Safty Study of TNT for Lower Advanced Rectal Cancer

JRCT ID: jRCTs021230062

Registered date:26/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 26/02/2024
• Target sample size: 35
• Study type: Interventional

Intervention(s)

Preoperative radiotherapy: Radiation (small pelvis 5 Gy/5 times)
Preoperative chemotherapy: 6 courses of CAPOX therapy (capecitabine 2,000 mg/m2/day, twice daily for 15 consecutive day, oxaliplatin 130 mg/m2 IV in 2 hours)

Outcome(s)

• Primary Outcome: Incidence of adverse events during preoperative treatment
• Secondary Outcome: pCR (pathologic complete response) rate, R0 resection rate/response rate, surgical complication rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Biopsy of the primary rectal lesion has been histologically diagnosed as adenocarcinoma.
2) The tumor predominantly occupies the upper rectum (Ra), lower rectum (Rb), or anal canal (P)
3) The lower border of the tumor lies between the peritoneal inversion and the anal verge
4) Tumor depth is cT3-4
5) No evidence of distant metastasis
6) Tumor is resectable
7) Patient is at least 20 years of age at the time of consent
8) ECOG performance status (PS) of 0 or 1
9) All of the following are met for the most recent laboratory values within 14 days prior to enrollment
i) Neutrophil count > 1500/mm3
ii) Total bilirubin < 1.5 mg/dl
iii) AST < 100U/L
iv) ALT < 100U/L
v) Creatinine < 1.5mg/dl
10) Written consent for participation in this study has been obtained from the patient

Exclude criteria

(Exclusions to influence efficacy evaluation)
(1)Patients with active multiple cancers
(2) Patients with infectious diseases requiring systemic treatment
(3)Patients with a fever of 38.0 degrees Celsius or higher at the time of enrollment.

(Exclusion to influence safety evaluation)
(4)Patients with allergy to 5-FU, capecitabine, or oxaliplatin
(5)Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding

(Excluded from the risk/benefit balance)
(6) Patients with psychosis or psychiatric symptoms that would make participation in the study difficult
(7) Patients with uncontrolled hypertension
(8)Patients with unstable angina (angina with onset or worsening within the last 3 weeks) or a history of myocardial infarction within 6 months
(9)Patients who are positive for HBs antigen or HCV antibody.
(10)HIV antibody-positive patients (pre-enrollment measurement of HIV antibodies is not required, but positive HIV antibodies are considered ineligible).
(11)Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema, as diagnosed by CT chest scan, or with one or more of the following complications

Translated with www.DeepL.com/Translator (free version)

Related Information

• Primary Sponsor: Shinobu Ohnuma