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Compares treatment options for Locally Advanced Rectal Cancer
Official title TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT05646511
What this study is testing
What is CAPOX?
CAPOX is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for locally advanced rectal cancer.
Also referred to as Active Comparator.
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 trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.
- 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
- The content of this research was fully explained, and written informed consent was obtained from the subject.
- Histologically confirmed rectal adenocarcinoma.
- Radical resection is clinically possible without any distant metastases on imaging studies.
- Age of 18 years or older on the date of consent acquisition.
- Eastern Cooperative Oncology Group (ECOG) PS 0-1 (PS 0 if aged 70 years or older on consent acquisition date).
You likely can't join if
- Extensive surgery (excluding colostomy and central venous port construction) within 4 weeks before starting protocol treatment.
- Complications or history of severe lung disease (such as interstitial pneumonia, pulmonary fibrosis, and severe emphysema).
- Colonic stent in place.
- Contraindications for MRI such as cardiac pacemakers.
- Serious comorbidities (such as heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, and...
- Patients with multiple active cancers (simultaneous multiple cancers or metachronous multiple cancers with a disease-free interval of 5 years or...
See the full eligibility criteria
- The content of this research was fully explained, and written informed consent was obtained from the subject.
- Histologically confirmed rectal adenocarcinoma.
- Radical resection is clinically possible without any distant metastases on imaging studies.
- Age of 18 years or older on the date of consent acquisition.
- Eastern Cooperative Oncology Group (ECOG) PS 0-1 (PS 0 if aged 70 years or older on consent acquisition date).
- Inferior margin of the tumor is within 12 cm of the AV.
- No prior tumor treatment.
- No history of radiation therapy to the pelvis, including treatment for other cancer types.
- Cases with cT3-4N0M0\ or T1-4N1-2M0 based on Union Internationale Contre le Cancer (UICC) 8th edition. (\ 5 cm\< AV ≤ 10 cm, T3a/bN0M0, extramural venous invasion (EMVI) -, mesorectal fascia (MRF) clear and 10 cm \< AV...
- UGT1A1 is wild-type or single heterozygous.
- Criteria for major organ function within 28 days prior to enrollment. If there are multiple test results within this period, the most recent one will be used, and blood transfusions and hematopoietic factor preparations...
- Neutrophil count: ≥1,500/mm3
- Platelet count: ≥10.0×10 4/mm3
- Hemoglobin concentration: ≥9.0 g/dL
- Total bilirubin: ≤2.0 mg/dL
- Aspartate transaminase (AST): ≤100 IU/L or less
- Alanine transaminase (ALT): ≤100 IU/L or less
- Serum creatinine: Creatinine clearance ≥30 mL/min (by Cockcroft \& Gault formula)
- Extensive surgery (excluding colostomy and central venous port construction) within 4 weeks before starting protocol treatment.
- Complications or history of severe lung disease (such as interstitial pneumonia, pulmonary fibrosis, and severe emphysema).
- Colonic stent in place.
- Contraindications for MRI such as cardiac pacemakers.
- Serious comorbidities (such as heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, and active inflammatory bowel disease).
- Patients with multiple active cancers (simultaneous multiple cancers or metachronous multiple cancers with a disease-free interval of 5 years or less). However, carcinoma in situ or lesions equivalent to intramucosal...
- Pregnant women, lactating women, positive pregnancy test, or unwillingness to use contraception.
- Hepatitis B surface (HBs) antigen positive or hepatitis C virus (HCV) antibody-positive. However, HCV-RNA-negative can be registered.
- Have human immunodeficiency virus (HIV) infection.
- MSI-high (MSI-H) or defective mismatch repair (dMMR) is known.
- Unwilling to donate specimens for "Research on gene profiling and clinical significance using clinical specimens from cancer patients" for whole-genome analysis based on the "Action Plan for Whole-Genome Analysis, etc."...
- Any other patients the principal investigator or co-investigator deems inappropriate for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Chiba, Japan
- Ehime, Japan
- Fukuoka, Japan
- Gifu, Japan
- Hirosaki, Japan
- Hiroshima, Japan
- Kawasaki, Japan
- Kitakyushu, Japan
- Kochi, Japan
- Kumamoto, Japan
- Kyoto, Japan
- Nagoya, Japan
- Okayama, Japan
- Osaka, Japan
- Sagamihara, Japan
- Sapporo, Japan
- Tokyo, Japan
- Yokohama, Japan
- Yokosuka, Japan
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 Chiba, Japan; Ehime, Japan; Fukuoka, Japan; Gifu, Japan; Hirosaki, Japan; Hiroshima, Japan and 13 more location(s). 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.