TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer
NCT ID: NCT05646511
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
608 participants
INTERVENTIONAL
2022-11-21
2030-12-31
Brief Summary
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Detailed Description
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Pts in both groups will be re-staged after completing TNT before radical surgery according to the Memorial Sloan Kettering Regression Schema; pts with incomplete response (iCR) will undergo total mesorectal excision (TME), cCR pts will receive NOM, and nCR pts will undergo TME or NOM by a physician discretion under the recommendation of blind assessment by the designated NOM central committee. Pts will be followed by CT, MRI, colonoscopy and liquid biopsy every 4 months for 2 years, and every 6 months thereafter up to 5 years.
To detect a decrease in 3-year cumulative probability of organ preservation-adapted Disease free survival (DFS) from 75.0% to 81.7%, corresponding to a target hazard ratio of 0·70, a total of 608 pts (196 events) would achieve 70% power at a two-sided α significance level of 0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control arm SCRT+CAPOX
The standard-of-care group receives short-course radiation therapy (5 × 5 Gy) followed by six cycles of CAPOX (capecitabine 1000 mg/m2 orally twice daily on days 1-14, oxaliplatin 130 mg/m2 intravenously on day 1, q3wks).
SCRT
5x5 Gy: 25 Gy
CAPOX
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
Experimental arm SCRT+CAPOXIRI
The standard-of-care group receives short-course radiation therapy (5 × 5 Gy) followed by 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\*, q3wks).
SCRT
5x5 Gy: 25 Gy
CAPOXIRI
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
Interventions
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SCRT
5x5 Gy: 25 Gy
CAPOX
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed rectal adenocarcinoma.
3. Radical resection is clinically possible without any distant metastases on imaging studies.
4. Age of 18 years or older on the date of consent acquisition.
5. Eastern Cooperative Oncology Group (ECOG) PS 0-1 (PS 0 if aged 70 years or older on consent acquisition date).
6. Inferior margin of the tumor is within 12 cm of the AV.
7. No prior tumor treatment.
8. No history of radiation therapy to the pelvis, including treatment for other cancer types.
9. 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 ≤ 12 cm, T3a/bN0-1M0, EMVI-, MRF clear are eligible only for those who refused surgery)
10. UGT1A1 is wild-type or single heterozygous.
11. 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 will not be administered within 14 days before the test date for measurements before registration.
1. Neutrophil count: ≥1,500/mm3
2. Platelet count: ≥10.0×10 4/mm3
3. Hemoglobin concentration: ≥9.0 g/dL
4. Total bilirubin: ≤2.0 mg/dL
5. Aspartate transaminase (AST): ≤100 IU/L or less
6. Alanine transaminase (ALT): ≤100 IU/L or less
7. Serum creatinine: Creatinine clearance ≥30 mL/min (by Cockcroft \& Gault formula)
Exclusion Criteria
2. Complications or history of severe lung disease (such as interstitial pneumonia, pulmonary fibrosis, and severe emphysema).
3. Colonic stent in place.
4. Contraindications for MRI such as cardiac pacemakers.
5. Serious comorbidities (such as heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, and active inflammatory bowel disease).
6. 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 carcinoma, which can be cured by local treatment, are not treated as active multiple cancers.
7. Pregnant women, lactating women, positive pregnancy test, or unwillingness to use contraception.
8. Hepatitis B surface (HBs) antigen positive or hepatitis C virus (HCV) antibody-positive. However, HCV-RNA-negative can be registered.
9. Have human immunodeficiency virus (HIV) infection.
10. MSI-high (MSI-H) or defective mismatch repair (dMMR) is known.
11. 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." (CONDUCTOR study).
12. Any other patients the principal investigator or co-investigator deems inappropriate for study participation.
18 Years
ALL
No
Sponsors
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Japan Agency for Medical Research and Development
OTHER_GOV
National Cancer Center Hospital East
OTHER
Responsible Party
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Takayuki Yoshino
MD., PhD Head of Department of Gastroenterology and Gastrointestinal Oncology
Locations
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National Cancer Center Hospital East
Chiba, , Japan
Ehime Prefectural Central Hospital
Ehime, , Japan
Kyushu University Hospital
Fukuoka, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Gifu University Hospital
Gifu, , Japan
Hirosaki University Hospital
Hirosaki, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
St. Marianna University Hospital
Kawasaki, , Japan
University of Occupational and Environmental Health Hospital
Kitakyushu, , Japan
Kochi Medical School Hospital
Kochi, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Kyoto Prefectural University of Medicine
Kyoto, , Japan
Nagoya University Hospital
Nagoya, , Japan
Ohara Memorial Kurashiki Central Medical Organization Kurashiki Central Hospital
Okayama, , Japan
Okayama University Hospital
Okayama, , Japan
Kansai Medical University Hospital
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
National Hospital Organization Osaka Medical Center
Osaka, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Osaka Prefectural Hospital Organization Osaka Acute and General Medical Center
Osaka, , Japan
Osaka University Hospital
Osaka, , Japan
Kitasato University Hospital
Sagamihara, , Japan
Sapporo Medical University Hospital
Sapporo, , Japan
Keio University Hospital
Tokyo, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Komagome Hospital
Tokyo, , Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, , Japan
Yokohama City University Hospital
Yokohama, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
Federation of National Public Service Personnel Mutual Aid Associations Yokosuka Mutual Aid Hospital
Yokosuka, , Japan
Countries
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Central Contacts
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Facility Contacts
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Takayuki Yoshino, Dr.
Role: primary
Masanori Hotchi, Dr.
Role: primary
Eiji Oki, Dr.
Role: primary
Masahiko Sugiyama, Dr.
Role: primary
Tetsuya Kusumoto, Dr.
Role: primary
Nobuhisa Matsuhashi, Dr.
Role: primary
Takuya Miura, Dr.
Role: primary
Hideki Ohdan, Dr.
Role: primary
Naoki Izawa, Dr.
Role: primary
Keiji Hirata, Dr.
Role: primary
Hironaga Satake, Dr.
Role: primary
Yuji Miyamoto, Dr.
Role: primary
Goro Nakayama, Dr.
Role: primary
Mitsuru Yokota, Dr.
Role: primary
Toshiyoshi Fujiwara, Dr.
Role: primary
Jun Watanabe, Dr.
Role: primary
Junichiro Kawamura, Dr.
Role: primary
Takeshi Kato, Dr.
Role: primary
Yoshinori Kagawa, Dr.
Role: primary
Yujiro Nishizawa, Dr.
Role: primary
Mamoru Uemura, Dr.
Role: primary
Takeshi Naito, Dr.
Role: primary
Koichi Okuya, Dr.
Role: primary
Koji Okabayashi, Dr.
Role: primary
Yukihide Kanemitsu, Dr.
Role: primary
Takeshi Yamada, Dr.
Role: primary
Yuichi Nagakawa, Dr.
Role: primary
Kazushige Kawai, Dr.
Role: primary
Manabu Shiozawa, Dr.
Role: primary
Mayumi Ozawa, Dr.
Role: primary
Yusuke Suwa, Dr.
Role: primary
Hirokazu Suwa, Dr.
Role: primary
References
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Watanabe J, Kagawa Y, Chida K, Ando K, Kotani D, Oba K, Bando H, Hojo H, Shimamoto S, Sakashita S et al: Phase III trial of short-course radiotherapy followed by CAPOXIRI versus CAPOX in locally advanced rectal cancer: the ENSEMBLE trial. ESMO Gastrointestinal Oncology 2023, 1:9-14.
Kagawa Y, Smith JJ, Fokas E, Watanabe J, Cercek A, Greten FR, Bando H, Shi Q, Garcia-Aguilar J, Romesser PB, Horvat N, Sanoff H, Hall W, Kato T, Rodel C, Dasari A, Yoshino T. Future direction of total neoadjuvant therapy for locally advanced rectal cancer. Nat Rev Gastroenterol Hepatol. 2024 Jun;21(6):444-455. doi: 10.1038/s41575-024-00900-9. Epub 2024 Mar 14.
Scott AJ, Kennedy EB, Berlin J, Brown G, Chalabi M, Cho MT, Cusnir M, Dorth J, George M, Kachnic LA, Kennecke HF, Loree JM, Morris VK, Perez RO, Smith JJ, Strickland MR, Gholami S. Management of Locally Advanced Rectal Cancer: ASCO Guideline. J Clin Oncol. 2024 Oct;42(28):3355-3375. doi: 10.1200/JCO.24.01160. Epub 2024 Aug 8.
Kagawa Y, Watanabe J, Uemura M, Ando K, Inoue A, Oba K, Takemasa I, Oki E. Short-term outcomes of a prospective multicenter phase II trial of total neoadjuvant therapy for locally advanced rectal cancer in Japan (ENSEMBLE-1). Ann Gastroenterol Surg. 2023 Jul 11;7(6):968-976. doi: 10.1002/ags3.12715. eCollection 2023 Nov.
Kagawa Y, Ando K, Uemura M, Watanabe J, Oba K, Emi Y, Matsuhashi N, Izawa N, Muto O, Kinjo T, Takemasa I, Oki E. Phase II study of long-course chemoradiotherapy followed by consolidation chemotherapy as total neoadjuvant therapy in locally advanced rectal cancer in Japan: ENSEMBLE-2. Ann Gastroenterol Surg. 2024 Aug 3;8(6):1067-1075. doi: 10.1002/ags3.12848. eCollection 2024 Nov.
Other Identifiers
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jRCTs031220342
Identifier Type: REGISTRY
Identifier Source: secondary_id
K2022001
Identifier Type: -
Identifier Source: org_study_id
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