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出境医 / 临床实验 / Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems (DWI_RECT_MRGRT)
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems (DWI_RECT_MRGRT)
Study Description
Brief Summary:
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
| Condition or disease | Intervention/treatment |
|---|---|
| Rectal Adenocarcinoma | Device: MRI-guided radiotherapy by on-board DWI sequences |
Detailed Description:
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 39 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems |
| Actual Study Start Date : | June 8, 2020 |
| Estimated Primary Completion Date : | May 2022 |
| Estimated Study Completion Date : | May 2027 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
non-metastatic rectal adenocarcinoma nRCT indicated
Patients with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated.
|
Device: MRI-guided radiotherapy by on-board DWI sequences
The radiotherapy treatment will be delivered on the MRI-guided radiotherapy platform. The on-board DWI sequences will be performed every three fractions in addition to the treatment session and will last approximately 3-4 minutes.
|
Outcome Measures
Primary Outcome Measures :
- Predictive value of Apparent Diffusion Coefficient measured using MRgRT system [ Time Frame: At surgery (5 to 10 weeks after completion of chemoradiation) ]Pathological complete response using AJCC criteria
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The study population consists of men and / or women over 18 years of age, with no upper limit age, with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated.
Criteria
Inclusion Criteria:
- Patient over 18 years old.
- Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.
- Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1
- Signed consent to participation.
- For women of childbearing age, effective contraception must also be agreed for the duration of treatment.
- Affiliation to a social security regimen, or beneficiary of such a regimen.
Exclusion Criteria:
- Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.
- Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).
- Exclusive radiation therapy.
- Other associated neo-adjuvant treatment.
- Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.
- Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance <30 ml / min),
- Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU / capecitabine and / or its excipients.
- Participation in a protocol with concurrent treatment.
- Pregnant or likely to be pregnant (without effective contraception) or breastfeeding
- Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent.
- Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.
Contacts and Locations
Contacts
| Contact: Dominique GENRE, MD | 33491223778 | DRCI.UP@ipc.unicancer.fr | |
| Contact: Margot BERLINE, MSc, MBA | 33491223778 | DRCI.UP@ipc.unicancer.fr |
Locations
| United States, California | |
| University of California Los Angeles (UCLA) | Not yet recruiting |
| Los Angeles, California, United States, 90095-1406 | |
| Contact: Percy LEE, MD | |
| Principal Investigator: Percy LEE | |
| France | |
| Institut Paoli Calmettes | Recruiting |
| Marseille, Bouches Du Rhone, France, 13009 | |
| Contact: Dominique Genre, MD 0033491223778 drci.up@ipc.unicancer.fr | |
| Contact: Caroline Gouarné, PhD 0033491223778 drci.up@ipc.unicancer.fr | |
| Principal Investigator: Marguerite TYRAN | |
Sponsors and Collaborators
Institut Paoli-Calmettes
University of California, Los Angeles
Investigators
| Principal Investigator: | Marguerite TYRAN, MD | Institut Paoli-Calmettes |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 20, 2019 | ||||||||
| First Posted Date | May 23, 2019 | ||||||||
| Last Update Posted Date | May 6, 2021 | ||||||||
| Actual Study Start Date | June 8, 2020 | ||||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Predictive value of Apparent Diffusion Coefficient measured using MRgRT system [ Time Frame: At surgery (5 to 10 weeks after completion of chemoradiation) ] Pathological complete response using AJCC criteria
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems | ||||||||
| Official Title | Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems | ||||||||
| Brief Summary | feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma. | ||||||||
| Detailed Description | feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The study population consists of men and / or women over 18 years of age, with no upper limit age, with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated. | ||||||||
| Condition | Rectal Adenocarcinoma | ||||||||
| Intervention | Device: MRI-guided radiotherapy by on-board DWI sequences
The radiotherapy treatment will be delivered on the MRI-guided radiotherapy platform. The on-board DWI sequences will be performed every three fractions in addition to the treatment session and will last approximately 3-4 minutes.
|
||||||||
| Study Groups/Cohorts | non-metastatic rectal adenocarcinoma nRCT indicated
Patients with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated.
Intervention: Device: MRI-guided radiotherapy by on-board DWI sequences
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
39 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | May 2027 | ||||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | France, United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03961776 | ||||||||
| Other Study ID Numbers | DWI_RECT_MRGRT-IPC 2019-002 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Institut Paoli-Calmettes | ||||||||
| Study Sponsor | Institut Paoli-Calmettes | ||||||||
| Collaborators | University of California, Los Angeles | ||||||||
| Investigators |
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| PRS Account | Institut Paoli-Calmettes | ||||||||
| Verification Date | May 2021 | ||||||||
