COLLISION RELAPSE Trial

NCT05861505 | Recruiting Phase 3 DMC

• 1 other identifier: NL78220.029.21
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to upfront repeat local treatment in patients with at least one locally treatable recurrent CRLM in the absence of extrahepatic disease.

Conditions

Colorectal Cancer; Liver Metastases; Liver Metastasis Colon Cancer; Chemotherapy Effect; Surgery; Recurrence

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS) per patient

  Primary objective is to compare overall survival (OS) in both study arms, counting from the date of randomization to the date of death of the patient or to the last day of follow-up (censored).

  5 years

Secondary Outcomes (9)

• Distant progression-free survival (DPFS) per patient

  5 years

• Local tumor progression-free survival (LTPFS) per patient and per tumor treated

  5 years

• Systemic therapy related toxicity per patient following neoadjuvant systemic therapy

  5 years

• Procedural morbidity and mortality per patient following repeat local treatment

  5 years

• Length of hospital stay per patient following repeat local treatment

  5 years

Study Arms (2)

Upfront repeat local treatment

ACTIVE COMPARATOR

Other: Repeat local treatment

Neoadjuvant systemic therapy followed by repeat local treatment

EXPERIMENTAL

Drug: Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B); Other: Repeat local treatment

Interventions

Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B) DRUG

Standard first line systemic treatment: CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B CAPOX 4x (12 weeks) FOLFOX/FOLFIRI 6x (12 weeks) Maximum 4 cycles of CAPOX or 6 cycles of FOLFOX/FOLFIRI +/- bevacizumab regardless of the location of primary tumor or RAS/BRAF mutation

Neoadjuvant systemic therapy followed by repeat local treatment

Repeat local treatment OTHER

Choice of repeat local treatment is to the discretion of the local investigator, and may be selected on a per patient basis. The safety, feasibility and preferred type of surgical resection(s) is at the discretion of the liver surgeon (whether or not combined with thermal ablation). The safety, feasibility and preferred type of thermal ablation(s) is at the discretion of the interventional radiologist (whether or not combined with surgical resection).

Neoadjuvant systemic therapy followed by repeat local treatment; Upfront repeat local treatment

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• Good performance status (ECOG 0-2 // ASA 1-3)
• Histological documentation of primary colorectal tumor
• Local treatment performed for initial CRLM
• New recurrence ≤12 months
• ≥1 locally treatable CRLM (resectable\* and/or ablatable)
• Total number of new CRLM ≤5
• Chemo-naïve or history of response to CAPOX/FOLFOX/FOLRIRI
• Life expectancy of at least 12 weeks
• Adequate bone marrow, liver and renal function

You may not qualify if:

• Extrahepatic disease
• MSI/dMMR
• Radical local treatment unfeasible or unsafe (e.g. insufficient future liver volume)
• Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites)
• Uncontrolled infections (\> grade 2 NCI-CTC version 3.0)
• Pregnant or breast-feeding subjects
• Immuno- or chemotherapy ≤ 6 weeks prior to the randomization
• Severe allergy to contrast media not controlled with premedication
• Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
• ECOG = Eastern Cooperative Oncology Group, ASA = American Society of Anesthesiologists, MSI = Microsatellite instability, dMMR = deficient mismatch repair
• \* Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Related Publications (1)

• Dijkstra M, Kuiper BI, Schulz HH, van der Lei S, Puijk RS, Vos DJW, Timmer FEF, Scheffer HJ, Buffart TE, van den Tol MP, Lissenberg-Witte BI, Swijnenburg RJ, Versteeg KS, Meijerink MR; COLLISION Trial Group. Recurrent Colorectal Liver Metastases: Upfront Local Treatment versus Neoadjuvant Systemic Therapy Followed by Local Treatment (COLLISION RELAPSE): Study Protocol of a Phase III Prospective Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2024 Feb;47(2):253-262. doi: 10.1007/s00270-023-03602-y. Epub 2023 Nov 9.

  PMID: 37943351 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Recurrence

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

M Dijkstra

CONTACT

+31(0)204444444; interventieradiologie@vumc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 17, 2023
• Study Start: April 24, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

NL (1)