A Multicenter Single-arm Phase 2 Study to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy of Short Course Radiation Therapy Followed by Neoadjuvant Oxaliplatin/Fluorouracil-based Chemotherapy (CAPOX) for cT2 Rectal Cancer.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. The patient has been fully informed of the contents of the study and has given written consent.

• 2\. The patient has adenocarcinoma of the rectum confirmed by histological examination.

• 3\. No distant metastases are detected on imaging studies, and radical resection is clinically feasible.

• 4\. Age of 20 years or older on the date of consent. 5. ECOG Performance Status (PS) is 0 - 1 (PS 0 for age 71 years or older on the date of consent).

• 6\. Previously untreated rectal cancer with the lower margin of the tumor within 12 cm of the anal verge (AV).

• 7\. Patients with cT2N0M0 in the diagnosis before starting treatment (a lymph node with a short diameter of 7 mm or more is considered positive).

‣ The conditions for lymph node metastasis shall be as follows. Contrast-enhanced CT or MRI (plain or contrast-enhanced) with a slice width of 5 mm or less.

‣ (i) Short diameter of 10 mm or more (ii) Short diameter of 7 mm or more and one or more of the following a) to c) are met

‣ (a) Edge irregularity (b) Low signal area with internal heterogeneity on MRI (c) Circular (long/short diameter ratio \< 1.5) If contrast-enhanced CT is not possible due to contrast medium allergy, renal dysfunction, or bronchial asthma, simple CT is acceptable.

‣ 8\. The following criteria for major organ function within 14 days prior to registration are met.

‣ If more than one test result exists within this period, the most recent one should be used. No blood transfusions or hematopoietic factor products should be administered within 14 days prior to the test date.

⁃ Neutrophil count: greater than or equal to 1,500/mm3

⁃ Platelet count: \>= 10.0 x 104 /mm3

⁃ Hemoglobin concentration: \>=9.0 g/dL

⁃ Total bilirubin: 1.5 times or less than the upper limit of the institutional standard

⁃ AST, ALT, ALP: 2.5 times or less than the upper limit of the institutional standard

⁃ Serum creatinine: 1.5 times or less than the upper limit of the institutional standard or creatinine clearance: 45 mL/min or more

Locations
Other Locations
Japan
Osaka General Medical Center
RECRUITING
Osaka
Osaka University Hospital
RECRUITING
Osaka
Contact Information
Primary
Mamoru Uemura, MD, PhD
muemura@gesurg.med.osaka-u.ac.jp
+81-6-6879-3251
Backup
Yoshinori Kagawa, MD, PhD
yoshikagawa@gmail.com
+81-6-6692-1201
Time Frame
Start Date: 2023-05-25
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 45
Treatments
Experimental: TNT
Neoadjuvant radiation therapy : 5Gyx5 Neoadjuvant chemo therapy : CAPOX (Oxaliplatin 130mg/m2, Capecitabine2000mg/m2/day, d1-14, 3week)x6cycles Operation: Total methorectum excision wiht radical lymph node dissection
Related Therapeutic Areas
Sponsors
Leads: Osaka University

This content was sourced from clinicaltrials.gov