What is this trial studying for locally advanced rectal cancer?

This trial is comparing two preoperative treatment combinations involving short-course radiation and chemotherapy to see which better helps patients with locally advanced rectal cancer. It aims to find out if adding irinotecan to the chemotherapy improves outcomes before surgery. The study is sponsored by the National Cancer Center Hospital East.

Who may be eligible for this locally advanced rectal cancer clinical trial?

Adults aged 18 years or older with confirmed rectal adenocarcinoma and no distant metastases may be eligible. Both men and women can participate if they have good performance status and no prior pelvic radiation. Certain organ function and genetic factors are also required. Please review eligibility criteria for more details.

Is there any cost to participate in this locally advanced rectal cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses to and from the study sites may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05646511

Phase III Study Comparing Short-Course Radiotherapy Plus CAPOX and CAPOXIRI Before Surgery for Locally Advanced Rectal Cancer

Led by National Cancer Center Hospital East · Updated on 2025-04-03

608

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for locally advanced rectal cancer LARC in this multicenter randomized Phase III trial. The study aims to compare two preoperative treatment approaches short-course preoperative radiation SCRT combined with CAPOXIRI versus SCRT combined with CAPOX, testing whether the triplet chemotherapy regimen CAPOXIRI is superior to the doublet regimen CAPOX following SCRT. This research builds on findings that triplet chemotherapy before chemoradiotherapy may improve patient outcomes and seeks to confirm these benefits specifically after SCRT.

CONDITIONS

Brief Title

TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Provided written informed consent after full explanation of the study
Histologically confirmed rectal adenocarcinoma
Radical surgery possible with no distant metastases on imaging
Age 18 years or older at consent
ECOG performance status 0-1 (0 if 70 years or older)
Tumor inferior margin within 12 cm of the anal verge
No prior tumor treatment
No history of pelvic radiation therapy
Clinical staging cT3-4N0M0 or T1-4N1-2M0 per UICC 8th edition with specific subcriteria
UGT1A1 gene is wild-type or single heterozygous
Adequate major organ function within 28 days prior to enrollment including neutrophils ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥9.0 g/dL, total bilirubin ≤2.0 mg/dL, AST and ALT ≤100 IU/L, and creatinine clearance ≥30 mL/min

You will not qualify if you...

Extensive surgery within 4 weeks before starting treatment (except colostomy or central venous port)
Severe lung disease history or complications such as interstitial pneumonia or pulmonary fibrosis
Presence of colonic stent
Contraindications to MRI including cardiac pacemakers
Serious comorbidities like heart failure, renal or liver failure, intestinal obstruction, uncontrolled diabetes, or active inflammatory bowel disease
Multiple active cancers within 5 years except certain curable lesions
Pregnancy, breastfeeding, positive pregnancy test, or unwillingness to use contraception
Positive hepatitis B surface antigen or hepatitis C antibody (unless HCV-RNA negative)
HIV infection
Known MSI-high or defective mismatch repair status
Unwillingness to donate specimens for gene profiling research
Any other condition deemed inappropriate by investigators

Research Team

Yoshinori Kagawa, MD., PhD

Jun Watanabe, MD., PhD

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Phase III Study Comparing Short-Course Radiotherapy Plus CAPOX and CAPOXIRI Before Surgery for Locally Advanced Rectal Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria