CClinicalTrials.gg
WithdrawnNCT03532204OLIVERUpdated May 22, 2019

Oligometastases of the LIVer Treated With Chemotherapy With ou Without Extracranial Stereotactic Body Radiation Therapy in Patients With Colorectal Cancer

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 Withdrawn.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

Why this study was withdrawn
no participants enrolled
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Liver Metastases
  • Colorectal Cancer

Keywords

  • Oligometastatis
  • SBRT
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female with age ≥18 years and \<85 years;
  2. Patient with histologically proven colorectal cancer;
  3. Patient with a curative surgical treatment (R0) of the primary tumor performed;
  4. Oligometastatic disease defined as 1 to 3 liver-only metastases (measurable lesion as per RECIST 1.1);
  5. Patient unfit for surgery or with unresectable metastases;
  6. Maximal diameter of largest metastasis: 30 mm;
  7. Patient naïve of chemotherapy in the metastatic setting or after a first-line of chemotherapy for metastatic disease but not having progressed up to 1 year (i.e. slowly progressing disease);
  8. WHO status 0-1;
  9. Adequate liver function: bilirubin \<3 mg/dL, albumin >2.5 g/dL;
  10. Adequate hematological function: absolute neutrophil count (ANC) >1.5 x 10⁹/L; platelets >100 x 10⁹/L, hemoglobin (Hb) >9 g/dL;
  11. Normal PT (>70%) and PTT except if the patient uses anticoagulants;
  12. Liver enzymes \<3 times upper limit of normal;
  13. Renal function must be adequate for infusion of iv. contrast agent for CT-scan according to the local policy;
  14. Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of study and up to 3 months following completion of therapy;
  15. Patient who have received the information sheet, dated and signed the informed consent form;
  16. Affiliated to the social security system.

Exclusion criteria

Exclusion Criteria:

  1. Healthy liver volume\<700 mL
  2. Life expectancy \<3 months;
  3. Patient fit for metastasectomy or hepatectomy;
  4. Extrahepatic metastases;
  5. Cirrhosis with Child Pugh score B or C;
  6. More than one line of chemotherapy in the metastatic setting or rapidly progressing disease;
  7. Previous local treatment of liver metastases;
  8. Treatment with any other investigational agent against cancer;
  9. Malignancies other than mCRC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent;
  10. Pregnant woman or breast feeding mother;
  11. Patient deprived of liberty or placed under the authority of a tutor. Patient with 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. Patient unable to understand the purpose of the study (language, etc.).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Chemotherapy + SBRT

    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

  • Active comparator
    Chemotherapy

    Patients will receive chemotherapy as initially scheduled

    Drug: Chemotherapy

Interventions

  • RadiationSBRT

    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

  • DrugChemotherapy

    At investigator's discretion

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Overall survival

    Defined as the time from the date of randomization to the date of documented death of any cause

    Time frame: 3 years

  3. 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

  4. 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

  5. Quality of life EORTC QLQ C30

    Will be assessed using self-administered questionnaires EORTC QLQ C30

    Time frame: up to 24 weeks

  6. Quality of life EORTC QLQ CR29

    Will be assessed using self-administered questionnaire QLQ CR29

    Time frame: up to 24 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03532204
Lead sponsor
UNICANCER
Responsible party
Sponsor
First posted
May 22, 2018
Start date
Apr 15, 2019 (estimated)
Primary completion
Dec 15, 2021 (estimated)
Completion
Aug 15, 2023 (estimated)
Last update
May 22, 2019

Study contacts

Stéphanie SERVAGI, MD
principal investigator · INSTITUT JEAN GODINOT, REIMS
Gilles CREHANGE, MD
principal investigator · CENTRE GEORGES FRANCOIS LECLERC, DIJON

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion