Local Consolidative Therapy in Colorectal Cancer

NCT05062720 | Withdrawn Phase 2 DMC

• 2 other identifiers: 20-1010RT-167
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer Metastatic

Keywords

oligometastatic; colorectal

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  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.

  6 months

Secondary Outcomes (2)

• Overall suvival (OS)

  6 months

• Patient reported outcomes (PROs)

  6 months

Study Arms (2)

Local consolidative therapy (LCT) + systemic therapy

EXPERIMENTAL

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

Radiation: Local consolidative therapy

Systemic therapy alone

ACTIVE COMPARATOR

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.

Radiation: Local consolidative therapy

Interventions

Local consolidative therapy RADIATION

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

Local consolidative therapy (LCT) + systemic therapy; Systemic therapy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histologically or cytologically confirmed metastatic colorectal cancer with 1-3 active metastatic lesions irrespective of location. Previously locally treated (e.g. radiation or interventional radiology-based ablated) metastases that have had a 6-month progression free interval per imaging exams, do not count toward the 1-3 active metastases. Adjacent lymph nodes in the same region constitute one active lesion.
• Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1 as described in detail in section 12.0.
• All sites of metastatic disease must be amenable to either surgical resection or stereotactic body radiotherapy (SBRT).
• The primary lesion may be either intact or previously resected, but if intact must be resected as part of LCT (primary does not count as one of 1-3 sites of metastatic disease).
• Subjects must have received at least one prior line of systemic therapy with a fluoropyrimidine-based regimen for metastatic disease and be candidates for further systemic chemotherapy. Front-line therapy could have been discontinued for disease progression, unacceptable toxicity, or drug holiday, provided that the therapy was discontinued less than six months from study enrollment.
• Age \> 18 years.
• ECOG performance status 0 or 1
• Subjects must have normal organ and marrow function as defined below
• Absolute neutrophil count \> 1,500/mcL
• Platelets \> 100,000/mcL
• Total bilirubin \< 2 mg/dL
• AST/ALT (SGOT/SGPT) \< 5X ULN
• Creatinine \< 1.5X ULN OR
• Creatinine clearance \< 50 ml/min/1.73 m2 for subjects with creatinine levels above institutional normal
• Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document.

You may not qualify if:

• Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous oxaliplatin exposure, alopecia and fatigue.
• \>Grade 2 sensory neuropathy
• Subjects must not be receiving any other investigational agents.
• Subjects must not have known central nervous system (CNS) metastases and/or carcinomatous meningitis, either untreated or treated.
• Subjects must not be unfit to receive combination therapy (\>/=2 drugs that could include one biologic agent) as determined by the treating physician.
• Subjects must be able to undergo surgical resection and/or SBRT.
• Subjects must not have 4 or more active metastatic sites.
• Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any condition or significant co-morbidity that prevents safe surgery or delivery of SBRT
• Subjects must not be pregnant or breast feeding. Refer to section 4.4 for further detail.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Study Officials

• Joshua Meyer, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: July 29, 2021
• Primary Completion: December 31, 2023
• Study Completion: October 31, 2025
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)