Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy

NCT05808790 | Not Yet Recruiting DMC

• 1 other identifier: ABR 82437
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

Brief Summary

COPPER is an international, multicenter, parallel-arm, phase III randomized controlled trial comparing two local treatment strategies (SABR or metastasectomy) for patients with an indication for local treatment for limited (max. three) colorectal pulmonary metastases

Conditions

Lung Metastases; Colorectal Cancer Metastatic

Keywords

Colorectal pulmonary metastases; Pulmonary metastasectomy; Stereotactic radiotherapy; Randomized controlled trial; Colorectal cancer metastases

Outcome Measures

Primary Outcomes (1)

• Local recurrence-free survival

  Time from randomization to local recurrence or death from any cause

  From date of randomization through study completion, up to 10 years

Secondary Outcomes (10)

• Overall survival (OS)

  5 years

• Progression-free survival (PFS)

  5 years

• Local recurrence rate (LRR) per tumor

  5 years

• Quality of life (QoL) assessment - EuroQoL (EQ-5D-5L)

  5 years

• Quality of life assessment - Functional Assessment of Cancer Therapy: General (FACT-G)

  5 years

Study Arms (2)

Minimally invasive pulmonary metastasectomy

ACTIVE COMPARATOR

Minimally invasive parenchymal sparing pulmonary metastasectomy Surgical approach by means of video-assisted thoracic surgery (VATS), robot-assisted (RATS), or uniportal VATS

Procedure: Minimally invasive pulmonary metastasectomy

Stereotactic ablative radiotherapy

EXPERIMENTAL

Gross tumor volume = tumor visible on CT (+/- PET) No CTV margin will be added (Clinical target volume (CTV) = Gross target volume (GTV)) Planning Target Volume (PTV): GTV plus margins of 3-5mm (varying depending on site, motion, SABR delivery approach)

Radiation: Stereotactic ablative radiotherapy

Interventions

Minimally invasive pulmonary metastasectomy PROCEDURE

Surgical margin is equal to tumor size, if possible The goal is a parenchymal-sparing resection

Also known as: Lung metastasectomy

Minimally invasive pulmonary metastasectomy

Stereotactic ablative radiotherapy RADIATION

Depending on tumor location, 54 Gy in 3 fractions, 55 Gy in 5 fractions, 60 Gy in 8 fractions.

Also known as: SABR, Stereotactic body radiation therapy (SBRT)

Stereotactic ablative radiotherapy

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
• Eastern Cooperative Oncology Group (ECOG)-Performance status 0 - 2
• Willing to provide informed consent
• Patients with 1 to 3 lung metastases from colorectal cancer eligible for both a minimally invasive surgical resection and SABR, as assessed by the multidisciplinary tumor board (MDT)
• Radically treated primary colorectal cancer
• Patient is able and willing to complete the quality-of-life questionnaires
• Previous liver metastases are radically treated with curative intent
• Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.

You may not qualify if:

• Previous or present metastases outside liver or lungs
• Concurrent malignant cancer, or history of other malignant cancers within the past 5 years (excluding prespecified low-risk cancers)
• Hilar or mediastinal lymph node metastases
• Poor cardiopulmonary function test
• Inability to treat all colorectal metastases
• Surgical resection by means of a bilobectomy or pneumonectomy

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Dutch Cancer Society: collaborator

Study Sites (1)

Amsterdam University Medical Center (AUMC)

Amsterdam, 1081 HZ, Netherlands

Location

Related Publications (12)

• Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.

  PMID: 7799047 BACKGROUND

• Pastorino U, Buyse M, Friedel G, Ginsberg RJ, Girard P, Goldstraw P, Johnston M, McCormack P, Pass H, Putnam JB Jr; International Registry of Lung Metastases. Long-term results of lung metastasectomy: prognostic analyses based on 5206 cases. J Thorac Cardiovasc Surg. 1997 Jan;113(1):37-49. doi: 10.1016/s0022-5223(97)70397-0.

  PMID: 9011700 BACKGROUND

• Palma DA, Salama JK, Lo SS, Senan S, Treasure T, Govindan R, Weichselbaum R. The oligometastatic state - separating truth from wishful thinking. Nat Rev Clin Oncol. 2014 Sep;11(9):549-57. doi: 10.1038/nrclinonc.2014.96. Epub 2014 Jun 24.

  PMID: 24958182 BACKGROUND

• Ritter TA, Matuszak M, Chetty IJ, Mayo CS, Wu J, Iyengar P, Weldon M, Robinson C, Xiao Y, Timmerman RD. Application of Critical Volume-Dose Constraints for Stereotactic Body Radiation Therapy in NRG Radiation Therapy Trials. Int J Radiat Oncol Biol Phys. 2017 May 1;98(1):34-36. doi: 10.1016/j.ijrobp.2017.01.204. No abstract available.

  PMID: 28587050 BACKGROUND

• Devlin NJ, Krabbe PF. The development of new research methods for the valuation of EQ-5D-5L. Eur J Health Econ. 2013 Jul;14 Suppl 1(Suppl 1):S1-3. doi: 10.1007/s10198-013-0502-3. No abstract available.

  PMID: 23900659 BACKGROUND

• Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2.

  PMID: 32484754 BACKGROUND

• Treasure T, Farewell V, Macbeth F, Monson K, Williams NR, Brew-Graves C, Lees B, Grigg O, Fallowfield L; PulMiCC Trial Group. Pulmonary Metastasectomy versus Continued Active Monitoring in Colorectal Cancer (PulMiCC): a multicentre randomised clinical trial. Trials. 2019 Dec 12;20(1):718. doi: 10.1186/s13063-019-3837-y.

  PMID: 31831062 BACKGROUND

• Lodeweges JE, Klinkenberg TJ, Ubbels JF, Groen HJM, Langendijk JA, Widder J. Long-term Outcome of Surgery or Stereotactic Radiotherapy for Lung Oligometastases. J Thorac Oncol. 2017 Sep;12(9):1442-1445. doi: 10.1016/j.jtho.2017.05.015. Epub 2017 May 30.

  PMID: 28576747 BACKGROUND

• Nelson DB, Tayob N, Nguyen QN, Erasmus J, Mitchell KG, Hofstetter WL, Sepesi B, Antonoff MB, Mehran RJ. Local failure after stereotactic body radiation therapy or wedge resection for colorectal pulmonary metastases. J Thorac Cardiovasc Surg. 2019 Oct;158(4):1234-1241.e16. doi: 10.1016/j.jtcvs.2019.02.133. Epub 2019 May 11.

  PMID: 31395367 BACKGROUND

• van Dorp M, Gonzalez M, Daddi N, Batirel HF, Brunelli A, Schreurs WH. Metastasectomy for colorectal pulmonary metastases: a survey among members of the European Society of Thoracic Surgeons. Interdiscip Cardiovasc Thorac Surg. 2023 Feb 6;36(2):ivad002. doi: 10.1093/icvts/ivad002.

  PMID: 36847670 BACKGROUND

• Nicosia L, Franceschini D, Perrone-Congedi F, Casamassima F, Gerardi MA, Rigo M, Mazzola R, Perna M, Scotti V, Fodor A, Iurato A, Pasqualetti F, Gadducci G, Chiesa S, Niespolo RM, Bruni A, Alicino G, Frassinelli L, Borghetti P, Di Marzo A, Ravasio A, De Bari B, Sepulcri M, Aiello D, Mortellaro G, Sangalli C, Franceschini M, Montesi G, Aquilanti FM, Lunardi G, Valdagni R, Fazio I, Scarzello G, Corti L, Vavassori V, Maranzano E, Magrini SM, Arcangeli S, Gambacorta MA, Valentini V, Paiar F, Ramella S, Di Muzio NG, Livi L, Jereczek-Fossa BA, Osti MF, Scorsetti M, Alongi F. A multicenter LArge retrospectIve daTabase on the personalization of stereotactic ABlative radiotherapy use in lung metastases from colon-rectal cancer: The LaIT-SABR study. Radiother Oncol. 2022 Jan;166:92-99. doi: 10.1016/j.radonc.2021.10.023. Epub 2021 Nov 5.

  PMID: 34748855 BACKGROUND

• Franks KN, McParland L, Webster J, Baldwin DR, Sebag-Montefiore D, Evison M, Booton R, Faivre-Finn C, Naidu B, Ferguson J, Peedell C, Callister MEJ, Kennedy M, Hewison J, Bestall J, Gregory WM, Hall P, Collinson F, Olivier C, Naylor R, Bell S, Allen P, Sloss A, Snee M. SABRTooth: a randomised controlled feasibility study of stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I nonsmall cell lung cancer considered to be at higher risk of complications from surgical resection. Eur Respir J. 2020 Nov 12;56(5):2000118. doi: 10.1183/13993003.00118-2020. Print 2020 Nov.

  PMID: 32616595 BACKGROUND

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Martijn van Dorp, MD

  AUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martijn van Dorp, MD

CONTACT

+31 20 444 4444; m.vandorp@amsterdamumc.nl

Simone Gooijer, MD

CONTACT

+31 20 444 4782; sa.gooijer@nwz.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multicenter, parallel-arm, phase III randomized controlled trial Patients will be randomized in a 1:1 manner to SABR or minimally invasive metastasectomy for the local treatment of three or less colorectal pulmonary metastases

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 11, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Digital data and documentation will be preserved for 15 years.
• Access Criteria: Data request can be done by contacting the PI.

Locations

NL (1)