A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer
AMBITION
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.
1 other identifier
interventional
45
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2023
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2023
CompletedFirst Submitted
Initial submission to the registry
June 25, 2023
CompletedFirst Posted
Study publicly available on registry
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2030
ExpectedJuly 11, 2023
July 1, 2023
2.9 years
June 25, 2023
July 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological complete response (pCR)
pCR is evaluated by using the grading scale according to the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma
through study completion, an average of 6 months
Study Arms (1)
TNT
EXPERIMENTALNeoadjuvant 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
Interventions
Eligibility Criteria
You may qualify if:
- \. The patient has been fully informed of the contents of the study and has given written consent.
- \. The patient has adenocarcinoma of the rectum confirmed by histological examination.
- \. No distant metastases are detected on imaging studies, and radical resection is clinically feasible.
- \. 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).
- \. Previously untreated rectal cancer with the lower margin of the tumor within 12 cm of the anal verge (AV).
- \. 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.
- \. 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
- +2 more criteria
You may not qualify if:
- \. underwent treatment by any of the following within a certain period of time prior to initiation of protocol therapy
- extensive surgery (excluding CV port placement) within 4 weeks
- Any anticancer therapy within 4 weeks
- 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.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Osaka Universitylead
Study Sites (2)
Osaka General Medical Center
Osaka, Japan
Osaka University Hospital
Osaka, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Study Record Dates
First Submitted
June 25, 2023
First Posted
July 11, 2023
Study Start
May 25, 2023
Primary Completion
March 31, 2026
Study Completion (Estimated)
March 31, 2030
Last Updated
July 11, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share