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Compares treatment options for Rectal Cancer
Official title Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation
ClinicalTrials.gov ID: NCT03671252
What this study is testing
What is FOLFOXIRI?
FOLFOXIRI 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
- Preoperative radiation and chemotherapy is the standard treatment for local advanced rectal cancer. The addition of oxaliplatin to capecitabine combined with radiotherapy does not improve local control and long-term 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 to 75
You may be able to join if
- 1）Age: 18 to 75 years old;
- 2）Histological diagnosis of rectal adenocarcinoma;
- 3）Distance form anal margin ≤ 5cm: cT3-4aN + M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular...
- 4）From the anal margin\>5cm: cT3c-4aN+M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer with...
- 5）Preoperative staging method: All patients undergoing anal examination, high-resolution MRI and/or EUS for preoperative staging. The diameter of...
You likely can't join if
- 1）Tumor invasion of surrounding tissue organs (T4b) by preoperative staging assessment;
- 2）Obturator lymph node metastasis;
- 3）Arrhythmia requires treatment with antiarrhythmia (except for beta-blockers or digoxin), symptomatic coronary artery disease, myocardial ischemia...
- 4）Severe hypertension with poor control;
- 5）History of HIV infection or active phase of chronic hepatitis B or C infection with high copy viral DNA;
- 6）Other active serious infections according to NCI-CTC version 4.0;
See the full eligibility criteria
- 1）Age: 18 to 75 years old;
- 2）Histological diagnosis of rectal adenocarcinoma;
- 3）Distance form anal margin ≤ 5cm: cT3-4aN + M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer, no invasion of the adjacent organs , positive MRF, it is estimated...
- 4）From the anal margin\>5cm: cT3c-4aN+M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer with invading the mesorectum more than 5mm, no invasion of the adjacent...
- 5）Preoperative staging method: All patients undergoing anal examination, high-resolution MRI and/or EUS for preoperative staging. The diameter of parenteral lymph node ≥10mm, lymph node shape or the MRI characteristics...
- 6）Confirmed as the lower edge of tumor is located within 12 cm from the anal margin by MRI examination
- 7）There is no signs of intestinal obstruction, or obstruction of intestinal after treating with proximal colostomy has been relieved;
- 8）Patients did not previously receive rectal surgery, chemotherapy or radiation therapy , biological treatment , except for endocrine therapy;
- 9）ECOG Performance Status :0-1
- 10）Life expectancy: more than 2 years;
- 11）Laboratory values：Hematology: white blood cell count\>4000/mm3; Platelet count\>100000/mm3; Hemoglobin \>10g/dL; Liver function: SGOT and SGPT \< 1.5 upper limit of normal(ULN); Bilirubin\< 1.5mg/dL; Renal function...
- 1）Tumor invasion of surrounding tissue organs (T4b) by preoperative staging assessment;
- 2）Obturator lymph node metastasis;
- 3）Arrhythmia requires treatment with antiarrhythmia (except for beta-blockers or digoxin), symptomatic coronary artery disease, myocardial ischemia (myocardial infarction within the last 6 months) or congestive heart...
- 4）Severe hypertension with poor control;
- 5）History of HIV infection or active phase of chronic hepatitis B or C infection with high copy viral DNA;
- 6）Other active serious infections according to NCI-CTC version 4.0;
- 7）There is preoperative evidence for distant metastasis outside pelvis;
- 8）Cachexia and organ function decompensation
- 9）History of pelvic or abdominal radiotherapy;
- 10）Multiple primary cancer;
- 11）Patients with epilepcy requiring treatment ( steroids or antiepileptic treatment);
- 12）History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or skin basal cell carcinoma;
- 13）Drug abuse and medical, psychological or social conditions interfering patient participation in research or the evaluation of research results;
- 14）Any allergy to clinical research drugs or any drugs associated with this study;
- 15）Any unstable condition or condition that may endanger safety and compliance of patients;
- 16）Pregnancy or the lactating female without adequate contraception.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. 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.