Locally Advanced Malignant NeoplasmPhase 2GRECCAR4NCT01333709
Multicenter Phase 2 Trial: a Tailored Strategy for Locally Advanced Rectal Carcinoma
A Phase 2 study testing Induction trichemotherapy - FOLFIRINOX regimen, Early tumor response evaluation by MRI volumetry and Radiochemotherapy Cap 50 in people with Locally Advanced Malignant Neoplasm and Rectal Carcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The purpose of this study is to determine whether the tailored management of locally advanced rectal carcinoma can improve the oncologic and functional outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Malignant Neoplasm, Rectal Carcinoma
- What is being tested?
- Induction trichemotherapy - FOLFIRINOX regimen, Early tumor response evaluation by MRI volumetry and Radiochemotherapy Cap 50
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Sep 2014
- Phase
- Phase 2
- 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
- Histologically confirmed rectal carcinoma
- Primary tumor evaluated by pelvic MR Imaging:
- iT3 ≥c tumors, with MRI showing a predictive CRM ≤ 2 mm or a EMS (Extra Mural Spread) ≥ 5 mm
- Resectable iT4 tumors (only randomized within the "poor responders" group)
- Any T tumors with MRI showing a predictive CRM ≤ 1 mm
- No detectable metastases: Thorax-abdomen-pelvic CT-scan
Show all 15Show fewer
- Patient ≥ 18 years
- ECOG Performance Status 0-1-2
- Patient information and written informed consent form signed
- Patient who can receive radiotherapy and chemotherapy
- Negative pregnancy test in women of childbearing potential
- Patient covered by a Social Security system
- Hematology : Haemoglobin ≥ 9 g/dL, WBC ≥ 4000/mm3, neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
- Hepatic function : total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN, Alkaline phosphatases ≤ 3 x ULN
- Renal function : creatinine ≤ 1.25 x ULN or creatinine clearance ≥ 60 ml/min
Who cannot join
- Indication for immediate surgery
- Primary tumor not measured at the MRI before inclusion
- Previous pelvic radiotherapy
- Contraindication to radiotherapy and/or chemotherapy
- Severe renal or liver impairment
- Cardiac and/or coronary disease which could contraindicate 5-Fu administration
Show all 12Show fewer
- Active infectious disease
- Peripheral sensitive neuropathy
- History of prior cancer (except if it was cured more than 5 years ago, and if complete remission)
- Patient (male or female) of reproductive potential not using an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment
- Concurrent participation in any other clinical trial likely to interfere with the therapeutic schedule
- Fertile female patient not using adequate contraception, or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Multicenter Phase 2 Study: a Tailored Strategy for Locally Advanced Rectal Carcinoma
The purpose of this study is to determine whether the tailored management of locally advanced rectal carcinoma can improve the oncologic and functional outcome.
Read the detailed description
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response.
The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction trichemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders.
"Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50). "Good or bad" responders will be randomized between two arms: intensive radiochemotherapy (Cap 60) or the standard arm (Cap 50).
This tailored management should result in a better oncologic prognosis with a lower rate of post therapeutic functional disorders.
- Being tested
- Induction trichemotherapy - FOLFIRINOX regimen, Early tumor response evaluation by MRI volumetry, Radiochemotherapy Cap 50, Radiochemotherapy Cap 60, Radical proctectomy with total mesorectal excision
- Keywords
- locally advanced rectal carcinoma, Tailored treatment strategy, MRI volumetry, Early tumor response
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction trichemotherapy - FOLFIRINOX regimenDrug
A short (4 cycles) and intensive trichemotherapy combinig irinotecan 180 mg/m2, oxaliplatin 85 mg/m2, elvorin 200 mg/m2, 5-Fu (bolus 400 mg/m2, followed by a 46-hour continuous infusion 2,400 mg/m2) will be delivered for 8 weeks (D1=D15).
Early tumor response evaluation by MRI volumetryOther
Two weeks after the CT completion, the tumor volume will be measured by MRI with specific software which automatically borders the tumor so as to determine the early tumor response. A centralized reassessment of all MRI exams will be systematically performed by two radiologists of the coordinator center.
Radiochemotherapy Cap 50Radiation
RCT Cap 50 will combine radiotherapy at a dose of 50 Gy by either conventional 3D or IMRT (2 Gy per fraction, 5 fractions per week during 5 weeks / 44 Gy in mini pelvis, and boost 6 Gy on reduced peritumoral volume) with concomitant oral capecitabine at 1600 mg/m2 per day delivered the days of RT treatment (2 daily intake).
Radiochemotherapy Cap 60Radiation
RCT Cap 60 will combine radiotherapy at a dose of 60 Gy by either conventional 3D or IMRT (2 Gy per fraction, 5 fractions per week during 6 weeks / 44 Gy in mini pelvis, and boost 16 Gy on reduced peritumoral volume) with concomitant oral capecitabine at 1600 mg/m2 per day delivered the days of RT treatment (2 daily intake)
Radical proctectomy with total mesorectal excisionProcedure or surgery
The proctectomy can be performed by laparoscopic surgery or conventional laparotomy.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: immediate rectal surgery | Experimental | "Very good" responder patients will be randomly assigned to proctectomy within 2-4 weeks after the end of the induction chemotherapy. Receives: Drug: Induction trichemotherapy - FOLFIRINOX regimen; Other: Early tumor response evaluation by MRI volumetry; Procedure: Radical proctectomy with total mesorectal excision |
| Arm B: RCT Cap 50 and then rectal surgery | Other | "Very good" responder patients will be randomly assigned to receive chemoradiotherapy combining the administration of oral capecitabine (1600 mg/m2/day, BID) and radiotherapy at a total dose of 50 grays (2Gy/day, 5 days a week, 5 weeks, boost 6 Gy). Receives: Drug: Induction trichemotherapy - FOLFIRINOX regimen; Other: Early tumor response evaluation by MRI volumetry; Radiation: Radiochemotherapy Cap 50; Procedure: Radical proctectomy with total mesorectal excision |
| Arm C: RCT Cap 50 and then rectal surgery | Other | "Good or poor" responder patients will be randomly assigned to receive chemoradiotherapy combining the administration of oral capecitabine (1600 mg/m2/day, BID) and radiotherapy at a total dose of 50 grays (2Gy/day, 5 days a week, 5 weeks, boost 6 Gy). Receives: Drug: Induction trichemotherapy - FOLFIRINOX regimen; Other: Early tumor response evaluation by MRI volumetry; Radiation: Radiochemotherapy Cap 50; Procedure: Radical proctectomy with total mesorectal excision |
| Bras D: RCT Cap 60 and then rectal surgery | Experimental | "Good or poor" responder patients will be randomly assigned to receive chemoradiotherapy combining the administration of oral capecitabine (1600 mg/m2/day, BID) and radiotherapy at a total dose of 60 grays (2Gy/day, 5 days a week, 6 weeks, boost 14 Gy). Receives: Drug: Induction trichemotherapy - FOLFIRINOX regimen; Other: Early tumor response evaluation by MRI volumetry; Radiation: Radiochemotherapy Cap 60; Procedure: Radical proctectomy with total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ro resection rate
To confirm the feasibility of a tailored management with a 90% R0 resection rate achieved for all arms.
Measured: Within 15 days after surgery
Secondary outcomes (11)
Efficiency of MRI for prognosis
To specify the efficiency of MRI for prognosis in terms of volumetry, downstaging, downsizing and CRM measurement after completion of the induction trichemotherapy.
Measured: Within 15 days after the surgery
Compliance rate with neoadjuvant treatment schedule
To measure the compliance rate to the whole neoadjuvant schedule (induction CT + radiochemotherapy)
Measured: Within 4 months after the start of treatment
Acute and late toxicity of neoadjuvant treatments
To evaluate overall toxicity of neoadjuvant treatments (induction trichemotherapy + radiochemotherapy) according to the Common Terminology Criteria for Adverse Events v4.0 (NCI CTC v4.0).
Measured: For the duration of treatment, as expexcted to be up to 4 months and within the 5-year follow-up
Pathological complete response rate
To assess the pathological complete response rate (ypT0N0)
Measured: Within 15 days after surgery
Tumor regression grade (TRG)
To assess at pathologic examination the tumor regression grade (TRG) according to the Dworak classification.
Measured: Within 15 days after surgery
Perioperative and postoperative morbidity
To assess the impact of the therapeutic strategy on perioperative and postoperative morbidity.
Measured: Within 6 weeks after surgery and during the 5-year follow-up
Sphincter-saving surgery rate
To assess the impact of the therapeutic strategy on the rate of sphincter-saving surgery.
Measured: Up to 2 months after the end of the neoadjuvant treatment
Functional outcome
To assess the long-term digestive,urinary and sexual functional results of tailored strategy
Measured: For a 5-year follow-up
Quality of life
To assess the impact of treatments on quality of life according to the EORTC QLQ-C30.
Measured: For a 5-year follow-up
Local recurrence rate
To measure the local recurrence rate in each treatment arm.
Measured: For a 5-year follow-up
Incidence of metastases
To measure the incidence of distant metastases (liver, pulmonary, peritoneal, ganglionnary or any others) in each treatment arm.
Measured: For a 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Malignant NeoplasmStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe ROUANET, MD, Ph D, Principal investigator, CRLC Val d'Aurelle-Paul Lamarque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333709
- Sponsor's protocol ID
- GRECCAR 4
- Other IDs
- 2010-023546-73
- Acronym
- GRECCAR4
- Status last verified
- Aug 2017
- First submitted
- 8 Apr 2011
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; GRECCAR Study Group*. Tailored Strategy for Locally Advanced Rectal Carcinoma (GRECCAR 4): Long-term Results From a Multicenter, Randomized, Open-Label, Phase II Trial. Dis Colon Rectum. 2022 Aug 1;65(8):986-995. doi: 10.1097/DCR.0000000000002153. Epub 2022 Jul 5.
PubMed 34759247Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; and the GRECCAR Study Group. Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial. Dis Colon Rectum. 2017 Jul;60(7):653-663. doi: 10.1097/DCR.0000000000000849.
PubMed 28594714
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Phase 2 Study: a Tailored Strategy for Locally Advanced Rectal Carcinoma
- ClinicalTrials.gov ID
- NCT01333709
- Acronym / sponsor ID
- GRECCAR4 / GRECCAR 4
- Keywords
- locally advanced rectal carcinoma, Tailored treatment strategy, MRI volumetry, Early tumor response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Apr 2011 (estimated)
- 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.
The purpose of this study is to determine whether the tailored management of locally advanced rectal carcinoma can improve the oncologic and functional outcome.
Detailed description
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response.
The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction trichemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders.
"Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50). "Good or bad" responders will be randomized between two arms: intensive radiochemotherapy (Cap 60) or the standard arm (Cap 50).
This tailored management should result in a better oncologic prognosis with a lower rate of post therapeutic functional disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: immediate rectal surgery | Experimental | Drug: Induction trichemotherapy - FOLFIRINOX regimen, Other: Early tumor response evaluation by MRI volumetry, Procedure: Radical proctectomy with total mesorectal excision"Very good" responder patients will be randomly assigned to proctectomy within 2-4 weeks after the end of the induction chemotherapy. |
| Arm B: RCT Cap 50 and then rectal surgery | Other | Drug: Induction trichemotherapy - FOLFIRINOX regimen, Other: Early tumor response evaluation by MRI volumetry, Radiation: Radiochemotherapy Cap 50, Procedure: Radical proctectomy with total mesorectal excision"Very good" responder patients will be randomly assigned to receive chemoradiotherapy combining the administration of oral capecitabine (1600 mg/m2/day, BID) and radiotherapy at a total dose of 50 grays (2Gy/day, 5 days a week, 5 weeks, boost 6 Gy). |
| Arm C: RCT Cap 50 and then rectal surgery | Other | Drug: Induction trichemotherapy - FOLFIRINOX regimen, Other: Early tumor response evaluation by MRI volumetry, Radiation: Radiochemotherapy Cap 50, Procedure: Radical proctectomy with total mesorectal excision"Good or poor" responder patients will be randomly assigned to receive chemoradiotherapy combining the administration of oral capecitabine (1600 mg/m2/day, BID) and radiotherapy at a total dose of 50 grays (2Gy/day, 5 days a week, 5 weeks, boost 6 Gy). |
| Bras D: RCT Cap 60 and then rectal surgery | Experimental | Drug: Induction trichemotherapy - FOLFIRINOX regimen, Other: Early tumor response evaluation by MRI volumetry, Radiation: Radiochemotherapy Cap 60, Procedure: Radical proctectomy with total mesorectal excision"Good or poor" responder patients will be randomly assigned to receive chemoradiotherapy combining the administration of oral capecitabine (1600 mg/m2/day, BID) and radiotherapy at a total dose of 60 grays (2Gy/day, 5 days a week, 6 weeks, boost 14 Gy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed rectal carcinoma
- Primary tumor evaluated by pelvic MR Imaging:
- Resectable iT4 tumors (only randomized within the "poor responders" group)
- Any T tumors with MRI showing a predictive CRM ≤ 1 mm
- No detectable metastases: Thorax-abdomen-pelvic CT-scan
Key exclusion criteria (12 listed)
- Indication for immediate surgery
- Primary tumor not measured at the MRI before inclusion
- Previous pelvic radiotherapy
- Contraindication to radiotherapy and/or chemotherapy
- Severe renal or liver impairment
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 |
|---|---|---|
| Induction trichemotherapy - FOLFIRINOX regimenA short (4 cycles) and intensive trichemotherapy combinig irinotecan 180 mg/m2, oxaliplatin 85 mg/m2, elvorin 200 mg/m2, 5-Fu (bolus 400 mg/m2, followed by a 46-hour continuous infusion 2,400 mg/m2) will be delivered for 8 weeks (D1=D15). | Drug | Arm A: immediate rectal surgery, Arm B: RCT Cap 50 and then rectal surgery, Arm C: RCT Cap 50 and then rectal surgery, Bras D: RCT Cap 60 and then rectal surgery |
| Early tumor response evaluation by MRI volumetryTwo weeks after the CT completion, the tumor volume will be measured by MRI with specific software which automatically borders the tumor so as to determine the early tumor response. A centralized reassessment of all MRI exams will be systematically performed by two radiologists of the coordinator center. | Other | Arm A: immediate rectal surgery, Arm B: RCT Cap 50 and then rectal surgery, Arm C: RCT Cap 50 and then rectal surgery, Bras D: RCT Cap 60 and then rectal surgery |
| Radiochemotherapy Cap 50RCT Cap 50 will combine radiotherapy at a dose of 50 Gy by either conventional 3D or IMRT (2 Gy per fraction, 5 fractions per week during 5 weeks / 44 Gy in mini pelvis, and boost 6 Gy on reduced peritumoral volume) with concomitant oral capecitabine at 1600 mg/m2 per day delivered the days of RT treatment (2 daily intake). | Radiation | Arm B: RCT Cap 50 and then rectal surgery, Arm C: RCT Cap 50 and then rectal surgery |
| Radiochemotherapy Cap 60RCT Cap 60 will combine radiotherapy at a dose of 60 Gy by either conventional 3D or IMRT (2 Gy per fraction, 5 fractions per week during 6 weeks / 44 Gy in mini pelvis, and boost 16 Gy on reduced peritumoral volume) with concomitant oral capecitabine at 1600 mg/m2 per day delivered the days of RT treatment (2 daily intake) | Radiation | Bras D: RCT Cap 60 and then rectal surgery |
| Radical proctectomy with total mesorectal excisionThe proctectomy can be performed by laparoscopic surgery or conventional laparotomy. | Procedure or surgery | Arm A: immediate rectal surgery, Arm B: RCT Cap 50 and then rectal surgery, Arm C: RCT Cap 50 and then rectal surgery, Bras D: RCT Cap 60 and then rectal surgery |
Primary outcome
Ro resection rate
Time frame: Within 15 days after surgery
To confirm the feasibility of a tailored management with a 90% R0 resection rate achieved for all arms.
11 secondary outcomes
Efficiency of MRI for prognosis
Time frame: Within 15 days after the surgery
Compliance rate with neoadjuvant treatment schedule
Time frame: Within 4 months after the start of treatment
Acute and late toxicity of neoadjuvant treatments
Time frame: For the duration of treatment, as expexcted to be up to 4 months and within the 5-year follow-up
Pathological complete response rate
Time frame: Within 15 days after surgery
Tumor regression grade (TRG)
Time frame: Within 15 days after surgery
Perioperative and postoperative morbidity
Time frame: Within 6 weeks after surgery and during the 5-year follow-up
Sphincter-saving surgery rate
Time frame: Up to 2 months after the end of the neoadjuvant treatment
Functional outcome
Time frame: For a 5-year follow-up
Quality of life
Time frame: For a 5-year follow-up
Local recurrence rate
Time frame: For a 5-year follow-up
Incidence of metastases
Time frame: For a 5-year follow-up
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 21 Aug 2017.
- Derived from this study: PubMed 34759247Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; GRECCAR Study Group*. Tailored Strategy for Locally Advanced Rectal Carcinoma (GRECCAR 4): Long-term Results From a Multicenter, Randomized, Open-Label, Phase II Trial. Dis Colon Rectum. 2022 Aug 1;65(8):986-995. doi: 10.1097/DCR.0000000000002153. Epub 2022 Jul 5.
- Derived from this study: PubMed 28594714Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; and the GRECCAR Study Group. Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial. Dis Colon Rectum. 2017 Jul;60(7):653-663. doi: 10.1097/DCR.0000000000000849.
Related trials for Locally Advanced Malignant Neoplasm
Not yet recruitingPhase 2
Exploratory Study of Short-Course Radiotherapy Followed by Adebrelimab Combined With Chemotherapy for Organ Preservation in Locally Advanced Rectal Cancer
Locally Advanced Resectable Rectal Cancer
Active, not recruitingPhase 1
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
Advanced Cervical Adenocarcinoma, Advanced Cervical Adenosquamous Carcinoma
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
Not yet recruitingPhase 2
Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate Cancer
Prostate Cancer (Adenocarcinoma)
RecruitingPhase 1/2
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
Non-Small Cell Lung Cancer, NSCLC
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.
Philippe ROUANET, MD, Ph D principal investigator
CRLC Val d'Aurelle-Paul Lamarque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Induction trichemotherapy - FOLFIRINOX regimen, Early tumor response evaluation by MRI volumetry and Radiochemotherapy Cap 50 in people with Locally Advanced Malignant Neoplasm and Rectal Carcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 15 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 21 Aug 2017. 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.
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?
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?
Ro resection rate (time frame: Within 15 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01333709, which also lists 2 linked publications.
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 21 Aug 2017.