Evaluating total neoadjuvant therapy for 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.
This study is testing a new treatment plan that combines radiation and chemotherapy before surgery to see if it helps people with advanced rectal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Osaka University Academic / other |
| Drugs / interventions | Radiation, chemotherapy |
| Locations | 2 sites (Osaka and 1 other locations) |
| Trial ID | NCT05939661 on ClinicalTrials.gov |
What this trial studies
This multicenter, single-arm phase 2 study aims to assess the safety and efficacy of total neoadjuvant therapy, which includes short course radiation therapy followed by oxaliplatin/fluorouracil-based chemotherapy, for patients with cT2 rectal cancer. The study will involve preoperative treatment followed by surgery to determine the effectiveness of this combined approach in managing advanced rectal cancer. Participants will be monitored for safety and treatment outcomes throughout the process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 years or older with untreated adenocarcinoma of the rectum that is clinically staged as cT2N0M0.
Not a fit: Patients with distant metastases or those with a performance status greater than 1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and organ preservation for patients with rectal cancer.
How similar studies have performed: Other studies have shown promise with neoadjuvant therapies for rectal cancer, suggesting this approach may build on existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
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.
1. Neutrophil count: greater than or equal to 1,500/mm3
2. Platelet count: \>= 10.0 x 104 /mm3
3. Hemoglobin concentration: \>=9.0 g/dL
4. Total bilirubin: 1.5 times or less than the upper limit of the institutional standard
5. AST, ALT, ALP: 2.5 times or less than the upper limit of the institutional standard
6. Serum creatinine: 1.5 times or less than the upper limit of the institutional standard or creatinine clearance: 45 mL/min or more
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.
Where this trial is running
Osaka and 1 other locations
- Osaka General Medical Center — Osaka, Japan (Recruiting)
- Osaka University Hospital — Osaka, Japan (Recruiting)
Study contacts
- Study coordinator: Mamoru Uemura, MD, PhD
- Email: muemura@gesurg.med.osaka-u.ac.jp
- Phone: +81-6-6879-3251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.