Neoplasms

All Conditions

Head and Neck Neoplasms

NID2Gy = 50 Gy Swallowing apparatus: standard dose

NID2Gy = 40 Gy Swallowing apparatus: Dmax ≤ 60 Gy at 1 cm Dmax ≤ 50 Gy at 1.5 cm from the GTV or PSTB edge

dose de escalation

standard dose

A randomized clinical trial was initiated to investigate whether a reduction of the dose to the elective nodal sites and the swallowing apparatus delivered by IMRT would result in a reduction of acute and late side effects without compromising tumor control.

1. Study hypothesis

   Dose de-escalation in the elective nodal sites and off-target regions of the swallowing apparatus delivered by IMRT does reduce overall rate of late dysphagia and neck fibrosis comparing to the standard dose to the elective nodal sites.
2. Primary endpoint

   To estimate the difference in overall rate of late dysphagia and neck fibrosis 1 year after the end of radiotherapy in patients receiving dose de-escalation to the elective nodal sites and off-target regions of the swallowing apparatus applying IMRT.
3. Secondary endpoints

Local, regional and distant control Recurrence and site of recurrence Overall, disease-free and disease-specific survival Acute toxicity Quality of life

Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer

Dose De-escalation to the Elective Nodal Sites, the Swallowing Apparatus and Neck Soft Tissues for Head and Neck Cancer: Multi-centre, Randomized Phase III Trial Using Image-guided Intensity-modulated Radiotherapy (IG-IMRT)

University Hospital, Ghent

Universitaire Ziekenhuizen KU Leuven

Professor

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Oropharyngeal Neoplasms

Laryngeal Diseases

Laryngeal Neoplasms

Hypopharyngeal Neoplasms

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Respiratory Tract Neoplasms

Laryngeal Cancer

Hypopharyngeal Cancer

Patients receive a radiation dose of 66Gy in 30 fractions to the planning target volume 1 (PTV1) and 54 Gy in 30 fractions to the PTV2 concurrent with platinum chemotherapy weekly

Patients receive a radiation dose of 73.5 Gy in 30 fractions to the boost target volume (BTV), 63Gy in 30 fractions to PTV1 and 54 Gy in 30 fractions to PTV2 concurrent with platinum chemotherapy weekly

Boost Target Volume (BTV): The PET CT GTV (thresholding at 40% of SUV max) with a 3mm margin will form the BTV.

CTV1: A 3mm area around the BTV avid primary or 2mm area around the node will form the CTV1.

CTV 2: This (CTV 2) includes the area around the primary or nodal levels at risk of harbouring microscopic primary or microscopic nodal metastatic disease and not already included in CTV1.

Planning Target Volume: PTV - A margin of 5mm will be added to each of the CTV to obtain the PTV.

BTV receives 73.5Gy in 30 fractions. PTV 1 receives 63Gy in 30 fractions. PTV 2 receives 54 Gy in 30 fractions.

All patients receive concurrent platinum chemotherapy.

Escalated Dose

CTV 1 includes 6mm isotropic margin around the entire PET-CT avid (thresholding at 40% of SUV max) larynx/ hypopharynx /oropharynx and 5mm isotropic margin around nodes.

CTV 2: This (CTV 2) includes the area around the primary or nodal levels at risk of harbouring microscopic primary or microscopic nodal involvement, or at risk nodal areas, and not already included in CTV1.

Planning Target Volume: PTV - A margin of 5mm will be added to each of the CTV to obtain the PTV.

PTV 1 receives 66Gy in 30 fractions. PTV 2 receives 54 Gy in 30 fractions.

All patients receive concurrent platinum chemotherapy.

Standard Dose

Sanjoy Chatterjee, FRCP, FRCR

The primary objective of the study is to establish the safety of using a moderate escalation of radiotherapy dose in advanced/poor prognosis OPC and LH cancers receiving curative radiotherapy.

The study will also explore the efficacy (improvement in complete response rates at 2 years) of dose escalation in intermediate and high risk OPC and LH cancers patients.

Patients with locally advanced Laryngeal, Hypopharyngeal (LH) or oropharyngeal (OPC) head and neck squamous cell carcinomas have 5 year survival ranging between 25-45%. 60% of all LH cancers occur in the developing world and its incidence in India ranges from 1.8-8.8 per 1,00,000 population .

Local control outcomes of OPC patients with stage III and IV OPC has been modest with reported loco-regional control rates of 50-60% at 5 years. For patients with locally advanced LH a 60-70% 2 year survival is seen and loco-regional control rates of 70% have been reported . Majority of locally advanced OPC and LH cancers are treated with a combination of chemotherapy and radiotherapy (CRT) with organ and function preserving approach.

Identifying the area of tumour involvement in the OPC and LH could be challenging on CECT scans, requiring metabolic imaging with PET-CT for more precise definition of radiation target.

Improvements in radiation treatment delivery techniques have enabled clinicians to explore the possibility of improving tumour control probability (TCP) and reduce normal tissue complication probability . This allows us to explore the role of escalating dose in the above group of patients to assess the safety and efficacy of the regime.

Tumours treated in the standard dose arm will receive radiotherapy @ 220 cGy per fraction for 30 fractions whilst those in the escalated dose arm will receive @ 245 cGy per fraction for 30 fractions using IMRT techniques. Patients in both arms will receive weekly platinum based chemotherapy concurrent with radiotherapy.

Dose Escalation Versus Standard in Laryngopharyngeal Cancers

Intensifying Radiation Treatment in Advanced/ Poor Prognosis Laryngeal, Hypopharyngeal (LH) and Oropharyngeal Cancers (OPC) Using PET -CT Based Dose Escalation Strategies ( INTELHOPE)

Once appropriate authorities approach and once clearance of local authorities is received, data could be shared

In addition: Interim assessment for early stoppage is if 35% or more patients in the intervention arm has Grade 4 mucositis or dysphagia

Tata Medical Center

Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost

Dose escalation

Standard dose to good responders to achieve dose equivalent of 70 Gy.

Standard dose

Roa El-Tagy

May Ashour

Tarek Shouman

This is a prospective trial evaluating dose escalation using an SBRT boost to poor- responding tumors by interim functional imaging (PET/CT and fMRI) to improve the local control of HNCSCC.

Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy ￼

Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging

National Cancer Institute, Egypt

assistant lecturer

Digestive System Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Pancreatic Neoplasms

Vitamin D Deficiency

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Gastrointestinal Agents

Vitamins

Vitamin D

Cholecalciferol

Pancrelipase

Pancreatin

Vitamin D3

Calciferol

Intervention with high dose oral vitamin D3 supplementation.

1 drop equals 400 I.U. This group will get 180.000 I.U. on day 1, and then 4000 I.U. per day for 60 days.

Intervention with standard dose oral vitamin D3 supplementation.

1 drop equals 400 I.U. This group will get 800 I.U. per day for 60 days.

Patients will receive a high dose - 180.000 I.U. (1 drop equals 400 I.U.) of Vitamin D3 orally on day 1, and then 4000 I.U. for 60 days

High-dose

Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days

Peter Kornprat, Prof. Dr.

Different studies have shown that a deficiency in vitamin D (≤20ng/mL) results in higher rates in morbidity and mortality rates in cancer patients. Clinical studies investigated and demonstrated altered vitamin d tissue in pancreatic cancer. But there is no prospective study evaluating the beneficiary effects of oral supplementation of vitamin d in altered vitamin d tissue from pancreatic cancer. We want to examine the effect of a high dose vitamin D3 therapy vs. a standard base dose vitamin D3 therapy in pancreas cancer patients with a vitamin D deficiency. In case of benefit in our results we could implement vitamin D3 as a supportive standard therapy in pancreatic cancer patients.

High-dose Vitamin D3 in Pancreas Cancer

Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study

Number of patients who die in the specified timeframe

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer	NCT01812486	Head and Neck C...	dose de escalat... standard dose	18 Years -	Universitaire Ziekenhuizen KU Leuven
Dose Escalation Versus Standard in Laryngopharyngeal Cancers	NCT02757222	Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl...	Escalated Dose Standard Dose	18 Years -	Tata Medical Center
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy	NCT04933357	Head and Neck C...	Dose escalation Standard dose	18 Years -	National Cancer Institute, Egypt
High-dose Vitamin D3 in Pancreas Cancer	NCT03472833	Pancreas Cancer Vitamin D Defic... Quality of Life	High-dose Standard dose	18 Years - 99 Years	Medical University of Graz
Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer	NCT01812486	Head and Neck C...	dose de escalat... standard dose	18 Years -	Universitaire Ziekenhuizen KU Leuven
Dose Escalation Versus Standard in Laryngopharyngeal Cancers	NCT02757222	Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl...	Escalated Dose Standard Dose	18 Years -	Tata Medical Center

Spots Global Cancer Trial Database for standard dose