RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: NCT03599765 External Beam Radiation to Eliminate Nominal Metastatic Disease (EXTEND): A Randomized Phase II Basket Trial Assessing the Efficacy of Upfront Local Consolidative Therapy (LCT) for Oligometastatic Disease (2018-0349)

Status

Open

Description

The underlying hypothesis for this protocol is that rendering a metastatic solid tumor patient exhibiting a limited number of radiologically visible metastatic lesions to a state where there is no evidence of visible disease (NED) will result in an improvement of progression free survival (PFS). Although not tested as a primary outcome in this trial, we further hypothesize that rendering these patients NED improves overall survival, improves time to next line of systemic therapy, and does not lead to noticeable detriment in the patient’s quality of life.The primary goals of this study is to evaluate whether definitive local consolidative therapy (LCT) improves progression free survival (PFS) in patients with oligometastatic solid tumors of select histologies compared with patients who do not receive upfront LCT. Secondary objectives include determining whether: a)upfront LCT improves overall survival (OS), b) improves time to new lesion failure (TNLF), and c) to assess the safety of LCT and associated QOL of treated patients. Exploratory objectives include assessing tumor biopsy and peripheral blood for predictors of benefit and to assess the ability of radiation to activate the systemic immune system. For the purpose of this study metastatic disease will be defined as oligometastatic if ≤5 active metastatic lesions are present at enrollment (not including the primary site and regional lymph nodes).

Objective

The primary objective of this study is to assess PF with upfront LCT vs. no LCT among randomized patients with oligometastatic malignancies.

Treatment

Experimental Upfront LCT: Trial treatment will consist of local therapy to all sites of active disease including metastatic lesions and the primary/regional disease with definitive intent. Surgical options will include standard of care procedures that are considered definitive treatment options including but not limited to surgical resection, cryotherapy, and radiofrequency ablation (RFA). Experimental No Upfront LCT: Trial treatment will consist of systemic therapy as detailed in Section 4.4.2. Patients enrolled in this arm will have the option of treatment with definitive LCT to all sites of disease at the time of progression.

Conditions

Other

Phases

II

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Olson, Michael

Practice

Oligometastatic

Scope

National

Participating Institutions

Baptist MD Anderson Cancer Center

Eligibility

Inclusion: - No more than 4 prior lines of systemic therapy administered to treat metastatic disease. - Be > 18 years of age on the day of signing informed consent. - ECOG performance status 0-2. - Pathologically confirmed diagnosis of cancer as specified in sections 4.1.1.1 and 4.1.1.2. Exclusion: - Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy. - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. - In the event that a curative systemic option exists for metastatic disease from a given disease site. First-line metastatic patients (those patients who have had no prior lines of systemic therapy targeting their metastatic disease) are only eligible for enrollment if they have completed their curative systemic therapy per the judgement of the treating oncologist and have persistent disease.

Nct ID Number

NCT03599765

Secondary Trial ID Number

2018-0349/EXTEND

Keywords

Treatment

More Information

clinicaltrials.gov

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