Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Head and Neck Neoplasms

Disease Progression

Neoplasms, Second Primary

Neoplastic Processes

Disease Attributes

Switch to subsequent systemic therapy line, best supportive care or continue current systemic line

Definitive SABR to oligoprogressive lesions + continue current systemic therapy

Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.

Standard arm

SABR to all oligoprogressive lesions + continuation of current systemic therapy

Experimental arm

Silvine Benth

Mom Phat

Houda Bahig, MD, PhD

Denis Soulières, MD

A registry-based randomized phase II trial. A total of 46 patients with metastatic head and neck cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer

Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial

PFS defined from randomization to disease progression at any site or death

OS defined as time from randomization to time of death from any cause.

Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and quality of life 5-level EQ-5D

Measured using the Common Terminology Criteria for Adverse Events

Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm

Defined as time from randomization to time of subsequent therapy line

Centre hospitalier de l'Université de Montréal (CHUM)

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

SABR

Standard of care

Diane Trudel

Houda Bahig, MD PhD

Bertrand Routy, MD PhD

A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer

Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial

Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)

Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Nervous System Diseases

Brain Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Central Nervous System Diseases

Hypofractionated SRT (stereotactic radiotherapy)

Historical single-dose SRS (stereotactic radiosurgery)

Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of "oligometastatic" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible.

Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature.

HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation.

Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment.

To investigators knowledge, SRS and HSRT have not been prospectively compared.

Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer	NCT04989725	Head and Neck C... Metastatic Canc... Oligoprogressiv...	Standard arm Experimental ar...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer	NCT04989725	Head and Neck C... Metastatic Canc... Oligoprogressiv...	Standard arm Experimental ar...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer	NCT04405401	Lung Cancer Met...	SABR Standard of car...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (310 Gy) to the Historical Single-dose Radiosurgery (120 to 25 Gy) With Medico-economic Evaluation.	NCT05102747	Brain Metastasi... Oligoprogressio...	Hypofractionate... Historical sing...	18 Years -	Centre Francois Baclesse

Spots Global Cancer Trial Database for oligoprogression