Phase I/II trial of neoadjuvant chemotherapy with UFT/Leucovorin and Irinotecan plus radiation in patients with locally advanced rectal cancer.

Phase I/II trial of neoadjuvant chemotherapy with UFT/Leucovorin and Irinotecan plus radiation in patients with locally advanced rectal cancer. - Phase I/II trial of neoadjuvant chemotherapy with UFT/Leucovorin and Irinotecan plus radiation in patients with locally advanced rectal cancer.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006208

Enrollment

Registered

2011-08-22

Start date

2011-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced rectal cancer with preoperative diagnosis of T3-4 and N0-3.

Interventions

Radiotherapy with two parallel opposed lateral fields will be administered in fractions of 1.8 Gy/day, given 5 days per week for 28days. The total dose of radiation will be 50.4 Gy.. UFT (300 mg/m2/

#8211

5, 8&amp

12, 22&amp

26, and 29&amp

33. Irinotecan will be given as a continuous i.v. infusion for 90 min on Days 1, 15, 29, and 43. The initial dose of Irinotecan was 50 mg/m2 (Level 1), given to 3 patients. The dose will be increased

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Previously untreated locally advanced lower rectal cancer with preoperative diagnosis of T3/4 and N0-3 and M0. 2. Histopathologically confirmed as adenocarcinoma before surgery. 3. No disturbance of main organ functions ( including bone marrow, heart, lung, liver and kidney) 3-1. Leukocyte count.: >=4,000/mm3 and <=12,000/mm3 3-2. Neutrophil count.: >=2,000/mm3 3-3. Platelet count.: >=100,000/mm3 3-4. Hemoglobin concentration.: >=9.0 g/dl. 3-5. Total bilirubin concentration.: <=1.5 mg/dl 3-6. Serum AST(GOT) and ALT(GPT) .: less than twice the upper limit of the normal at our hospital. 3-7. Serum creatinine concentration. less than upper limit of the normal at our hospital 4. Ability to ingestion intake and drug administration orally. 5. Performance status (ECOG): 0-1 6. Informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1. Allergic to a drug 2. Contraindications to UFT, Leucovorin and Irinotecan 3. Active infection 4. UGT1A: *6/*6, *28/*28 and *6/*28 5. Severe complications such as ileus, interstitial pneumonia, DM, heart failure, lung failure and liver failure 6. Pregnant or planning to get pregnant.

Design outcomes

Primary

Measure	Time frame
MTD and RD are determined by step 1. Histopathological effects are primary endpoints of step 2.	—

Secondary

Measure	Time frame
Ratio of downstaging, rate of local recurrence, disease free survival and occurrence of adverse events are secondary outcomes of step 2.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026