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RecruitingLast updated: 11 June 2024

RESOLUTE: This study is assessing the benefit of using a type of local ablative therapy (which could include surgery or radiation therapy) on top of standard of care treatment for people with colorectal cancerRandomised Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

Clinical summary

Summary

Eligible participants will be randomly allocated to either the local ablative therapy (LAT) arm, or the control arm. In the LAT arm, participants will receive metastasis-directed LAT such as radiation therapy or thermal ablation following initial standard first-line systemic treatment. In the control arm, participants will receive continued first-line systemic treatment alone. Those receiving LAT will return to systemic treatment 16 weeks post-randomisation.

Conditions

This trial is treating patients with metastatic colorectal cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

Not applicable

Trial Acronym

RESOLUTE

More information

Trial Identifiers

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Trial sponsor

Cancer Council Victoria

Scientific Title

Randomised Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

Eligibility

Inclusion

-Metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery.
-Primary tumour must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry
-Imaging demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of standard first-line systemic treatment.
-3 to 10 metastatic lesions detected on CT +/- FDG-PET scan prior to first line systemic treatment AND on screening FDG-PET and CT scans:
o maximum of 3 lesions per organ except for the liver.
o maximum of 3 involved organs including a lymph node station.
o only one lymph node station involvement is allowed.
-All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.

Exclusion

-Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen’s disease or prostate cancer with a Gleason score =6.
-Presence of brain, peritoneal, omental or ovarian metastases
-Malignant pleural effusion or ascites.

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

This trial is operating as a teletrial at one or more locations. Learn more about teletrials.

Recruiting hospitals

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On hold hospitals

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Victorian Cancer Registry Victorian Government

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RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.