SABR-SCAN Trial for Pulmonary Oligometastases

NCT02414334 | Completed

• 1 other identifier: RT2015-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: SABR (Stereotactic ablative radiotherapy) is one of the standard treatment options besides surgical resection for limited lung metastases (oligometastases) from colorectal cancer. High efficacy in terms of local control of metastatic lesions treated has been shown. Nevertheless, the precise effect of SABR upon progression-free- and overall survival in these patients is unknown. To further evaluate and develop local treatment options in metastatic disease, more information is necessary regarding the impact upon - and the pattern of - disease progression of local treatment options such as SABR. Objective: To determine the effect upon progression free survival and upon tumorload relative to baseline, both at one year after randomisation of immediate SABR versus delayed SABR (a scan-and-personalise policy). Secondarily, patterns of progression, patient-reported symptoms and quality of life will be monitored.

Conditions

Oligometastases

Keywords

Oligometastases; Stereotactic ablative radiotherapy (SABR); Metastatic tumours

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  12 months after randomisation

Secondary Outcomes (5)

• Relative change of tumourload expressed as volume of all tumour at one year divided by volume of all tumour at time of randomisation;

  12 months after randomisation

• Time to failure of local strategy (TFLS): failure = death or progressive disease NOT amenable to local treatment

  when it occurs

• Progression of target lesions as measured by CT

  12 months after randomisation

• Health-related quality of life profile

  Baseline; 3 months after randomisation and at 6, 9, 12, 15, 18, 21 and 24 months

• Progression of lesions other than target lesions as measured by CT

  12 months after randomisation

Study Arms (2)

Immediate SABR

ACTIVE COMPARATOR

Immediate stereotactic ablative radiotherapy (standard arm)

Radiation: Stereotactic Ablative Radiotherapy (SABR)

Delayed SABR

EXPERIMENTAL

Delayed stereotactic ablative radiotherapy (delayed= treatment six months after randomisation or at disease progression) (experimental arm)

Radiation: Stereotactic Ablative Radiotherapy (SABR)

Interventions

Stereotactic Ablative Radiotherapy (SABR) RADIATION

Delayed SABR; Immediate SABR

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
• WHO-Performance status (WHO-PS) 0 - 1
• Patients with 1 to 3 lung metastases between 8 mm and 3 cm each, from colorectal cancer. Resection has been considered at a multidisciplinary conference but was not recommended or has been refused by the patient.
• Possibility to define target lesions that fulfil the following criteria:
• No lesion larger than 3 cm;
• Not more than 3 metastases ≥ 8 mm in total (lesions smaller than 8 mm in diameter are NOT counted and will NOT be irradiated);
• No prior radiotherapy (SABR or other) within about 2 cm from target lesions (i.e., the distance between prior planning-target-volume (PTV) to actual intended PTV is more than 2 cm AND dose distribution of former radiation permits SABR).
• Primary tumour has been completely removed surgically.
• Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.
• Proficiency in the Dutch language so that quality-of-life questionnaires can be completed in Dutch and absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
• Before patient randomisation, informed consent must be given according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) of the European Union (EU) in accordance with good clinical practice (GCP), and national/local regulations.

You may not qualify if:

• Any clinical symptoms possibly or certainly caused by index lungmetastases
• Physical inability to undergo stereotactic radiotherapy (e.g., serious shoulder stiffness)
• Any uncontrolled malignancy other than index colorectal cancer
• Other malignancy within recent two years, even if completely under control (under control = no evidence of disease)

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 10, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

NL (1)