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Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies

ConditionSquamous Cell Carcinoma Head and Neck Cancer (HNSCC)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAll India Institute of Medical Sciences

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Positive lymph node (s)

Perineural invasion

Lympho-vascular invasion

Close margins

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard conventionally fractionated PORT

    Radiation

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

  • hypo-fractionated PORT

    Radiation

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

Treatment groups

369 Participants
are divided into 2 treatment groups
Group A: Standard conventionally fractionated PORT Arm AActive comparator 1 intervention
Group B: Hypo-fractionated PORT Arm BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

loco-regional control at 24 months

Time frame
24 months

Secondary outcomes

1

swallowing function

using MD Anderson Dysphagia Inventory pre RT, post RT, 3, 6, 12, 18, 24 months

Time frame
2 years
2

Disease free survival

longitudinal assessment every 3, 6, 12, 18, 24 months

Time frame
2 years
3

Overall survival

longitudinal assessment every 3, 6, 12, 18, 24 months

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

All India Institute of Medical Sciences

Lead sponsor

Indian Council of Medical Research

Collaborator

Source ClinicalTrials.gov
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