbia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Quad Shot Radiotherapy and Split Course Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Two Hypofractionated Radiotherapy Regimens for the Palliative Management of Patients With Head and Neck Cancers: Quad Shot Versus Split Course
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.
Read the detailed description
The optimal palliative radiotherapy regimen for incurable head and neck squamous cell carcinoma remains undefined. The standard approach at the Instituto Nacional de Cancerologia is the split-course regimen. Although effective for local symptom control, it requires a prolonged treatment course and is associated with significant acute toxicities that can compromise the comfort and quality of life of frail patients with a limited life expectancy.
The Quad Shot regimen, a hypofractionated approach initially evaluated in the RTOG 8502 trial for pelvic malignancies, offers a substantially shorter treatment duration. It has shown promising symptom control and lower toxicity profiles in retrospective and early phase studies for head and neck cancers. However, there is a lack of prospective, randomized data directly comparing the Quad Shot regimen to the split course approach.
This is a single-center, open-label, exploratory phase II randomized controlled trial designed to compare the efficacy, safety, and tolerability of the Quad Shot regimen versus the split course regimen. A total of 40 adult patients will be centrally randomized in a 1:1 ratio using permuted blocks of 4, stratified by tumor volume, to receive either the experimental hypofractionated regimen or the active comparator.
To ensure data quality, the study will utilize an institutional REDCap database for electronic case report forms (eCRF) with double data entry and monthly quality control checks. Quality assurance of the radiotherapy plans will be enforced through peer review and patient-specific pre-treatment dosimetry.
A formal interim analysis for safety and futility is planned once 50% of the recruitment target is reached. Final statistical analyses will follow the Intention-To-Treat (ITT) principle. Given the palliative nature of the cohort, competitive mortality will be factored into longitudinal statistical models (such as mixed-effects models) to adequately manage missing data without distorting efficacy and quality of life estimations.
- Being tested
- Quad Shot Radiotherapy, Split Course Radiotherapy
- Keywords
- Palliative Radiotherapy, Radiation Dose Hypofractionation, Quad Shot, Split Course, Quality of Life, Cancer Pain
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quad Shot RadiotherapyRadiation
A 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 RadiotherapyRadiation
A 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.
| Study group | Role | What they receive |
|---|---|---|
| Quad Shot Regimen | Experimental | 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). Receives: Radiation: Quad Shot Radiotherapy |
| Active Comparator: Split Course Regimen | Active comparator | 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). Receives: Radiation: Split Course Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Exactly 3 months (12 weeks) from the date of randomization
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.
Measured: Baseline, at the end of radiotherapy treatment, 3 months, and 6 months from the date of randomization
Secondary 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.
Measured: From the start of treatment up to 3 months from the date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned in a 1:1 ratio using centralized randomization with permuted blocks of 4, stratified by tumor volume, to receive either the Quad Shot or the Split Course radiotherapy regimen.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia, Columbia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Oscar Gamboa, Md, Principal investigator, Instituto Nacional de Cancerologia, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823309
- Sponsor's protocol ID
- IX-023996
- Acronym
- QSSC-HN
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to strict institutional confidentiality policies and Colombian national data protection laws (Ley 1581 of 2012). Data access is strictly restricted to the authorized research team, quality monitors, and the institutional ethics committee to protect patient privacy. Only aggregated and completely anonymized summary data will be made available through scientific publications and conference presentations.
Publications
Corry 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.
PubMed 16260054
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Hypofractionated Radiotherapy Regimens for the Palliative Management of Patients With Head and Neck Cancers: Quad Shot Versus Split Course
- ClinicalTrials.gov ID
- NCT07823309
- Acronym / sponsor ID
- QSSC-HN / IX-023996
- Keywords
- Palliative Radiotherapy, Radiation Dose Hypofractionation, Quad Shot, Split Course, Quality of Life, Cancer Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia, ColumbiaOther government
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The optimal palliative radiotherapy regimen for incurable head and neck squamous cell carcinoma remains undefined. The standard approach at the Instituto Nacional de Cancerologia is the split-course regimen. Although effective for local symptom control, it requires a prolonged treatment course and is associated with significant acute toxicities that can compromise the comfort and quality of life of frail patients with a limited life expectancy.
The Quad Shot regimen, a hypofractionated approach initially evaluated in the RTOG 8502 trial for pelvic malignancies, offers a substantially shorter treatment duration. It has shown promising symptom control and lower toxicity profiles in retrospective and early phase studies for head and neck cancers. However, there is a lack of prospective, randomized data directly comparing the Quad Shot regimen to the split course approach.
This is a single-center, open-label, exploratory phase II randomized controlled trial designed to compare the efficacy, safety, and tolerability of the Quad Shot regimen versus the split course regimen. A total of 40 adult patients will be centrally randomized in a 1:1 ratio using permuted blocks of 4, stratified by tumor volume, to receive either the experimental hypofractionated regimen or the active comparator.
To ensure data quality, the study will utilize an institutional REDCap database for electronic case report forms (eCRF) with double data entry and monthly quality control checks. Quality assurance of the radiotherapy plans will be enforced through peer review and patient-specific pre-treatment dosimetry.
A formal interim analysis for safety and futility is planned once 50% of the recruitment target is reached. Final statistical analyses will follow the Intention-To-Treat (ITT) principle. Given the palliative nature of the cohort, competitive mortality will be factored into longitudinal statistical models (such as mixed-effects models) to adequately manage missing data without distorting efficacy and quality of life estimations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned in a 1:1 ratio using centralized randomization with permuted blocks of 4, stratified by tumor volume, to receive either the Quad Shot or the Split Course radiotherapy regimen.
| Arm | Type | Receives |
|---|---|---|
| Quad Shot Regimen | Experimental | Radiation: Quad Shot RadiotherapyPatients 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). |
| Active Comparator: Split Course Regimen | Active comparator | Radiation: Split Course RadiotherapyPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quad Shot RadiotherapyA 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. | Radiation | Quad Shot Regimen |
| Split Course RadiotherapyA 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. | Radiation | Active Comparator: Split Course Regimen |
Primary outcome
Objective Local Tumor Response Rate Assessed by RECIST 1.1
Time frame: Exactly 3 months (12 weeks) from the date of randomization
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.
Change in Quality of Life Assessed by FACT-H&N
Time frame: Baseline, at the end of radiotherapy treatment, 3 months, and 6 months from the date of randomization
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.
1 secondary outcome
Incidence of Acute Treatment-Related Toxicity
Time frame: From the start of treatment up to 3 months from the date of randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Results publication: PubMed 16260054Corry 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly due to strict institutional confidentiality policies and Colombian national data protection laws (Ley 1581 of 2012). Data access is strictly restricted to the authorized research team, quality monitors, and the institutional ethics committee to protect patient privacy. Only aggregated and completely anonymized summary data will be made available through scientific publications and conference presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oscar Gamboa, Md principal investigator
Instituto Nacional de Cancerologia, Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Quad Shot Radiotherapy and Split Course Radiotherapy in people with Head and Neck Neoplasms and Squamous Cell Carcinoma of Head and Neck, run by Instituto Nacional de Cancerologia, Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oscar Gamboa, Medical Doctor (+57 3112018714, ogamboa@cancer.gov.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Local Tumor Response Rate Assessed by RECIST 1.1 (time frame: Exactly 3 months (12 weeks) from the date of randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.