Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)Phase 2/3RadiotherapyNCT07573956
Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies
A Phase 2/3 study testing Standard conventionally fractionated PORT and hypo-fractionated PORT in people with Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Hypo-fractionated radiotherapy reduces the OTT (overall treatment time) which may in turn reduce rapid accelerated repopulation of clonogenic cells during waiting period after surgery. If this holds true, there is a potential to achieve better loco-regional control in with PORT for HNSCC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
- What is being tested?
- Standard conventionally fractionated PORT and hypo-fractionated PORT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteIndia
- Study dates
- 10 Feb 2026to 30 Dec 2028
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pT1-4 squamous cell carcinoma of oral cavity/ oropharynx/ larynx/ hypopharynx with any of the intermediate risk features:
- Positive lymph node (s)
- Perineural invasion
- Lympho-vascular invasion
- Close margins
- Age 18-80yrs
Show all 9Show fewer
- ECOG performance status 0-1at time of surgery
- Informed consent
- Available FOR long term follow-up
Who cannot join
- High risk factors following resection: positive-margin(s)and/or extra nodal extension (ENE)
- pT1-2disease and no high-risk features (LVSI, PNI, Close margins,pN0)
- Patients receiving Neo-adjuvant or concurrent Chemotherapy
- Non-Squamous Histology
- Distant metastasis
- Synchronous or second primary malignancy outside of the oropharynx, oral cavity, larynx and hypopharynx
- Pregnant females or nursing mothers due to the probability of congenital anomalies and potential of this regimen to harm nursing infants.
- Prior Radiotherapy to head and neck region
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Dr. Aman Sharma, Associate Professor, Radiation Oncology, NCI, AIIMS
Jhajjar, Haryana
Dr. Aman Sharma, +917018529339, amans575@gmail.com
About this study
Official title: The HYPCON 3 Trial A Phase II/III Randomized Study Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant Radiation Therapy in Head and Neck Malignancies
Hypo-fractionated radiotherapy reduces the OTT (overall treatment time) which may in turn reduce rapid accelerated repopulation of clonogenic cells during waiting period after surgery. If this holds true, there is a potential to achieve better loco-regional control in with PORT for HNSCC. There is a strong radiobiological and economic rationale for delivery hypo-fractionated radiotherapy in HNSCC. The HYPCON III trial will be aimed to reduce the number of fractions by 50% (30 fr to 15 fr)
Read the detailed description
The current standard radiotherapy regimen for squamous cell carcinomas of the head and neck in the post operative setting is 60-66Gy in 30-33# delivered in 6 weeks with 5 fractions delivered per week. The aim of this study is to test whether a resource sparing, 3weeks, 15 fraction course of hypo-fractionated radiotherapy is non inferior to the conventional fractionation regimen delivering 30 fractions over6 weeks of post operative radiotherapy (PORT). Hypofractionation is already the standard of care in the treatment of cancers like breast cancer which has evolved from 50 Gy in 25 # to 40 Gy in 15# and finally to 26Gy in 5 # with similar tumor control rates and toxicity profiles.
Hypofractionation has shown promising results in prostate, lung cancer and CNS tumors. Hypofractionation has been initially explored in palliative setting for HNSCC. Unlike 2 dimensional RT deliver, recent past has seen a rapid evolution of RT delivery techniques like 3-dimensional conformal radiotherapy (3D CRT), intensity modulated radiotherapy (IMRT), image guided radiotherapy (IGRT), volumetric arc therapy (VMAT). It is now possible to spare adjoining critical organs at risk which make delivery of hypo-fractionated feasible for HNSCC. Recently, the IAEA multicentric trial in radical setting for HNSCC has proved equivalent results in term of both disease control and toxicity with delivery of hypo-fractionated RT. Shorter treatment time is more convenient to the patient. The reduction in the number of fractions required per patient will help in optimal unitization of radiotherapy resources, especially in a low/moderate income country like India where the burden of cancer hugely surpasses the resource availability. Hypo-fractionated schedules have potential to provide attractive cost benefits.
- Being tested
- Standard conventionally fractionated PORT, hypo-fractionated PORT
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard conventionally fractionated PORTRadiation
60Gy in 30 fractions over 6 weeks (5 fractions per week)
hypo-fractionated PORTRadiation
4Gy in 15 fractions over 3 weeks (5 fractions per week)
| Study group | Role | What they receive |
|---|---|---|
| Standard conventionally fractionated PORT Arm A | Active comparator | hypo-fractionated PORT Arm B Receives: Radiation: Standard conventionally fractionated PORT |
| Hypo-fractionated PORT Arm B | Experimental | Hypo-fractionated PORT Arm B Receives: Radiation: hypo-fractionated PORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
loco-regional control at 24 months
Measured: 24 months
Secondary outcomes (8)
swallowing function
using MD Anderson Dysphagia Inventory pre RT, post RT, 3, 6, 12, 18, 24 months
Measured: 2 years
Disease free survival
longitudinal assessment every 3, 6, 12, 18, 24 months
Measured: 2 years
Overall survival
longitudinal assessment every 3, 6, 12, 18, 24 months
Measured: 2 years
Quality of life EORTC QLQ C30
EORTC QLQC30 module [longitudinal assessment at 3, 6, 12, 18 and 24 months] The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 2 years
Quality of life H&N 35
EORTC H\&N 35 module [longitudinal assessment at 3, 6, 12, 18 and 24 months] The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales (maximum score 100 and minimum score 0), high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). The scoring approach for the QLQ-H\&N35 is identical in principle to that for the symptom scales / single items of the QLQ-C30.
Measured: 2 years
RTOG Acute Toxicity Post Radiation therapy
Acute toxicity is the side effects that appear within 90 days after the radiation therapy and will be assessed using RTOG acute toxicity scale with grading from 0 to IV where 0 represents no findings and IV being the worst Findings. Higher values will be showing worsening of the condition.
it will be scored weekly during radiation.
Measured: 90 days
RTOG Late toxicity post radiation therapy
late toxicity is the side effects that appear after 90 days following the radiation therapy and will be assessed using RTOG Late Radiation Morbidity Grading (Radiation Therapy Oncology Group) with maximum value of 4 showing very severe / disabling and minimum value of 0 showing no toxicity. Higher values will be showing worsening of the condition.
longitudinal assessment will be done every 3, 6, 12, 18, 24 months
Measured: 2 years
Late Toxicity using LENT- SOMA scale
using the Late effects in normal tissues- subjective, objective, management, analytic (LENT SOMA) scale.
assessment will be done at 3-, 6-and 12 months posttreatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start10 Feb 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Aman Sharma, All India Institute of Medical Sciences
- Investigators
- Dr. Aman Sharma, Principal investigator, National cancer Institute, AIIMS, Jhajjar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573956
- Sponsor's protocol ID
- AIIMSHYPCON03
- Other IDs
- I-1921
- Acronym
- Radiotherapy
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HYPCON 3 Trial A Phase II/III Randomized Study Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant Radiation Therapy in Head and Neck Malignancies
- ClinicalTrials.gov ID
- NCT07573956
- Acronym / sponsor ID
- Radiotherapy / AIIMSHYPCON03
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 7 May 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.
Hypo-fractionated radiotherapy reduces the OTT (overall treatment time) which may in turn reduce rapid accelerated repopulation of clonogenic cells during waiting period after surgery. If this holds true, there is a potential to achieve better loco-regional control in with PORT for HNSCC. There is a strong radiobiological and economic rationale for delivery hypo-fractionated radiotherapy in HNSCC. The HYPCON III trial will be aimed to reduce the number of fractions by 50% (30 fr to 15 fr)
Detailed description
The current standard radiotherapy regimen for squamous cell carcinomas of the head and neck in the post operative setting is 60-66Gy in 30-33# delivered in 6 weeks with 5 fractions delivered per week. The aim of this study is to test whether a resource sparing, 3weeks, 15 fraction course of hypo-fractionated radiotherapy is non inferior to the conventional fractionation regimen delivering 30 fractions over6 weeks of post operative radiotherapy (PORT). Hypofractionation is already the standard of care in the treatment of cancers like breast cancer which has evolved from 50 Gy in 25 # to 40 Gy in 15# and finally to 26Gy in 5 # with similar tumor control rates and toxicity profiles.
Hypofractionation has shown promising results in prostate, lung cancer and CNS tumors. Hypofractionation has been initially explored in palliative setting for HNSCC. Unlike 2 dimensional RT deliver, recent past has seen a rapid evolution of RT delivery techniques like 3-dimensional conformal radiotherapy (3D CRT), intensity modulated radiotherapy (IMRT), image guided radiotherapy (IGRT), volumetric arc therapy (VMAT). It is now possible to spare adjoining critical organs at risk which make delivery of hypo-fractionated feasible for HNSCC. Recently, the IAEA multicentric trial in radical setting for HNSCC has proved equivalent results in term of both disease control and toxicity with delivery of hypo-fractionated RT. Shorter treatment time is more convenient to the patient. The reduction in the number of fractions required per patient will help in optimal unitization of radiotherapy resources, especially in a low/moderate income country like India where the burden of cancer hugely surpasses the resource availability. Hypo-fractionated schedules have potential to provide attractive cost benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard conventionally fractionated PORT Arm A | Active comparator | Radiation: Standard conventionally fractionated PORThypo-fractionated PORT Arm B |
| Hypo-fractionated PORT Arm B | Experimental | Radiation: hypo-fractionated PORTHypo-fractionated PORT Arm B |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with pT1-4 squamous cell carcinoma of oral cavity/ oropharynx/ larynx/ hypopharynx with any of the intermediate risk features:
- Age 18-80yrs
- ECOG performance status 0-1at time of surgery
- Informed consent
- Available FOR long term follow-up
Key exclusion criteria (8 listed)
- High risk factors following resection: positive-margin(s)and/or extra nodal extension (ENE)
- pT1-2disease and no high-risk features (LVSI, PNI, Close margins,pN0)
- Patients receiving Neo-adjuvant or concurrent Chemotherapy
- Non-Squamous Histology
- Distant metastasis
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 |
|---|---|---|
| Standard conventionally fractionated PORT60Gy in 30 fractions over 6 weeks (5 fractions per week) | Radiation | Standard conventionally fractionated PORT Arm A |
| hypo-fractionated PORT4Gy in 15 fractions over 3 weeks (5 fractions per week) | Radiation | Hypo-fractionated PORT Arm B |
Primary outcome
loco-regional control at 24 months
Time frame: 24 months
8 secondary outcomes
swallowing function
Time frame: 2 years
Disease free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Quality of life EORTC QLQ C30
Time frame: 2 years
Quality of life H&N 35
Time frame: 2 years
RTOG Acute Toxicity Post Radiation therapy
Time frame: 90 days
RTOG Late toxicity post radiation therapy
Time frame: 2 years
Late Toxicity using LENT- SOMA scale
Time frame: 12 months
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 7 May 2026.
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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.
Dr. Aman Sharma principal investigator
National cancer Institute, AIIMS, Jhajjar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Standard conventionally fractionated PORT and hypo-fractionated PORT in people with Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), run by All India Institute of Medical Sciences at 1 site in India.
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 8 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dr. Aman Sharma (+917018529339, amans757@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
loco-regional control at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.