A Multi-center Phase II Clinical Trial to Investigate the Safety and Efficacy of Preoperative Short-Term Radiotherapy and Chemotherapy for Locally Advanced Rectal Cancer

JRCT ID: jRCTs051220171

Registered date:15/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 02/03/2023
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Preoperative short radiotherapy+chemotherapy+surgery+-adjuvant chemotherapy

Outcome(s)

• Primary Outcome: Pathological complete response rate

Secondary Outcome

Efficacy outcome: Overall survival, recurrence-free survival, R0 resection rate, histological response rate
Safety outcome: rate of preoperative treatment-related disease, rate of protocol treatment completion, rate of preoperative radiotherapy completion, rate of preoperative chemotherapy completion, rate of intraoperative complications, rate of postoperative complication

Key inclusion & exclusion criteria

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

Include criteria

1) Histologically proven adenocarcinoma of the rectum
2) Lower margin of tumor within 12 cm from anal verge (AV)
3) cT2N1~3M0 or cT3~4bNanyM0 by diagnostic imaging
4) The presence or absence of clinical metastasis of the lateral pelvic lymph nodes is irrelevant.
5) Negative for clinical inguinal lymph node metastasis.
6) Age at the time of registration is over 20 years old.
7) Performance Status (PS) is 0 or 1.
8) Major organ function is preserved by clinical examination within 14 days before registration (examination on the same day of the week 2 weeks before the registration date is acceptable) (examination to determine whether the patient is eligible for this study may adopt the results of tests performed before obtaining informed consent as general tests for cancer treatment).
1. Neutrophil count >=1,500/mm3
2. Platelet count >=100,000 /mm3
3. Hemoglobin >=8.0 g/dL
4. AST, ALT <=100 IU/L
5. Total bilirubin <=1.5 mg/dL
6. Serum creatinine <=1.5 mg/dL
9) Patients who have given their voluntary written consent to participate in this clinical study

Exclude criteria

(1) Have received anticancer drug therapy, radiation therapy, hormone therapy, or immunotherapy within 4 weeks before registration
(2) Have allergy to drugs used in this study
(3) Have an active infection which requires systemic treatment
(4) Serious comorbidities (heart failure, ischemic heart disease, renal failure, liver failure, bleeding peptic ulcer, intestinal paralysis, intestinal obstruction, poorly controlled diabetes mellitus, severe paresthesia or paresthesia with functional impairment,etc.).
(5) Severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).
(6) History of clinically relevant psychiatric disorder or central nervous system disorder.
(7) Gastrointestinal perforation, active gastrointestinal ulcer, CTCAE (ver5.0) Grade 3 or higher bleeding (site not specified).
(8) Active double cancer. (Synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years or less, carcinoma in situ or lesions equivalent to intramucosal carcinoma judged to be cured by local treatment are excluded from this criteria.)
(9) HBs antigen positive or HCV antibody positive.
(10) Pregnant women, breastfeeding women, or women who may be pregnant
(11) Patients who are judged inappropriate for participation in this clinical study by the principal investigator or investigator.

Related Information

• Primary Sponsor: Matsuda Takeru
• Secondary Sponsor: Kakeji Yoshihiro