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A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer

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.

NCT05939661•Osaka University

View on ClinicalTrials.gov

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

Detailed Description

To evaluate the efficacy and safety of preoperative radiation therapy followed by preoperative chemotherapy and surgery for T2 advanced rectal cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+7 more criteria

Exclusion Criteria

•1\. underwent treatment by any of the following within a certain period of time prior to initiation of protocol therapy
•1. extensive surgery (excluding CV port placement) within 4 weeks
•2. Any anticancer therapy within 4 weeks
•3. Radiation within 4 weeks 2. concomitant or pre-existing severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.) 3. patients who have had a colonic stent implanted 4. patients with serious comorbidities (heart failure, renal failure, liver failure, bleeding peptic ulcer, intestinal paralysis, bowel obstruction, poorly controlled diabetes, etc.) 5. patients with active multiple overlapping cancers (synchronous multiple overlapping cancers or iatrogenic multiple overlapping cancers with a disease-free period of 5 years or less). However, carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma that is considered curable by local treatment is not considered active multiple overlapping carcinoma.
•6\. pregnant or lactating women, positive pregnancy test or unwillingness to use contraception 7. HBs antigen positive or HCV antibody positive. 8. has known human immunodeficiency virus (HIV) infection. 9. otherwise judged by the principal investigator or subinvestigator to be unsuitable for this study.

Locations (2)

Osaka General Medical Center

Osaka, Japan

Osaka University Hospital

Osaka, Japan

Key Dates

Start Date

May 25, 2023

Primary Completion Date

March 31, 2026

Completion Date

March 31, 2030

Last Updated

July 11, 2023

Enrollment

ESTIMATED participants

Conditions

Rectal Cancer

Interventions

Radiation

RADIATION

Chemotherapy

DRUG

Surgery

PROCEDURE

Contacts

Mamoru Uemura, MD, PhD

CONTACT

+81-6-6879-3251 muemura@gesurg.med.osaka-u.ac.jp

Yoshinori Kagawa, MD, PhD

CONTACT

+81-6-6692-1201 yoshikagawa@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer

Inclusion Criteria

Exclusion Criteria

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