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NCT Number: NCT06310564

Low and Intermediate Risk OliGometastatic ColoREctal CancEr PatieNts Treated with Stereotactic ABlative Radiotherapy

This is an experimental study without drug or device, randomized, open-label, non-profit, sponsored by the IRCCS Sacro Cuore Don Calabria Hospital in Negrar, which will take place at the Department of Advanced Oncological Radiotherapy and 18 other Italian centers.

The reason for this research study is to evaluate whether stereotactic radiotherapy treatment (SABR), in addition to the systemic chemotherapy treatment foreseen by clinical practice for low-intermediate risk oligometastatic colorectal cancer, is able to:

* delay possible local recurrence and/or distant polymetastatic progression * improve disease-free survival * reduce side effects in the short and long term

thus inducing an improvement in the quality of life of patients suffering from this type of pathology.

Therefore, as part of this randomized study, before starting first or second line systemic therapy for his tumor, the patient will be randomized to one of the following treatment arms:

* Experimental arm: ablative stereotactic radiotherapy on all sites of oligometastatic disease (from 1 to 3 sites, performed at most within the second cycle of systemic therapy) * Control arm: no ablative stereotactic radiotherapy to sites of oligometastatic disease

The procedure that is intended to be tested in the experimental arm is a stereotactic radiotherapy treatment on oligometastases (up to a maximum of 3 sites), with ablative dosage (effective biological dose >100 Gy), performed before the start of systemic therapy of I or II line (at most within the second cycle of the same).

It is hoped that the addition of this type of radiotherapy will increase the potential clinical benefit of the treatment in the context of colorectal cancer.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, 37024, Italy

Location status: Recruiting

Location contact

Luca Nicosia, Doctor

CONTACT

[email protected]

+39(0)456014800

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Histologically confirmed CRC
  • Low and intermediate risk oligometastatic colorectal cancer with 1 to 3 metastases, candidate to I or II line systemic treatment (Low risk: 1 to 3 metastases and cumulative tumor volume smaller than 10 cm3; Intermediate risk: 1 to 3 metastases and cumulative tumor volume bigger than 10 cm3).
  • Controlled primary tumor regardless of primary surgery or primary systemic treatment
  • ECOG/WHO 0-2
  • Life expectancy > 6 months
  • Lesions ≤ 5 cm
  • Adequate organ function for the planned treatment according to local guidelines
  • For patients with liver metastases: no cirrhosis or hepatitis, and evidence of adequate hepatic function (Total bilirubin level < 1.5 x institutional ULN; ALT and AST levels < 3.0 x institutional ULN, GGT and alkaline phosphatase levels < 3.0 x institutional ULN; INR and APTT levels < 1.5 x institutional ULN, Albumin > 2.5 mg/dL)
  • For patients with liver metastases: unresectable liver metastases (assessed by a surgeon, preferably hepatobiliary) or refusal of liver surgery before study screening.
  • If childbearing potential, willing to use an effective form of contraception throughout the duration of the study
  • Signed informed consent and willingness to follow the trial procedures

Exclusion criteria

  • Age < 18 years
  • Brain metastases
  • Having more than 3 metastases
  • Malignant pleural effusion or ascites
  • Unable to undergo imaging by either CT scan or MRI
  • Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
  • Pregnancy or breast-feeding

Treatment and study plan

SABR

Radiation

A biological effective dose (BED) ≥125 Gy10 should be administered when constraints to the organs at risk (OARs) are respected [10]; if not possible, a BED schedule no lower than 100 Gy10 should be administered. In compliance with these instructions, treatment schedules, total dose and fractionation will be prescribed according to the clinical practice of each participating Center. The constraints for the organs at risk will be respected according to the available data.

In any case, biological effective dose (BED) ≥125 Gy10 should be administered when constraints to the organs at risk (OARs) are respected; if not possible, a BED schedule no lower than 100 Gy10 should be administered.

SABR will be administered before systemic treatment start, or before starting the second systemic treatment cycle at the latest.

Primary outcomes

  1. Progression-free survival (PFS).

    Time frame: 7 years

    PFS is defined as the time between randomization to the radiological evidence of disease progression.

    For patients with a PFS event, PFS will be calculated as the time interval from the date of randomization to the date of first objective evidence of disease progression or death from any cause, whichever occurs first.

    For patients without a PFS event, PFS will be censored at the date of the last radiographic assessment prior to the date of study end.

Secondary outcomes

  1. Time to the polymetastatic conversion (tPMC)

    Time frame: 7 years

    tPMC will be defined as the time between randomization to the date of radiological occurrence of >5 new metastases. For patients without a tPMC event, time to tPMC will be censored at the date of the last radiographic assessment prior to the study end date.

  2. Local control (LC): the time between randomization to the date of radiological development of local progression after SABR.

    Time frame: 7 years

    For patients without LC, time to LC will be censored at the date of the last radiographic assessment prior to the study end date.

  3. Overall survival (OS)

    Time frame: 7 years

    OS will be defined as the time between randomization to the date of death or last follow-up. For patients who are alive at the time of the study end date, OS time will be censored on the last date the patient is known to be alive or the study end date, whichever occurs first.

  4. Time to start of the next systemic treatment line (NEST)

    Time frame: 7 years

    For patients without a NEST, time to NEST will be censored at the date of the last patient visit before the study end date.

  5. Number of adverse events as assessed by CTCAE v4.0

    Time frame: 60 months

    Number of adverse events as assessed by CTCAE v4.0

  6. Number of acute side-effects

    Time frame: from enrollment until 6 months after the last dose of SABR

    Acute side-effects

  7. Number of Late side-effects

    Time frame: from the 6 months after the last dose of SABR until up to 3 years after inclusion in the trial

    Late side-effects

  8. questionnaire QLQ-C30

    Time frame: 60 months

    Quality of life (QoL): QoL will be evaluate with the questionnaire QLQ-C30

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Official study title

A Prospective, Randomized Clinical Trial of Low and Intermediate Risk OliGometastatic ColoREctal CancEr PatieNts Treated with Stereotactic ABlative Radiotherapy: GREEN LaIT-SABR Study

Acronym: GREENLaIT-SABR

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Mar 15, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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