Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies (Radiotherapy)
The HYPCON 3 Trial A Phase II/III Randomized Study Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant Radiation Therapy in Head and Neck Malignancies
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Dr. Aman Sharma
- Telefonnummer: +917018529339
- E-post: amans757@gmail.com
Studiesteder
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Haryana
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Jhajjar, Haryana, India
- Rekruttering
- Dr. Aman Sharma, Associate Professor, Radiation Oncology, NCI, AIIMS
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Ta kontakt med:
- Dr. Aman Sharma
- Telefonnummer: +917018529339
- E-post: amans575@gmail.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Standard conventionally fractionated PORT Arm A
hypo-fractionated PORT Arm B
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60Gy in 30 fractions over 6 weeks (5 fractions per week)
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Eksperimentell: Hypo-fractionated PORT Arm B
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4Gy in 15 fractions over 3 weeks (5 fractions per week)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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loco-regional control at 24 months
Tidsramme: 24 months
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24 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Samlet overlevelse
Tidsramme: 2 år
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longitudinal vurdering hver 3., 6., 12., 18., 24. måned
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2 år
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Livskvalitet EORTC QLQ C30
Tidsramme: 2 år
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EORTC QLQ-C30-modul [langsgående vurdering ved 3, 6, 12, 18 og 24 måneder] QLQ-C30 består av både flergjenstandsskalaer og enkeltgjenstandsmål. Disse inkluderer fem funksjonsskalaer, tre symptomskalaer, en global helsetilstand-/livskvalitetsskala og seks enkeltgjenstander. Hver av flergjenstandsskalene inkluderer et forskjellig sett med gjenstander – ingen gjenstand forekommer i mer enn én skala. Alle skalaene og enkeltgjenstandsmålene har en skåre som varierer fra 0 til 100. En høy skålaskår representerer et høyere responsnivå. Høy skår på en funksjonsskala representerer et høyt/friskt funksjonsnivå, høy skår på global helsetilstand/livskvalitet representerer høy livskvalitet, men høy skår på en symptomskala/gjenstand representerer et høyt symptomnivå/problemer. |
2 år
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swallowing function
Tidsramme: 2 years
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using MD Anderson Dysphagia Inventory pre RT, post RT, 3, 6, 12, 18, 24 months
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2 years
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Disease free survival
Tidsramme: 2 years
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longitudinal assessment every 3, 6, 12, 18, 24 months
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2 years
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Quality of life H&N 35
Tidsramme: 2 years
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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.
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2 years
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RTOG Acute Toxicity Post Radiation therapy
Tidsramme: 90 days
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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. |
90 days
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RTOG Late toxicity post radiation therapy
Tidsramme: 2 years
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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 |
2 years
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Late Toxicity using LENT- SOMA scale
Tidsramme: 12 months
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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. |
12 months
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dr. Aman Sharma, National cancer Institute, AIIMS, Jhajjar
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AIIMSHYPCON03
- I-1921 (Annen identifikator: ICMR)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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