|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01333709 |
|
Date of registration:
|
08/04/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Multicenter Phase 2 Trial: a Tailored Strategy for Locally Advanced Rectal Carcinoma
GRECCAR4 |
|
Scientific title:
|
A Randomized Multicenter Phase 2 Study: a Tailored Strategy for Locally Advanced Rectal Carcinoma |
|
Date of first enrolment:
|
May 2011 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01333709 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Philippe ROUANET, MD., Ph D |
|
Address:
|
|
|
Telephone:
|
+33 467 61 31 14 |
|
Email:
|
Philippe.Rouanet@valdorel.fnclcc.fr |
|
Affiliation:
|
|
|
|
Name:
|
Philippe ROUANET, MD, Ph D |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CRLC Val d'Aurelle-Paul Lamarque |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Histologically confirmed rectal carcinoma
- Primary tumor evaluated by pelvic MR Imaging:
i) iT3 =c tumors, with MRI showing a predictive CRM = 2 mm or a EMS (Extra Mural
Spread) = 5 mm
ii) Resectable iT4 tumors (only randomized within the "poor responders" group)
iii) Any T tumors with MRI showing a predictive CRM = 1 mm
- No detectable metastases: Thorax-abdomen-pelvic CT-scan
- 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
Exclusion Criteria:
- 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
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Locally Advanced Malignant Neoplasm
|
|
Rectal Carcinoma
|
|
Intervention(s)
|
|
Drug: Induction trichemotherapy - FOLFIRINOX regimen
|
|
Other: Early tumor response evaluation by MRI volumetry
|
|
Procedure: Radical proctectomy with total mesorectal excision
|
|
Radiation: Radiochemotherapy Cap 50
|
|
Radiation: Radiochemotherapy Cap 60
|
|
Primary Outcome(s)
|
|
Ro resection rate
[Time Frame: Within 15 days after surgery]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Compliance rate with neoadjuvant treatment schedule
[Time Frame: Within 4 months after the start of treatment]
|
|
Efficiency of MRI for prognosis
[Time Frame: Within 15 days after the surgery]
|
|
Functional outcome
[Time Frame: For a 5-year follow-up]
|
|
Incidence of metastases
[Time Frame: For a 5-year follow-up]
|
|
Local recurrence rate
[Time Frame: For a 5-year follow-up]
|
|
Pathological complete response rate
[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]
|
|
Quality of life
[Time Frame: For a 5-year follow-up]
|
|
Sphincter-saving surgery rate
[Time Frame: Up to 2 months after the end of the neoadjuvant treatment]
|
|
Tumor regression grade (TRG)
[Time Frame: Within 15 days after surgery]
|
|
Secondary ID(s)
|
|
2010-023546-73
|
|
GRECCAR 4
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|