Rectal CancerPhase 2AMBITIONNCT05939661
A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer
A Phase 2 study testing Radiation, Chemotherapy and Surgery in people with Rectal Cancer, run by Osaka University at 2 sites in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Radiation, Chemotherapy and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesJapan
- Study dates
- 25 May 2023to 31 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
- 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
- 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
Who cannot join
- 1. 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.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites, 2 recruiting
- Recruiting
Osaka General Medical Center
Osaka
Yoshinori Kagawa, yoshikagawa@gmail.com
- Recruiting
Osaka University Hospital
Osaka
Mamoru Uemura, muemura@gesurg.med.osaka-u.ac.jp
About this study
Official title: 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.
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
Read the detailed description
To evaluate the efficacy and safety of preoperative radiation therapy followed by preoperative chemotherapy and surgery for T2 advanced rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Radiation, Chemotherapy, Surgery
- Keywords
- total neoadjuvant therapy, neadjuvant chemotherapy, organ preservation, watch and wait, radiation, surgery, total mesorectum excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Neoadjuvant radiation therapy : 5Gyx5
ChemotherapyDrug
CAPOX (Oxaliplatin 130mg/m2, Capecitabine2000mg/m2/day, d1-14, 3week)x6cycles
SurgeryProcedure or surgery
Operation: Total methorectum excision wiht radical lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| TNT | Experimental | 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 Receives: Radiation: Radiation; Drug: Chemotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR)
pCR is evaluated by using the grading scale according to the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start25 May 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- RT→Chemo→Surgery
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mamoru Uemura, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939661
- Sponsor's protocol ID
- jRCTs051230014
- Acronym
- AMBITION
- Status last verified
- Jul 2023
- First submitted
- 25 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05939661
- Acronym / sponsor ID
- AMBITION / jRCTs051230014
- Conditions
- Rectal Cancer
- Keywords
- total neoadjuvant therapy, neadjuvant chemotherapy, organ preservation, watch and wait, radiation, surgery, total mesorectum excision
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RT→Chemo→Surgery
| Arm | Type | Receives |
|---|---|---|
| TNT | Experimental | Radiation: Radiation, Drug: Chemotherapy, Procedure: SurgeryNeoadjuvant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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).
Key exclusion criteria (5 listed)
- 1. underwent treatment by any of the following within a certain period of time prior to initiation of protocol therapy
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationNeoadjuvant radiation therapy : 5Gyx5 | Radiation | TNT |
| ChemotherapyCAPOX (Oxaliplatin 130mg/m2, Capecitabine2000mg/m2/day, d1-14, 3week)x6cycles | Drug | TNT |
| SurgeryOperation: Total methorectum excision wiht radical lymph node dissection | Procedure or surgery | TNT |
Primary outcome
Pathological complete response (pCR)
Time frame: through study completion, an average of 6 months
pCR is evaluated by using the grading scale according to the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation, Chemotherapy and Surgery in people with Rectal Cancer, run by Osaka University at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mamoru Uemura, MD, PhD (+81-6-6879-3251, muemura@gesurg.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.