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

ConditionLocally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Center Hospital East

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SCRT

    Radiation

    5x5 Gy: 25 Gy

  • CAPOX

    Drug

    Six cycles of CAPOX capecitabine 1000 mg/m2 orally twice daily on days 1-14, oxaliplatin 130 mg/m2 intravenously on day 1, every 3 weeks

  • CAPOXIRI

    Drug

    Six cycles of CAPOXIRI capecitabine 800 mg/m2 orally twice daily on days 1-14, oxaliplatin 130 mg/m2 intravenously on day 1 and irinotecan 150 mg/m2 intravenously on day 1, every 3 weeks

Treatment groups

608 Participants
are divided into 2 treatment groups
Group A: Control arm SCRT+CAPOXActive comparator 2 interventions
Group B: Experimental arm SCRT+CAPOXIRIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Organ-preservation adapted DFS

The investigators use the definition of organ-preservation adopted DFS proposed in the international consensus statement for preoperative treatment (75). It is defined as the period from the date of allocation to the earliest of the following events. 1. Surgery difficult due to local progression or study subject unfit for surgery 2. R2 resection of primary tumor ( not including Circumferential resection margin (CRM) positive ) 3. Local recurrence after R0/1 resection of primary tumor 4. Local regrowth for which Salvage surgery is not possible during NOM 5. Appearance of distant metastases 6. Occurrence of second primary colorectal cancer 7. Development of second primary other cancers 8. Death (treatment-related death, death from the same cancer, death from a different type of cancer, non-cancer-related death)

Time frame
Up to 3 years. It is defined as the period from the allocation date to the earliest of the following events.

Secondary outcomes

1

cCR rate

The investigators will use the Memorial Sloan Kettering Regression Schema, which is the cCR standard for TNT clinical trials conducted mainly in the United States. For judgment, a gastrointestinal endoscopist, a pathological diagnostician, and a gastrointestinal surgeon discuss and comprehensively judge.

Time frame
1-3 weeks (Days 7-21) from the completion of preoperative chemotherapy or the date of discontinuation.
2

Clinical response (cCR+near CR [nCR]) rate

The investigators will use the Memorial Sloan Kettering Regression Schema, which is the cCR standard for TNT clinical trials conducted mainly in the United States. For judgment, a gastrointestinal endoscopist, a pathological diagnostician, and a gastrointestinal surgeon discuss and comprehensively judge.

Time frame
Within 1-3 weeks (Days 7-21) from the completion of preoperative chemotherapy or the date of discontinuation.
3

Proportion of NOM selection

The proportion of the number of research subjects for whom NOM was selected at the time of re-evaluation to the analysis population as the numerator. Study subjects who died of any cause before the re-evaluation decision date will be treated as "no complete resection" and included in the denominator but not the numerator.

Time frame
3-6 weeks (Days 21-42) from the completion of preoperative chemotherapy or the date of discontinuation.
4

Recurrence type and recurrence rate

The recurrence site is classified into local recurrence, distant recurrence, and unknown, and is defined as "recurrence type". Select multiple categories if recurrence is observed at multiple sites at the time of the first recurrence.

Time frame
3 years (up to 5 years)

Other outcomes

1

liquid biopsy

Analysis using liquid biopsy will be performed to identify biomarkers that predict therapeutic effects by performing blood genome profiling.

Time frame
3 years (up to 5 years)
2

Artificial Intelligence (AI) (deep learning) analysis

Using multiple algorithms, in addition to colonoscopy and pelvic MRI images at each point, clinicopathological features, various biomarkers, and QOL will be utilized to estimate the optimal treatment method for individual research subjects

Time frame
3 years (up to 5 years)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Center Hospital East

Lead sponsor

Japan Agency for Medical Research and Development

Collaborator

Source ClinicalTrials.gov
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