Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
Conditions
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)
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.
Interventions
RADIATIONStandard conventionally fractionated PORT
60Gy in 30 fractions over 6 weeks (5 fractions per week)
RADIATIONhypo-fractionated PORT
4Gy in 15 fractions over 3 weeks (5 fractions per week)
Sponsors
All India Institute of Medical Sciences
Indian Council of Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| loco-regional control at 24 months | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| swallowing function | 2 years | using MD Anderson Dysphagia Inventory pre RT, post RT, 3, 6, 12, 18, 24 months |
| Disease free survival | 2 years | longitudinal assessment every 3, 6, 12, 18, 24 months |
| Overall survival | 2 years | longitudinal assessment every 3, 6, 12, 18, 24 months |
| Quality of life EORTC QLQ C30 | 2 years | 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. |
| Quality of life H&N 35 | 2 years | 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. |
| RTOG Acute Toxicity Post Radiation therapy | 90 days | 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. |
| RTOG Late toxicity post radiation therapy | 2 years | 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 |
| Late Toxicity using LENT- SOMA scale | 12 months | 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. |
Countries
India
Contacts
CONTACTDr. Aman Sharma
PRINCIPAL_INVESTIGATORDr. Aman Sharma
National cancer Institute, AIIMS, Jhajjar
Outcome results
None listed