Clinical trial of total neoadjuvant therapy for lower advanced rectal cancer

Phase 2

Recruiting

• Conditions: lower advanced rectal cancer; rectal cancer

• Registration Number: JPRN-jRCTs031210660
• Lead Sponsor: Ishihara Soichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Those who meet all of the following selection criteria are targeted.
1) The below rectum tumor or even if the above rectal tumor reaches the below rectum
2) Cases confirmed to be adenocarcinoma histologically
3) Cases judged to fall under any of the following by preoperative diagnosis using MRI or CT
(1) Cases of infiltration into surrounding organs (T4b, anyN)
(2) Cases with suspected advanced lymph node metastasis such as lateral lymph node metastasis
(3) Cases diagnosed with suspicion of Extramural Venous Invasion (EMVI)
4) Cases without distant organ metastasis
5) Cases of age 20 to 80 years (at the time of obtaining consent)
6) Cases in which radiation therapy, chemotherapy, or hormone therapy is not performed as pretreatment
7) Cases in which food can be ingested and drugs can be orally administered
8) Cases in which the functions of major organs (bone marrow, heart, lungs, liver, kidneys, etc.) are sufficiently maintained: The doctor makes a judgment based on the following values.
a. White blood cell count: 4,000 / mm3 and more, and 12,000 / mm3 and less
b. Number of neutrophils: 2,000 / mm3 or more
c. Platelet count: 100,000 / mm3 or more
d. Hemoglobin: 9.0 g / dl or higher
e. Total bilirubin: 1.5 mg / dl or less
f. AST (GOT) / ALT (GPT): 100 IU / L and less
g. Serum creatinine clearance: 60.0 mL / min and more *
* If the creatinine clearance by 24-hour urine collection is actually measured, use that value.
If there is no measured value, calculate the estimated value using the following Cockcroft-Gault estimation formula
Male: creatinine clearance = body weight x (140-age) / (72 x serum creatinine level)
Female: creatinine clearance = 0.85 x {weight x (140-age) / (72 x serum creatinine level)}
9) Cases with no abnormal findings on the electrocardiogram (abnormalities without clinical problems are acceptable)
10) Cases with a general performance status (P.S.) of 0 to 1
11) Cases without sensory neuropathy
12) Cases in which the research subject has given written consent to participate in the study

Exclusion Criteria

Those who meet any of the following exclusion criteria will be excluded from the target.
1) Cases with a history of drug hypersensitivity
2) Cases where UFT / UZEL is contraindicated
3) Cases where administration of CPT-11 is contraindicated
4) Cases of UGT1A1 *6/*6, UGT1A1 *28/*28 and heterozygotes (UGT1A1*6/*28)
5) Cases where 5-FU administration is contraindicated
6) Cases where administration of LV is contraindicated
7) Cases where L-OHP administration is contraindicated
8) Cases where administration of Capecitabine is contraindicated
9) Cases receiving flucytosine, phenytoin, and potassium warfarin
10) Cases with active infectious diseases (fever 38.0 degree or higher)
11) Cases with serious complications (intestinal palsy, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poor control or severe diabetes, heart failure, renal failure, liver failure, autoimmune disease, etc.)
12) Cases with diarrhea (more than 4 times a day or watery stool)
13) Patients with clinical brain metastases and cases with a history of brain metastases
14) Cases with simultaneous double cancer or metachronous double cancer with a disease-free period of 5 years or less
15) Pregnant or lactating women, or with the potential (will) to become pregnant
16) Men who wish to have children
17) Other cases that the doctor in charge deems inappropriate as a target

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of adverse events at the end of postoperative adjuvant therapy FOLFOX therapy or CAPOX therapy

Secondary Outcome Measures

Name	Time	Method
(1) Therapeutic effect<br>a. down-staging rate<br>b. pCR rate<br>c. Dose intensity<br>d. Treatment completion rate<br>(2) Prognosis<br>a. Perioperative safety (incidence of adverse events occurring by 30 days after surgery)<br>b. Local recurrence rate<br>c. Distant metastasis recurrence rate<br>d. Recurrence-free survival<br>e. Overall survival