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)

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

45 Gy in 25 fractions of 1.8 Gy per fraction over 5 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)

36 Gy in 20 fractions of 1.8 Gy per fraction over 4 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)

Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT , CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.

Standard Arm

Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT,CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.

Experimental Arm

Jayant Sastri Goda, M.D

Sidharth Laskar, M.D

Jayant Goda, M.D.

The purpose of this study is to compare standard dose radiation of 45 Gray(Gy) in 25 fractions in Non Hodgkin's Lymphoma- Diffuse Large B cell Lymphoma (NHL-DLBCL) to that of 36 Gy in 20 fractions.

The role of radiation in NHL-DLBCL has been addressed in large cooperative trials showing improvement in overall survival and progression free survival with combined modality treatment. The doses of radiation used in these trials are heterogeneous ranging from 30-55 Gray(Gy). There is uncertainty about the optimal dose of radiation needed in aggressive lymphomas. A dose response phenomenon is known in Non- Hodgkin's Lymphoma. Late effects of higher dose radiation in the form of higher risk of stroke, myocardial infarction, thyroid abnormalities and secondary breast cancer are being increasingly identified. Hence it is essential to optimize the dose of radiotherapy for lower toxicity without compromising on efficacy.

Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.

Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma (DOBL) - A Randomised Phase III Non- Inferiority Trial.

From the time of randomization till relapse or progression or death due to any cause or death due to disease.

Assessment by physiological parameter

From the time of randomization till the disease is controlled at the site of radiation.

Assessment by physiological parameter.

From the time of randomization to death due to any cause /death due to disease. assessment by physiological parameter

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)
Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.	NCT02964858	NonHodgkin Lymp...	Standard Arm Experimental Ar...	18 Years - 65 Years	Tata Memorial Hospital
Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.	NCT02964858	NonHodgkin Lymp...	Standard Arm Experimental Ar...	18 Years - 65 Years	Tata Memorial Hospital

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