Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study

Conditions

• Metastatic Colorectal Adenocarcinoma
• Stage IV Colorectal Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stereotactic Ablative Radiotherapy — PROCEDURE
  Undergo SABR
• Resection — PROCEDURE
  undergo surgical resection
• Microwave Ablation — PROCEDURE
  undergo microwave ablation
• Chemotherapy — DRUG
  Receive SOC chemotherapy
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo PET scan

Study Details

This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.

Key Dates

Start date

Oct 9, 2023

Status verified

Jun 2026

Primary completion

Jul 3, 2028

Completion

Aug 12, 2032

Study Design

Enrollment

364 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 (TAT, SOC chemotherapy
  Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo CT or MRI or PET/CT scans throughout the trial.
• Active Comparator: Arm 2 (SOC chemotherapy)
  Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death due to all causes, assessed up to 5 years ]

Central Contacts

• Eric D. Miller, MD, PhD
  614-685-4922
  [email protected]

Locations (184)

Find similar trials in Kingman, AZ

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