Rectal CancerDESIRNCT03634202
Study of Radiation Therapy in Combination With Xeloda, for Initially Metastatic, Low and Middle Rectal Cancer
A study testing IMRT + oral chemotherapy in people with Rectal Cancer and Metastasis, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
In initially metastatic rectal carcinoma, a neo-adjuvant multi-drug chemotherapy is usually performed, followed by a pelvic chemoradiation. The surgical indications on both metastases and the pelvic site are then discussed: in the case where a complete (or near-complete) response (CR) of the rectal tumor is observed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Metastasis, Radiotherapy
- What is being tested?
- IMRT + oral chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2015to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Metastatic distal rectal carcinoma (low and middle);
- age >18 years
- Estimated life expectancy greater than 3 months
- PS: ECOG<2
- Normal hematologic, renal and hepatic functions
- Normal or only partially decreased DPD activity
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- Effective contraception in women and men of childbearing age
- Social insurance.
- Signed informed consent
Who cannot join
- No previous treatment with pelvic radiotherapy or chemotherapy
- Disorder precluding understanding of trial information or informed consent
- No severe or uncontrolled disease (infection, VIH, HBs, diabetes mellitus)
- No peripheral neuropathy > grade 2
- No inflammatory disease or fructosemia
- Diarrhea of grade > 2
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- Pregnancy, breastfeeding women
- Patients already included in another therapeutic within a period of 30 days
- Other malignancy treated within the last 5 years (except non-melanoma skin cancer)
- Bilateral total hip prosthesis
- Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase-1 Study of Escalated-dose Pelvic Radiation Therapy Using Intensity-Modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB), in Combination With Xeloda, for Initially Metastatic, Low and Middle Rectal Cancer
In initially metastatic rectal carcinoma, a neo-adjuvant multi-drug chemotherapy is usually performed, followed by a pelvic chemoradiation. The surgical indications on both metastases and the pelvic site are then discussed: in the case where a complete (or near-complete) response (CR) of the rectal tumor is observed (10 to 40%), the local surgery may be omitted or poned ("wait-and-see") in a sphincter-sparing strategy, in order to minimize or avoid the surgical morbidity, to focus on metastatic disease by the continuation of chemotherapy, and to preserve a better quality of life. After 8 weeks of induction chemotherapy (mFolfox6 regimen, 4 cycles), the aim of our study is to optimize the chemoradiation step on the distal rectal tumor, thanks to Intensity-Modulated Radiotherapy (IMRT) with simultaneous integrated boost (SIB) (Phase-1 part of the study), concomitantly with oral capecitabine. According to a Fibonacci dose-escalation scheme, 3 radiation dose-levels are defined, up to the definition of the maximal tolerated dose (MTD), requiring the inclusion of a maximum of 20 patients. Further patients will be included at the recommended dose for phase-2 (RDP2) in a two-step phase-2 study, considering simultaneously as principal objective at 12 months, both the efficacy (local CR rate in the range of 10 to 25%) and the tolerance (pelvic radiation disease: grade 3-4 toxicities in the range of 30 to 10%). Overall 65 patients will be included in the phase-2 study at the RDP2 dose.
Read the detailed description
The study population has metastatic rectal cancer. After obtaining informed consent and if they fulfil all of the criteria for inclusion, patients will be included.
After 8 weeks of induction chemotherapy with FOLFOX, patients perform an imaging assessment.
Then they are treated by radiotherapy with an oral Xeloda At the end of irradiation, patients realize on other Imaging assessment. Patients are then followed for 2 years
- Conditions
- Rectal Cancer, Metastasis, Radiotherapy
- Being tested
- IMRT + oral chemotherapy
- Keywords
- Intensity Modulated Radiotherapy, Simultaneous Integrated Boost, Low and middle Rectal carcinoma
- Medical subject headings
- Rectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT + oral chemotherapyCombination product
Also called Intensity-Modulated Radiotherapy + capecitabine
It's a dose escalation of radiation (IMRT), during 5 to 7 weeks, 5 days per week.
Concomitantly, patient have oral chemotherapy (capecitabin)
| Study group | Role | What they receive |
|---|---|---|
| IMRT + oral chemotherapy | Experimental | Radiotherapy = IMRT with SIB. The overall duration of irradiation is 5 to 7 weeks Chemotherapy = oral capecitabine. Chemotherapy is taken in concomitance as radiotherapy days Receives: Combination Product: IMRT + oral chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated radiation dose (MTD) delivered by IMRT with SIB, in combination with oral capecitabine, for initially metastatic, low and middle rectal cancer after 4 induction cycles of mFolfox6 regimen.
MTD = dose level -1 after at least 2 patients with DLT to upper level
Measured: 84 months
Secondary outcomes (7)
Local Progression-free survival at 12 months,
% patient with Local Progression at CT scan, 12 months after inclusion
Measured: 12 months after inclusion
Toxicity profile of the chemoradiation step for NCI.CTC grade 3-4 local toxicities due to "Pelvic Radiation Disease"
% patient with >= grade 3 toxicity (NCI.CTC AE)
Measured: 84 months
To evaluate quality of Life
EORTC-QLQC-30
Measured: 84 months
To evaluate quality of Life
QLQ-CR29
Measured: 84 months
Overall survival at 2 years
Overall survival is defined as the delay between the date of inclusion and the date of end of study
Measured: 24 months after inclusion
The usefulness of surgery
The surgical decision within 12 months after the end of radiochemotherapy will be recovered
Measured: 12 months after the end of radiochemotherapy
The prognostic value of PET
The interest of PET to define the volume in radiotherapy
Measured: 108 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start5 May 2015
- Primary completion10 Dec 2018
- Study completion10 Dec 2018
Why it stopped: the study was stopped for lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase-1 study of escalade dose of radiation
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AMAURY PAUMIER, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634202
- Sponsor's protocol ID
- ICO-A-2013-06
- Acronym
- DESIR
- Status last verified
- May 2019
- First submitted
- 6 Aug 2018
- Last updated
- 15 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-1 Study of Escalated-dose Pelvic Radiation Therapy Using Intensity-Modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB), in Combination With Xeloda, for Initially Metastatic, Low and Middle Rectal Cancer
- ClinicalTrials.gov ID
- NCT03634202
- Acronym / sponsor ID
- DESIR / ICO-A-2013-06
- Conditions
- Rectal Cancer, Metastasis, Radiotherapy
- Keywords
- Intensity Modulated Radiotherapy, Simultaneous Integrated Boost, Low and middle Rectal carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study was stopped for lack of inclusion
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 5 May 2015 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In initially metastatic rectal carcinoma, a neo-adjuvant multi-drug chemotherapy is usually performed, followed by a pelvic chemoradiation. The surgical indications on both metastases and the pelvic site are then discussed: in the case where a complete (or near-complete) response (CR) of the rectal tumor is observed (10 to 40%), the local surgery may be omitted or poned ("wait-and-see") in a sphincter-sparing strategy, in order to minimize or avoid the surgical morbidity, to focus on metastatic disease by the continuation of chemotherapy, and to preserve a better quality of life. After 8 weeks of induction chemotherapy (mFolfox6 regimen, 4 cycles), the aim of our study is to optimize the chemoradiation step on the distal rectal tumor, thanks to Intensity-Modulated Radiotherapy (IMRT) with simultaneous integrated boost (SIB) (Phase-1 part of the study), concomitantly with oral capecitabine. According to a Fibonacci dose-escalation scheme, 3 radiation dose-levels are defined, up to the definition of the maximal tolerated dose (MTD), requiring the inclusion of a maximum of 20 patients. Further patients will be included at the recommended dose for phase-2 (RDP2) in a two-step phase-2 study, considering simultaneously as principal objective at 12 months, both the efficacy (local CR rate in the range of 10 to 25%) and the tolerance (pelvic radiation disease: grade 3-4 toxicities in the range of 30 to 10%). Overall 65 patients will be included in the phase-2 study at the RDP2 dose.
Detailed description
The study population has metastatic rectal cancer. After obtaining informed consent and if they fulfil all of the criteria for inclusion, patients will be included.
After 8 weeks of induction chemotherapy with FOLFOX, patients perform an imaging assessment.
Then they are treated by radiotherapy with an oral Xeloda At the end of irradiation, patients realize on other Imaging assessment. Patients are then followed for 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase-1 study of escalade dose of radiation
| Arm | Type | Receives |
|---|---|---|
| IMRT + oral chemotherapy | Experimental | Combination Product: IMRT + oral chemotherapyRadiotherapy = IMRT with SIB. The overall duration of irradiation is 5 to 7 weeks Chemotherapy = oral capecitabine. Chemotherapy is taken in concomitance as radiotherapy days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Metastatic distal rectal carcinoma (low and middle);
- age >18 years
- Estimated life expectancy greater than 3 months
- PS: ECOG<2
- Normal hematologic, renal and hepatic functions
Key exclusion criteria (11 listed)
- No previous treatment with pelvic radiotherapy or chemotherapy
- Disorder precluding understanding of trial information or informed consent
- No severe or uncontrolled disease (infection, VIH, HBs, diabetes mellitus)
- No peripheral neuropathy > grade 2
- No inflammatory disease or fructosemia
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 |
|---|---|---|
| IMRT + oral chemotherapyAlso: Intensity-Modulated Radiotherapy + capecitabineIt's a dose escalation of radiation (IMRT), during 5 to 7 weeks, 5 days per week. Concomitantly, patient have oral chemotherapy (capecitabin) | Combination product | IMRT + oral chemotherapy |
Primary outcome
maximum tolerated radiation dose (MTD) delivered by IMRT with SIB, in combination with oral capecitabine, for initially metastatic, low and middle rectal cancer after 4 induction cycles of mFolfox6 regimen.
Time frame: 84 months
MTD = dose level -1 after at least 2 patients with DLT to upper level
7 secondary outcomes
Local Progression-free survival at 12 months,
Time frame: 12 months after inclusion
Toxicity profile of the chemoradiation step for NCI.CTC grade 3-4 local toxicities due to "Pelvic Radiation Disease"
Time frame: 84 months
To evaluate quality of Life
Time frame: 84 months
To evaluate quality of Life
Time frame: 84 months
Overall survival at 2 years
Time frame: 24 months after inclusion
The usefulness of surgery
Time frame: 12 months after the end of radiochemotherapy
The prognostic value of PET
Time frame: 108 months
Results and safety
The study was stopped early (reason given: the study was stopped for lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- 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.
AMAURY PAUMIER, MD principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMRT + oral chemotherapy in people with Rectal Cancer and Metastasis, run by Institut Cancerologie de l'Ouest at 1 site 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: the study was stopped for lack of inclusion). Results are not available in the source record.
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?
maximum tolerated radiation dose (MTD) delivered by IMRT with SIB, in combination with oral capecitabine, for initially metastatic, low and middle rectal cancer after 4 induction cycles of mFolfox6 regimen. (time frame: 84 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 15 May 2019.