NCT07573956

Brief 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. 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for phase_2

Timeline
32mo left

Started Feb 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026Dec 2028

Study Start

First participant enrolled

February 10, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2.4 years

First QC Date

April 28, 2026

Last Update Submit

May 5, 2026

Conditions

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Outcome Measures

Primary Outcomes (1)

  • loco-regional control at 24 months

    24 months

Secondary Outcomes (8)

  • swallowing function

    2 years

  • Disease free survival

    2 years

  • Overall survival

    2 years

  • Quality of life EORTC QLQ C30

    2 years

  • Quality of life H&N 35

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Standard conventionally fractionated PORT Arm A

ACTIVE COMPARATOR

hypo-fractionated PORT Arm B

Radiation: Standard conventionally fractionated PORT

Hypo-fractionated PORT Arm B

EXPERIMENTAL

Hypo-fractionated PORT Arm B

Radiation: hypo-fractionated PORT

Interventions

Standard conventionally fractionated PORTRADIATION

60Gy in 30 fractions over 6 weeks (5 fractions per week)

Standard conventionally fractionated PORT Arm A
hypo-fractionated PORTRADIATION

4Gy in 15 fractions over 3 weeks (5 fractions per week)

Hypo-fractionated PORT Arm B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • ECOG performance status 0-1at time of surgery
  • Informed consent
  • Available FOR long term follow-up

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Aman Sharma, Associate Professor, Radiation Oncology, NCI, AIIMS

Jhajjar, Haryana, India

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Dr. Aman Sharma

    National cancer Institute, AIIMS, Jhajjar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Aman Sharma

CONTACT

+917018529339amans757@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 7, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations

IN(1)