Neoplasms

All Conditions

Rare Diseases

Medulloblastoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

1.8 Gy daily, 5 fractions per week

Cranio-spinal axis:

23.4 Gy in 13 fractions of 1.8 Gy

Posterior fossa:

30.6 Gy in 17 fractions of 1.8 Gy

1 Gy b.d. (minimum interval between fractions 8 hours). 10 fractions per week

Craniospinal axis:

36 Gy in 36 fractions of 1 Gy

Posterior fossa:

24 Gy in 24 fractions of 1 Gy

Tumour Bed:

8 Gy in 8 fractions of 1 Gy

Standard Fractionation Regimen

Hyperfractionated Radiotherapy

DOZ François, MD

This is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma.

Patients eligible for the study will be those with non-metastatic medulloblastoma (by imaging and CSF cytology) at diagnosis. Patients randomised to the standard arm will receive conventionally fractionated (once a day) radiotherapy with a dose of 54 Gy to the posterior fossa and 23.4 Gy to the craniospinal axis. The experimental arm will be hyperfractionated (twice a day) radiotherapy (1 Gy b.d.) with a dose of 60 Gy to the posterior fossa with an additional 8 Gy to the tumour bed and 36 Gy to the craniospinal axis. Both groups will receive identical chemotherapy consisting of eight weekly doses of Vincristine given with radiotherapy and 8 courses of CCNU, cisplatin and vincristine following radiotherapy.

Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

To compare in a randomised trial the event free survival rate for children and adolescents with standard risk medulloblastoma treated with either hyperfractionated radiotherapy or reduced dose radiotherapy with conventional fractionation.

Will hyperfractionated radiotherapy lead to a different progression free (PFS) and overall survival (OS) compared to the standard arm radiotherapy?

Will hyperfractionated RT lead to a different pattern of local tumour control/pattern of relapse with particular respect to local relapse (tumour bed, posterior fossa outside the tumour bed) compared to the standard arm RT? The time to local progression should be the measure for the local tumour control.

To determine the toxicity of surgery.To investigate whether there are identifiable factors that correlate with toxicity.

To define the impact of any complications of surgery on commencement of adjuvant therapy and on EFS.

Institut Curie

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

This groups is treated with standard radiotherapy treatment: RT 2.0 Gy daily to final radiation dose 68.0 Gy or

Treated with Hyperfractionated radiotherapy (HFX-RT): Gy twice daily (10 fractions/week) with final dose 83.0 Gy

83.0 Gy in 68 fractions, 1.22 Gy per fraction, two daily fractions, five days per week to the primary tumour volume (GTVT_83.0). To the primary tumour with an added margin (PTVT_74.8) and to neck node metastases (PTVN_74.8) the prescribed dose will be 74.8 Gy in 68 fractions, 1.10 Gy per fraction twice daily. To elective neck nodes (PTV 54.4) the prescribed dose will be 54.4 Gy in 68 fractions, 0.80 Gy per fraction twice daily.

Hyperfractionated radiotherpy

68.0 Gy in 34 fractions, 2.00 Gy per fraction per day, five or six days per week to tumour volumes and 54.4 Gy in 34 fractions, 1.60 Gy per fraction to elective neck nodes.

Control group

Maria Gebre-Medhin, MD

Ingrid Müchler

Ann-Sofie Fransson, MD

Hedda Haugen, MD

Mattias Olin, MD

Björn Kullinger, MD

Jan Rzepecki, MD

Michael Gubanski, MD

Björn Zackrisson, MD

Zahra Taheri Kadkhoda, MD

Zuzana Lovasova, MD

Erik Lundin, MD

There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma (HNSCC) and to improve treatment results for patients with advanced disease. In this phase III study, HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy (RT) will be randomised between standard treatment (conventionally fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final RT dose 83.0 Gy.

In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune profiling, comparisons of global gene expression, gene aberrations and protein expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation and during patient follow-up. Patients with tumours with lower risk of recurrence, not eligible for randomisation in the study, can still participate in the translational parts of the study not investigating response to altered fractionation.

a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

ARTSCAN VI Protocol Version 1, 2023-07-03 ARTSCAN VI - a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

Local tumour control after treatment with conventionally fractionated (standard) RT compared with hyperfractionated radiotherapy (HFX-RT)

Lund University Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Cisplatin

Etoposide phosphate

Enzyme Inhibitors

Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).

Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/15 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).

Thoracic radiotherapy (45 Gy/30 fractions) for the Hyperfractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).

Hyperfractionated radiotherapy

Thoracic radiotherapy (45 Gy/15 fractions) for the Hypofractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).

Hypofractionated radiotherapy

Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.

Cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.

Ming Chen, MD, PhD

For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority trial.

A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC

A Multicenter, Prospective, Randomized Study Comparing Hypofractionated Radiotherapy With Hyperfractionated Radiotherapy Combined With Concurrent Chemotherapy and Omitting Clinical Target Volumes of the Primary Tumor in Limited-stage SCLC

PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.

OS, measured from the date of randomization to the date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma	NCT01351870	Medulloblastoma	Standard Fracti... Hyperfractionat...	4 Years - 22 Years	Institut Curie
a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients	NCT06248996	Head and Neck S...	Hyperfractionat... Control group	18 Years - 100 Years	Lund University Hospital
A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC	NCT04543890	Small Cell Lung...	Hyperfractionat... Hypofractionate... Etoposide Cisplatin	18 Years - 75 Years	Zhejiang Cancer Hospital
a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients	NCT06248996	Head and Neck S...	Hyperfractionat... Control group	18 Years - 100 Years	Lund University Hospital
A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC	NCT04543890	Small Cell Lung...	Hyperfractionat... Hypofractionate... Etoposide Cisplatin	18 Years - 75 Years	Zhejiang Cancer Hospital

Spots Global Cancer Trial Database for hyperfractionated radiotherapy