Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients in this arm will continue to receive standard treatment of TKI alone

Patients will receive local consolidate radiation therapy to all oligo-metastatic sites plus radiation therapy to primary disease in addition to TKI

Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI

Local Consolidative Radiation Therapy

Dr. Anil Tibdewal, MD

Dr. Jai Prakash Agarwal, MD

A Phase II randomized controlled trial of TKI Alone versus TKI and Local Consolidative Radiation Therapy in oncogene driver mutated oligo metastatic Non-small cell lung cancer patients.

Randomization Arms: Eligible patients will be randomized in 1:1 ratio to TKI alone or TKI + LCRT. This will be an intention to treat randomized study.

Arm 1: Continuation of TKI therapy alone Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to loc0-regional disease and 1-5 oligometastatic sites

Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC

A Phase II Randomized Controlled Trial of TKI Alone Versus TKI and Local Consolidative Radiation Therapy in Oncogene Driver Mutated Oligo Metastatic Non Small Cell Lung Cancer Patients

Protocol manuscript is published and the results will be published in International peer-reviewed journal

Progression Free Survival will be defined as the time from the date of randomization until the date of disease recurrence or progression is documented, or until death in the absence of recurrence, whichever is earlier.

Overall survival will be defined as the time from randomization until the date of death from any cause in the presence or absence of recurrence.

Local control will be defined as the lack of progressive disease at the treated sites (complete response, partial response and stable disease).

Quality of life will be assessed for each arm

Toxicity will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years

Tata Memorial Hospital

Principal investigator

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Antineoplastic Agents

Herbal and Botanical

Antibodies

Angiogenesis Inhibitors

Immunoglobulins

Cola

Local Consolidative Therapy (LCT) will be defined as surgical resection or stereotactic body radiotherapy (SBRT) or a combination of both strategies

Appropriate second-line systemic therapy, as defined in the NCCN guidelines will be used during study treatment (https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf). The choice of specific regimen will be left to the discretion of the treating oncologist but cannot include other experimental or investigational treatment. Sample appropriate systemic therapies include FOLFOX or FOLFIRI with a biologic agent such as an anti-angiogenic antibody or anti-EGFR antibody.

Local consolidative therapy

Joshua Meyer, MD

This is a Phase II randomized multisite trial to study the effect of a combination of local consolidative therapy with systemic therapy in subjects with oligometastatic colorectal cancer who have progressed on the first line of therapy.

This is a Phase II randomized multisite trial to study the effect of a combination of local consolidative therapy with systemic therapy in subjects with oligometastatic colorectal cancer who have progressed on the first line of therapy. The primary objective of this study is progression free survival which is defined as time from randomization until disease progression is documented. Response will be evaluated by scans every 3 months (+/- 7 days). Subjects will continue systemic therapy for 6 months and then at the investigator's discretion, disease progression or unacceptable toxicity. Subjects who are not evaluable for the primary endpoint will be replaced. A total of 105 subjects will be randomized in 2:1 ratio into two cohorts that will receive a combination of LCT along with the systemic therapy or systemic therapy alone.

Arm A: LCT + systemic therapy; 70 subjects will be accrued Arm B: Systemic therapy alone; 35 subjects will be accrued

Systemic therapy will be second line chemotherapy as per NCCN guidelines with the choice of drugs at the treating physician's discretion. Crossover to LCT will be allowed at progression for subjects randomized to Arm B.

The study will be opened at a total of 5 sites with a duration of 26 months of accrual and 10 additional months of follow-up, with a total of 36 months. The study will be conducted in 2 phases with an interim analysis conducted when 29 PFS events have been observed to assess futility/ feasibility of the study.

Subjects will have the option of undergoing tumor biopsy and blood sampling before beginning treatment. A correlative study is proposed using the genomic risk group stratification proposed by Pitroda et al.\[9\] Collected blood will be analyzed at the conclusion of the trial, with the expectation of comparing levels of circulating tumor DNA between baseline and 3-month time-points between subjects in Arms A and B. As this technology is rapidly evolving, we are not specifying the technology that will be used and will use the most effective assay at the time of trial completion.

A total of 105 subjects will be randomized in 2:1 ratio into two cohorts that will receive a combination of LCT along with the systemic therapy or systemic therapy alone.

Local Consolidative Therapy in Colorectal Cancer

RT-167: Local Consolidative Therapy in Colorectal Cancer

To assess the impact of local consolidative therapy (LCT) (surgical resection and/or radiotherapy) on the PFS of subjects with oligometastatic colorectal cancer undergoing second-line systemic therapy. PFS- defined as the duration of time from randomization to date of disease progression or death, whichever occurs first. Individuals who are alive and progression free at last follow-up will be considered censored at the time of last tumor assessment.

To assess the impact of local consolidative therapy (LCT) (surgical resection and/or radiotherapy) on the overall survival (OS) of subjects with oligometastatic colorectal cancer undergoing second-line systemic therapy. • OS - defined as the duration of time from randomization to date of death. Individuals who are alive at last follow-up will be considered censored at the time of last contact.

To assess patient reported outcomes (PROs) as measured by the EQ-5D-5L instrument. • PRO - defined as the score on the EQ-5D-5L questionnaire, this will be measured at baseline, and then 2 other times after treatment has begun

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC	NCT05277844	Oligometastatic... Non-small Cell ... Driver Mutation	Local Consolida... TKI	18 Years - 99 Years	Tata Memorial Hospital
Local Consolidative Therapy in Colorectal Cancer	NCT05062720	Colorectal Canc...	Local consolida...	18 Years -	Fox Chase Cancer Center
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC	NCT05277844	Oligometastatic... Non-small Cell ... Driver Mutation	Local Consolida... TKI	18 Years - 99 Years	Tata Memorial Hospital

Spots Global Cancer Trial Database for local consolidative therapy