Rectal CancerPhase 3RCNACNCT05201430
Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer
A Phase 3 study testing FOLFOXIRI and CapeOX in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- FOLFOXIRI and CapeOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2021to Jul 2027
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRI evaluated of T3-4 or N+ rectal cancer;
- Pathologically diagnosed of rectal adenocarcinoma;
- 18 to 75 years old;
- Distance from lower margin of tumor to anus <15 cm and suitable for anus-preserving resection;
- Tumor amenable to radical resection;
- Treatment-na?ve patients with no previous systemic chemotherapy, radiotherapy or local excision for treating rectal cancer;
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- Laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count ≥ 1.5×10^9/L, Platelet count ≥ 100×10^9 /L, Hemoglobin ≥ 80 g/L, Serum bilirubin ≤ 24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60 U/L, Serum creatinine ≤ 110 umol/L;
- Be capable to receive a surgery;
- No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
- No previous systemic chemotherapy for treating colorectal cancer;
- Life expectancy of more than 3 months;
- No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1;
- Be willing and able to understand the study and to provide written informed consent.
Who cannot join
- End-stage cachexia patients;
- Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate chemotherapy or surgery;
- Metastatic carcinoma;
- Incomplete or complete intestinal obstruction;
- Known to be allergic to capecitabine, 5-Fu, oxaliplatin or irinotecan;
- Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
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- Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric historysevere infection; active disseminated intravascular coagulation; active hepatitis, severe coagulation disorder patients;
- History of other malignancy within the past 5 years except effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
- Serious organic disease including but not limited to heart, kidney, brain, and lung.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Colorectal Surgery Fudan University Shanghai Caner Center
Shanghai, Shanghai Municipality, 200032
Ye Xu, +86-21-64175590, yexu@shmu.edu.cn
About this study
Official title: Neoadjuvant FOLFOXIRI Chemotherapy Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer: An Open Label Randomized Controlled Phase III Trial
This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- FOLFOXIRI, CapeOX
- Keywords
- Neoadjuvant chemotherapy, Locally advanced rectal cancer, FOLFOXIRI, CapeOX
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRIDrug
Also called 5-Fu, Oxaliplatin, Irinotecan, Surgery
irinotecan* 165 mg/m² iv continue for 1.5 hours, D1 oxaliplatin 85 mg/m² iv continue for 2 hours, D1 leucovorin 400 mg/m² iv continue for 2 hours, D1 5-FU 2400~3200 mg/m² cont. inf. 48h, D1 repeat every 2 weeks (Q2W)
CapeOXDrug
Also called Capecitabine, Oxaliplatin, Surgery
oxaliplatin 130 mg/m2 iv continue for 2 hours, D1 capecitabine 1000mg/m2/d PO Bid, once every morning and evening D1-14 repeat every 3 weeks (Q3W)
| Study group | Role | What they receive |
|---|---|---|
| A: FOLFOXIRI | Experimental | Neoadjuvant chemotherapy with 3-4 cycles of FOLFOXIRI regimen, followed by surgery Receives: Drug: FOLFOXIRI |
| B: CapeOX | Experimental | Neoadjuvant chemotherapy with 2-3 cycles of CapeOX regimen, followed by surgery Receives: Drug: CapeOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival
Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first. Compare 3-year disease free survival in patients with locally advanced rectal cancer treated with either FOLFOXIRI or CapeOX neoadjuvant chemotherapy.
Measured: 3 years
Secondary outcomes (8)
pathologic complete response rate
Defined as the ratio of patients with pathologic TRG 0
Measured: 1 year
major pathologic response rate
Defined as the ratio of patients with pathologic TRG 0 or 1
Measured: 1 year
objective response rate
Defined as the ratio of patients with MRI-TRG 1, 2 or 3
Measured: 1 year
local recurrence rate
Defined as the ratio of patients with local recurrence within 3 years.
Measured: 3 years
overall survival
Defined as the length of time from randomization date until the date of death from any cause.
Measured: 5 years
quality of life as assessed by EORTC QOL-C30
Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-C30 version 3
Measured: 3 years
quality of life as assessed by EORTC QOL-CR29
Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-CR29.
Measured: 3 years
adverse event
Number of patients with adverse events and severity according to NCI CTC 5.0 after neoadjuvant chemotherapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start27 Aug 2021
- Primary completionJun 2024 (estimated)
- Study completionJul 2027 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Xu, Fudan University
- Investigators
- Ye Xu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201430
- Sponsor's protocol ID
- 2108240-5
- Acronym
- RCNAC
- Status last verified
- Feb 2022
- First submitted
- 4 Dec 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Proper legal IPD will be shared when publishing articles.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant FOLFOXIRI Chemotherapy Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer: An Open Label Randomized Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT05201430
- Acronym / sponsor ID
- RCNAC / 2108240-5
- Conditions
- Rectal Cancer
- Keywords
- Neoadjuvant chemotherapy, Locally advanced rectal cancer, FOLFOXIRI, CapeOX
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Jan 2022 (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.
This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: FOLFOXIRI | Experimental | Drug: FOLFOXIRINeoadjuvant chemotherapy with 3-4 cycles of FOLFOXIRI regimen, followed by surgery |
| B: CapeOX | Experimental | Drug: CapeOXNeoadjuvant chemotherapy with 2-3 cycles of CapeOX regimen, followed by surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- MRI evaluated of T3-4 or N+ rectal cancer;
- Pathologically diagnosed of rectal adenocarcinoma;
- 18 to 75 years old;
- Distance from lower margin of tumor to anus <15 cm and suitable for anus-preserving resection;
- Tumor amenable to radical resection;
Key exclusion criteria (9 listed)
- End-stage cachexia patients;
- Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate chemotherapy or surgery;
- Metastatic carcinoma;
- Incomplete or complete intestinal obstruction;
- Known to be allergic to capecitabine, 5-Fu, oxaliplatin or irinotecan;
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 |
|---|---|---|
| FOLFOXIRIAlso: 5-Fu, Oxaliplatin, Irinotecan, Surgeryirinotecan* 165 mg/m² iv continue for 1.5 hours, D1 oxaliplatin 85 mg/m² iv continue for 2 hours, D1 leucovorin 400 mg/m² iv continue for 2 hours, D1 5-FU 2400~3200 mg/m² cont. inf. 48h, D1 repeat every 2 weeks (Q2W) | Drug | A: FOLFOXIRI |
| CapeOXAlso: Capecitabine, Oxaliplatin, Surgeryoxaliplatin 130 mg/m2 iv continue for 2 hours, D1 capecitabine 1000mg/m2/d PO Bid, once every morning and evening D1-14 repeat every 3 weeks (Q3W) | Drug | B: CapeOX |
Primary outcome
3-year disease free survival
Time frame: 3 years
Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first. Compare 3-year disease free survival in patients with locally advanced rectal cancer treated with either FOLFOXIRI or CapeOX neoadjuvant chemotherapy.
8 secondary outcomes
pathologic complete response rate
Time frame: 1 year
major pathologic response rate
Time frame: 1 year
objective response rate
Time frame: 1 year
local recurrence rate
Time frame: 3 years
overall survival
Time frame: 5 years
quality of life as assessed by EORTC QOL-C30
Time frame: 3 years
quality of life as assessed by EORTC QOL-CR29
Time frame: 3 years
adverse event
Time frame: 1 year
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 4 Mar 2022.
- Individual participant dataSharing planned: Undecided. Proper legal IPD will be shared when publishing articles.
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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.
Ye Xu principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOLFOXIRI and CapeOX in people with Rectal Cancer, run by Fudan University at 1 site in China.
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 14 inclusion and 9 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Tianan Guo (+86-021-64035387, 11307120071@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival (time frame: 3 years). 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 4 Mar 2022.