An interventional study of SBRT and Chemotherapy in Liver Metastases and Colorectal Cancer, sponsored by UNICANCER. Withdrawn. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-05-22.
Sponsored by UNICANCER · Not applicable, Interventional, and Treatment
The role of radiotherapy in metastatic cancer has historically been limited to palliation while metastasectomy or radiofrequency has emerged as playing a major role in disease control. Although resection is the standard of care for liver metastasis, 80-90% of patients are not resectable at diagnosis in particular because of the presence of oligometastases. Factors that favour a truly oligometastatic state include a long latent interval between the treatment of the primary tumor and the appearance of metastases.
Oligometastatic cancer is a very heterogeneous disease with respect to several factors including the location of the primary tumor. With the advent of extracranial stereotactic body radiation therapy (SBRT), higher biological equivalent doses can be safely delivered in 3 to 5 fractions, thus potentially ablating all the tissue in the treated area while protecting more efficiently the hosting organ and healthy tissues surrounding the tumors.
In patients with liver oligometastases, in-field local control rates at 2 years range from 70% to 90% with less than 5% severe grade 3 or higher toxicity rates. Retrospective studies indicate that roughly 20% of the patients remain disease-free 2 to 4 years after SBRT.
For patients treated with SBRT some authors found that half of the patients had either no metastatic progression or very little progression in terms of number and site of metastases. The patterns of failure after SBRT for oligometastases in one organ showed that 73% of patients eventually developed new metastases with higher than 80% occurring as new metastases in the same index organ. These findings support the idea of an oligometastatic state in which aggressive local therapy could improve progression-free survival (PFS).
With this phase III study, we sought to evaluate the impact of SBRT on PFS at 2 years in patients with synchronous or metachronous liver-only oligometastases from colorectal cancers patients after a first line chemotherapy for metastatic disease but not having progressed during first line chemotherapy and up to 1 year
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Exclusion Criteria:
Patients will received 2 courses of chemotherapy before SBRT if no hepatic or extra-hepatic progression identified. All liver metastases will be irradiated. 4 doses prescription are allowed (according to the center, and the technique uded and the dosimetric constraints): 3x15 Gy, 4 x 15 Gy, 5 x10 Gy or 5 x 8 Gy. The remaining courses of chemotherapy 2 to 3 weeks after completion of SBRT will be administered
Radiation: SBRT · Drug: Chemotherapy
Patients will receive chemotherapy as initially scheduled
Drug: Chemotherapy
Patients will received 2 courses of chemotherapy before SBRT if no hepatic or extra-hepatic progression identified. All liver metastases will be irradiated. 4 doses prescription are allowed (according to the center, and the technique uded and the dosimetric constraints): 3x15 Gy, 4 x 15 Gy, 5 x10 Gy or 5 x 8 Gy. The remaining courses of chemotherapy 2 to 3 weeks after completion of SBRT will be administered
At investigator's discretion
Progression Free Survival
To evaluate the impact of SBRT on Progression-Free Survival (PFS) at 1 year according to RECIST 1.1
Time frame: 1 year
Local Control rate
Defined as the time from the date of randomization to the date of a documented loco-regional event
Time frame: 1 and 3 years
Overall survival
Defined as the time from the date of randomization to the date of documented death of any cause
Time frame: 3 years
Cancer specific survival
Defined as the time from the date of randomization to the date of documented death from cancer or complication from treatment
Time frame: 3 years
CTCAE Toxicity Assessment
Acute/ late toxicity will be assessed according to the flowchart and performed based on CTCAE V4
Time frame: up to 24 weeks
Quality of life EORTC QLQ C30
Will be assessed using self-administered questionnaires EORTC QLQ C30
Time frame: up to 24 weeks
Quality of life EORTC QLQ CR29
Will be assessed using self-administered questionnaire QLQ CR29
Time frame: up to 24 weeks
No study locations are listed for this record.
This study is withdrawn, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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