SABR-SCAN Trial for Pulmonary Oligometastases

NCT ID: NCT02414334

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate SABR

Immediate stereotactic ablative radiotherapy (standard arm)

Group Type: ACTIVE_COMPARATOR

Stereotactic Ablative Radiotherapy (SABR)

Intervention Type: RADIATION

Delayed SABR

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

Group Type: EXPERIMENTAL

Stereotactic Ablative Radiotherapy (SABR)

Intervention Type: RADIATION

Interventions

Stereotactic Ablative Radiotherapy (SABR)

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.
• Metastases outside target organs (e.g. liver metastases or other) are radically treated locally (resection, radiofrequency ablation (RFA), microwave ablation (MWA), stereotactic radiotherapy, or other). Earlier resected or ablated (SABR, RFA, MWA) metastases to lung, liver, or other organ form no exclusion criterion. Brain metastases should be completely resected or treated with stereotactic radiosurgery. Bone metastases should be resected or treated with high dose radiotherapy (equivalent of > 40 Gy) and be asymptomatic.
• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

RT2015-02

Identifier Type: -

Identifier Source: org_study_id