PILOT Phase of a trial looking at benefits of Hyperfractionated IMRT in locally advanced head and neck cancer.

PILOT phase of a single arm phase II trial to assess the toxicity and efficacy of hyper-fractionated IMRT (Intensity Modulated Radiotherapy) in radical treatment of locally advanced head and neck squamous cell carcinoma.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000428

Enrollment

Registered

2010-06-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Hyperfractionated IMRT: Radiotherapy divided in to two fractions per day for 33 days achieve a total dose of 7920cGY Control Intervention1: Historical control: Standard fractionation of

Eligibility

Inclusion criteria

Inclusion criteria: Age < 70 yrs Squamous cell carcinoma of oropharynx or hypopharynx T3, T4 and N0 or N+ and M0 / Stage III & Stage IV A and B ECOG/ Performance score of 1 and 2 Hb > 8.0 mg/dL

Exclusion criteria

Exclusion criteria: History of prior irradiation to the loco-regional site History of prior surgery or chemotherapy ECOG/ Performance score of > 2 Prior and concomitant associated diseases which are contraindications to radiotherapy like connective tissue disorders. Hb < 8.0 mg/dL Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Design outcomes

Primary

Measure	Time frame
To determine whether Hyper fractionated IMRT in locally advanced T3 T4, N0 N+ squamous cell carcinoma of the oropharynx and hypopharynx leads to a reduction in acute toxicity as compared to the historical data from the standard fractionated intensity modulated chemo-radiotherapy.Timepoint: Week 1,2, 3 4 , 5, 6th, 6th week post radiotherapy, 6th month and end of first year	—

Secondary

Measure	Time frame
econdary Outcome Timepoints ? To evaluate the incidence of late effects, grade 3 and 4 Xerostomia and dysphagia during the first year following the treatment evaluated using CTC AE v 3.0. ? To assess the Quality of life (QoL) using EORTC head and neck module for QoL ? To assess the loco regional control at the end of first year following completion of therapy.Timepoint: Week 1,2, 3 4 , 5, 6th, 6th week post radiotherapy, 6th month and end of first year	—

Measure

Time frame

econdary Outcome Timepoints ? To evaluate the incidence of late effects, grade 3 and 4 Xerostomia and dysphagia during the first year following the treatment evaluated using CTC AE v 3.0. ? To assess the Quality of life (QoL) using EORTC head and neck module for QoL ? To assess the loco regional control at the end of first year following completion of therapy.Timepoint: Week 1,2, 3 4 , 5, 6th, 6th week post radiotherapy, 6th month and end of first year

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Countries

India

Contacts

Public ContactBalu Krishna S

Tamil Nadu Medical council

drbalunair@gmail.com04162283145

Outcome results