Advanced Rectal CancersRADICALNCT03200249
Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers
A study testing Preoperative chemo-radiation with IG-IMRT dose escalation in people with Advanced Rectal Cancers, run by Centre Georges Francois Leclerc at 2 sites in France.
Trial summary
Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Rectal Cancers
- What is being tested?
- Preoperative chemo-radiation with IG-IMRT dose escalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Dec 2016to 7 Jan 2020
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommends preoperative radiochemotherapy
- Tumor <15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI
- Tumor potentially resectable from the outset, or considered to be resectable after radiochemotherapy
- Operable Patient
- Age between 18 and 75
- OMS performance status 0-2
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- No co-morbidity likely to prevent the delivery of treatment
- Adequate contraception for men, and for non-menopausal women
- Neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dL
- Bilirubin ≤ 1.5 times the upper limit of normal (LNS), ASAT and ALAT ≤ 1.5LNS, Alkaline phosphatase ≤ 1.5 LNS
- Creatinine clearance> 50 mL / min
- Patient must have been informed and must have signed the specific informed consent form.
- Patient must be affiliated to a Social Health Insurance.
Who cannot join
- Remote metastasis
- Cancer not resectable
- Contraindication to capecitabine and its excipients
- Previous history of pelvic radiotherapy or previous chemotherapy
- History of inflammatory bowel or rectum disease
- History of angina pectoris monitored or myocardial infarction or heart failure
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- Active active infection or other serious underlying condition that may prevent the patient from receiving treatment
- Other concomitant cancer, or history of cancer other than in situ cancer of the treated cervix or basal cell carcinoma or squamous cell carcinoma
- Patient already included in another therapeutic trial with an experimental molecule
- Pregnant woman, likely to be pregnant or nursing
- Persons deprived of their liberty or under guardianship
- Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)
Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis
Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or cN1-2.
- Conditions
- Advanced Rectal Cancers
- Being tested
- Preoperative chemo-radiation with IG-IMRT dose escalation
- Keywords
- dose escalation, chemo-radiation, rectum cancer, phase 2
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative chemo-radiation with IG-IMRT dose escalationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 1. - Treatment : concomitant preoperative radio-chemotherapy (during 5 weeks)
Chimiotherapy: Capecitabine 1600 mg/m2/j ; 5/7 days during the 5 weeks of radiotherapy
Radiotherapy RT + SIB-IMRT (5 weeks ; 5 sessions/week ; 25 sessions): Pelvic prophylactic dose of 45 Gy (1,8 Gy/session); "boost" with a dose of 60 Gy on the tumor PTV (2,4 Gy/session) - Total dose: 60 Gy in 25 sessions during 5 weeks.
2. - TME surgery (8 weeks after the end of treatment) Receives: Radiation: Preoperative chemo-radiation with IG-IMRT dose escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete histological response rate
Absence of residual cancer cells on the final analysis of the tumor and lymph node
Measured: at 8 weeks after inclusion
Secondary outcomes (1)
Tolerance
Toxicity is assessed according to the NCI-CTCAE toxicity scale version 4.0
Measured: at 1, 2, 3, 4, 5 and 13 weeks after inclusion and at 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start22 Dec 2016
- Primary completion22 Dec 2016
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Rectal CancersStudies 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200249
- Sponsor's protocol ID
- 2016-A01083-48
- Acronym
- RADICAL
- Status last verified
- Jan 2020
- First submitted
- 20 Jun 2017
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)
- ClinicalTrials.gov ID
- NCT03200249
- Acronym / sponsor ID
- RADICAL / 2016-A01083-48
- Conditions
- Advanced Rectal Cancers
- Keywords
- dose escalation, chemo-radiation, rectum cancer, phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 27 Jun 2017 (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.
Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis
Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or cN1-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Preoperative chemo-radiation with IG-IMRT dose escalation1. - Treatment : concomitant preoperative radio-chemotherapy (during 5 weeks) Chimiotherapy: Capecitabine 1600 mg/m2/j ; 5/7 days during the 5 weeks of radiotherapy Radiotherapy RT + SIB-IMRT (5 weeks ; 5 sessions/week ; 25 sessions): Pelvic prophylactic dose of 45 Gy (1,8 Gy/session); "boost" with a dose of 60 Gy on the tumor PTV (2,4 Gy/session) - Total dose: 60 Gy in 25 sessions during 5 weeks. 2. - TME surgery (8 weeks after the end of treatment) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommends preoperative radiochemotherapy
- Tumor <15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI
- Tumor potentially resectable from the outset, or considered to be resectable after radiochemotherapy
- Operable Patient
- Age between 18 and 75
Key exclusion criteria (12 listed)
- Remote metastasis
- Cancer not resectable
- Contraindication to capecitabine and its excipients
- Previous history of pelvic radiotherapy or previous chemotherapy
- History of inflammatory bowel or rectum disease
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 |
|---|---|---|
| Preoperative chemo-radiation with IG-IMRT dose escalation | Radiation | Treatment |
Primary outcome
Complete histological response rate
Time frame: at 8 weeks after inclusion
Absence of residual cancer cells on the final analysis of the tumor and lymph node
1 secondary outcome
Tolerance
Time frame: at 1, 2, 3, 4, 5 and 13 weeks after inclusion and at 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative chemo-radiation with IG-IMRT dose escalation in people with Advanced Rectal Cancers, run by Centre Georges Francois Leclerc at 2 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 13 inclusion and 12 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 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete histological response rate (time frame: at 8 weeks after inclusion). 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 24 Jun 2020.