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)
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
369
60Gy in 30 fractions over 6 weeks (5 fractions per week)
4Gy in 15 fractions over 3 weeks (5 fractions per week)
Dr. Aman Sharma, Associate Professor, Radiation Oncology, NCI, AIIMS
Jhajjar, Haryana, India
RECRUITINGloco-regional control at 24 months
Time frame: 24 months
swallowing function
using MD Anderson Dysphagia Inventory pre RT, post RT, 3, 6, 12, 18, 24 months
Time frame: 2 years
Disease free survival
longitudinal assessment every 3, 6, 12, 18, 24 months
Time frame: 2 years
Overall survival
longitudinal assessment every 3, 6, 12, 18, 24 months
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 12 months
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