Metastatic Colorectal CancerPhase 2RSCAMPTONCT01220063
Radiosensitizing Chemotherapy withSBRT for the Treatment of Inoperable Liver and/or Lung Metastases of CRC
A Phase 2 study testing Radiation and Irinotecan in people with Metastatic Colorectal Cancer, run by Institut Cancerologie de l'Ouest at 6 sites in France.
Trial summary
The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4 fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation session). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Radiation and Irinotecan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 6 sitesFrance
- Study dates
- 19 Oct 2007to Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years
- Social Insurance
- Performance Index <2
- Life expectancy> 6 months
- adenocarcinoma colorectal (histologically proven)
- Metastases (inoperable or recurrent after surgery),
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- hepatic localization and / or lung (up to 3 if one organ metastasis or 3 in total if the two bodies are metastatic). The largest diameter of the metastasis will < ou = 6cm for the liver, < or = 6 cm for the lung. If multiple metastases, the sum of their maximum diameter is 6cm < ou = the liver, < ou = 6 cm for the lung.
- Lesion (s) measurable (s) and evaluable (s)
- CT less than 3 weeks
- Patients must have received at least one prior chemotherapy regimen containing 5FU
- Patients may have received one or more lines of chemotherapy including irinotecan.
- bilirubin <1.5 x ULN
- AST and ALT <5x ULN
- neutrophils> 1.5x109 / L, platelets> 100x109 / L, hemoglobin> 9 g / dL
- TP, TCA Normal (only for patients treated with a permanent implant)
- Informed consent signed.
Who cannot join
- contraindication to the administration of irinotecan.
- History of radiotherapy in the thoraco-abdominal-cons indicating further irradiation.
- History of other invasive cancer treated in a period of less than 5 years (basal cell carcinoma and non-invasive cervical excepted)
- Metastatic disease diffuse or more than three metastases in the liver and / or lung during the natural history of disease (excluding any patient is having a complete radiological response on several metastases although 1-3 residual after treatment ( s) medical (at)).
- Location (s) tumor (s) = CTV to less than 12 mm laterally or less than 15 mm in the cranio-caudal, stomach, small intestine, esophagus, trachea, bronchi of right and left pulmonary arteries and right and left.
- Pregnancy or breastfeeding.
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- Lack of means or refusal to use effective contraception for men or women of childbearing age.
- Any other concomitant experimental treatment.
- Any other concurrent anticancer therapy, immunotherapy or hormonal therapy.
- Monitoring impossible because of psychological, sociological or because of geographical distance.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital Saint André
Bordeaux, 33075
Centre Oscar Lambret
Lille, 59 000
Centre Léon Berard
Lyon, 69 000
Centre hospitalier Lyon Sud
Lyon, 69000
Hôpital la Source
Orléans, 45100
Centre René Gauducheau
Saint-Herblain, 44805
About this study
Official title: CLINICAL MULTICENTER STUDY OF PHASE II Hypofractionated Stereotactic Radiotherapy With Irinotecan IN THE TREATMENT OF LIVER METASTASIS AND / OR PULMONARY, Unoperated or Recurrent After Surgery of a Colorectal Cancer
The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4 fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation session).
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Radiation, Irinotecan
- Keywords
- RSHF, Irinotecan, Colorectal Cancer, metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Also called RSHF
10 Gy for 4 times (total 40 Gy)
IrinotecanDrug
Also called Campto
40 mg/m² : Day 1 and day 8
| Study group | Role | What they receive |
|---|---|---|
| Radiation + Irinotecan | Other | Irinotecan will be administered :
- 40 mg/m² in serum physiologique during 30 to 90 min at D1 and D8 of radiotherapy
Radiotherapy (RSHF) will be administered :
* at D1, D3, D8 and D10
* 48 Gy, 12 Gy by fractions twice a week Receives: Radiation: Radiation; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumor Response Rate of Irradiated Lesions
The primary objective is to increase the tumor response rate following stereotactic radiotherapy delivered at a total dose of 48 Gy in 4 fractions over 2 weeks, administered concomitantly with irinotecan at 40 mg/m² (on the 1st and 3rd irradiation sessions).
Tumor response of the irradiated site will be assessed according to RECIST criteria by an investigator review committee, based on thoracic or hepatic CT imaging.
Objective response is defined as the percentage of patients achieving either a complete response (CR) or a partial response (PR).
Measured: 48 months
Secondary outcomes (1)
Progression-Free Survival at 1 Year
Progression-free survival (PFS) is defined as the time from the start of treatment to the first occurrence of disease progression (local or distant) or death from any cause.
Progression will be assessed according to RECIST criteria based CT imaging.
The 1-year PFS rate corresponds to the percentage of patients alive without disease progression at 12 months after treatment initiation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study start19 Oct 2007
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RIO EMMANUEL, MD, Study director, INSTITUT DE CANCEROLOGIE DE L'OUEST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220063
- Sponsor's protocol ID
- 06/9-R
- Acronym
- RSCAMPTO
- Status last verified
- Jun 2026
- First submitted
- 11 Oct 2010
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL MULTICENTER STUDY OF PHASE II Hypofractionated Stereotactic Radiotherapy With Irinotecan IN THE TREATMENT OF LIVER METASTASIS AND / OR PULMONARY, Unoperated or Recurrent After Surgery of a Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01220063
- Acronym / sponsor ID
- RSCAMPTO / 06/9-R
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- RSHF, Irinotecan, Colorectal Cancer, metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 19 Oct 2007 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 30 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4 fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation session).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation + Irinotecan | Other | Radiation: Radiation, Drug: IrinotecanIrinotecan will be administered : - 40 mg/m² in serum physiologique during 30 to 90 min at D1 and D8 of radiotherapy Radiotherapy (RSHF) will be administered : * at D1, D3, D8 and D10 * 48 Gy, 12 Gy by fractions twice a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age > or = 18 years
- Social Insurance
- Performance Index <2
- Life expectancy> 6 months
- adenocarcinoma colorectal (histologically proven)
Key exclusion criteria (10 listed)
- contraindication to the administration of irinotecan.
- History of radiotherapy in the thoraco-abdominal-cons indicating further irradiation.
- History of other invasive cancer treated in a period of less than 5 years (basal cell carcinoma and non-invasive cervical excepted)
- Metastatic disease diffuse or more than three metastases in the liver and / or lung during the natural history of disease (excluding any patient is having a complete radiological response on several metastases although 1-3 residual after treatment ( s) medical (at)).
- Location (s) tumor (s) = CTV to less than 12 mm laterally or less than 15 mm in the cranio-caudal, stomach, small intestine, esophagus, trachea, bronchi of right and left pulmonary arteries and right and left.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationAlso: RSHF10 Gy for 4 times (total 40 Gy) | Radiation | Radiation + Irinotecan |
| IrinotecanAlso: Campto40 mg/m² : Day 1 and day 8 | Drug | Radiation + Irinotecan |
Primary outcome
Objective Tumor Response Rate of Irradiated Lesions
Time frame: 48 months
The primary objective is to increase the tumor response rate following stereotactic radiotherapy delivered at a total dose of 48 Gy in 4 fractions over 2 weeks, administered concomitantly with irinotecan at 40 mg/m² (on the 1st and 3rd irradiation sessions). Tumor response of the irradiated site will be assessed according to RECIST criteria by an investigator review committee, based on thoracic or hepatic CT imaging. Objective response is defined as the percentage of patients achieving either a complete response (CR) or a partial response (PR).
1 secondary outcome
Progression-Free Survival at 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RIO EMMANUEL, MD study director
INSTITUT DE CANCEROLOGIE DE L'OUEST
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation and Irinotecan in people with Metastatic Colorectal Cancer, run by Institut Cancerologie de l'Ouest at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Tumor Response Rate of Irradiated Lesions (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.