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New treatment option for Rectal Cancer
Official title Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
ClinicalTrials.gov ID: NCT03875781
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a non-inferiority phase III randomised trial comparing preoperative chemotherapy alone (modified FOLFIRINOX) to chemotherapy followed by chemoradiotherapy in patients with primary resectable locally advanced rectal cancer. The primary endpoint of the study is 3-year progression free survival.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically proven middle or low rectal carcinoma, ≤ 10 cm from the anal verge on MRI (sagittal slide)
- cT3N0 and/or cT1-T3N+ on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound),
- Pretreatment predictive circumferential margin \> 2mm on pretreatment imaging work up (pelvic contrast enhanced MRI)
- Patients must be 18 years old or older
- A World Health Organization (WHO/ECOG) performance status of 0 or 1
You likely can't join if
- Rectal tumor \> 10 cm from the anal verge on MRI (sagittal slide)
- cT4 tumor on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound) or involvement of external sphincter
- Circumferential margin ≤ 2 mm on pretreatment imaging work up (pelvic contrast enhanced MRI)
- Metastatic disease
- Prior pelvic irradiation or any contraindication to pelvic irradiation
- Contraindication to oxaliplatin or irinotecan or 5FU based chemotherapy
See the full eligibility criteria
- Histologically proven middle or low rectal carcinoma, ≤ 10 cm from the anal verge on MRI (sagittal slide)
- cT3N0 and/or cT1-T3N+ on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound),
- Pretreatment predictive circumferential margin \> 2mm on pretreatment imaging work up (pelvic contrast enhanced MRI)
- Patients must be 18 years old or older
- A World Health Organization (WHO/ECOG) performance status of 0 or 1
- Informed consent signed
- Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth...
- Rectal tumor \> 10 cm from the anal verge on MRI (sagittal slide)
- cT4 tumor on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound) or involvement of external sphincter
- Circumferential margin ≤ 2 mm on pretreatment imaging work up (pelvic contrast enhanced MRI)
- Metastatic disease
- Prior pelvic irradiation or any contraindication to pelvic irradiation
- Contraindication to oxaliplatin or irinotecan or 5FU based chemotherapy
- Concomitant treatment with warfarin is contraindicated and warafarin must be replaced whenever possible to allow for inclusion.
- Recent or concomitant treatment with brivudine is contraindicated
- contraindications to 5-FU: complete and permanent insufficiency in dihydropyrimidine dehydrogenase, bone marrow insufficiency, chronic and severe infection
- contraindication to irinotecan : inflammatory bowel disease, bilirubin serum level \> 3 times the upper limit of the normal rate, severe bone marrow insufficiency, WHO/ECOG performence status \> 2,
- Concomitant treatment with millepertuis.
- contraindication to oxaliplatin : \ bone marrow insufficiency before treatment initiation (neutrophil count \<2x109/L and/or platelet count \<100x109/L), peripheral neuropathy with permanent invalidity before treatment...
- severe renal insufficiency (Creatinin clearance \<30 ml/min)
- contraindications to folinic acid : Biermer anemia and other anemia related to B12 vitamin insufficiency
- contraindications to capecitabin : severe renal insufficiency (Creatinin clearance \<30 ml/min), complete and permanent insufficiency in dihydropyrimidine dehydrogenase
- live attenuated vaccine should not be used during and 6 months after preoperative treatment.
- Previous colorectal cancer
- Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for \>5 years
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient...
- protected adults
- Pregnancy or breastfeeding
- Patient with no national health or universal plan affiliation coverage.
The study team makes the final eligibility decision.
Where it's taking place
- Le Kremlin-Bicêtre, Île-de-France Region, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Kremlin-Bicêtre, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.