Rectal CancerPhase 2NCT02942563
Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
A Phase 2 study testing FOLFOXIRI in people with Rectal Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them even more severer. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2016to 30 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 to 75 years at diagnosis
- Diagnosis of rectal adenocarcinoma
- ECOG status: 0～1
- Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
- Leukocytes ≥ 4.0 x109/ L,
Show all 14Show fewer
- Absolute neutrophil count (ANC) ≥ 2.0 x109/ L
- Platelet count ≥ 100 x109/ L,
- Hemoglobin (Hb) ≥ 9g/ dL.
- Total bilirubin ≤1.5 x the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) ≤ 3 x ULN
- Aspartate aminotransferase (AST) ≤ 3 x ULN.
- Serum creatinine ≤ 1.5 x the ULN.
- Signed informed consent;
Who cannot join
- Patient had received pelvic radiotherapy
- Patient had received systemic chemotherapy
- Pregnant and Nursing women
- Had metastatic disease
- Uncontrolled co-morbid illnesses or other concurrent disease
- Patient had second malignant disease within 5 years
- Patients refused to signed informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Ming Ye, Master, +862168383459, renjiyeming@163.com
Qi Lu, Master, +862158752345 ext. 33364, luqi@renji.com
About this study
Official title: A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them even more severer. A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological complete response (pCR), which was associated with overall survival (OS). Here, the investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent chemoradiation and to improve the ratio of pCR further.
Read the detailed description
This is a multicenter, phase II trial to assess the efficacy/safety of triplet regimen (FOLFOXIRI) for patients with LARC. After 4 cycles of FOLFOXIRI and 2 weeks later, the patients will be evaluated by senior radiologist, oncologist and surgeon through pelvic MRI, CT and Positron Emission Computed Tomography (PET-CT). The patients will go to surgery (TME) if the tumor response is good enough to have complete resection under the decision of MDT,otherwise, the patients will receive pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625mg/M^2, bid po, d1-5, qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m² bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME. All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.
- Conditions
- Rectal Cancer
- Being tested
- FOLFOXIRI
- Keywords
- Local Advanced Rectal Cancer, Total Neoadjuvant Therapy, FOLFOXIRI
- 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 Irinotecan, Oxaliplatin, 5-FU, Capecitabine
Irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle for 4-6 cycles,
Chemoradiation for patients who are not suitable to surgery:
Pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625mg/m², bid po, d1-5, qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m² bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME.
All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI | Experimental | irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle Receives: Drug: FOLFOXIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic complete resection rate
Pathologic confirmation
Measured: Up to 10 weeks
Secondary outcomes (7)
The rate of local control
Imaging diagnosis
Measured: 3 years
Disease free survival (DFS)
Imaging diagnosis
Measured: 3 years
Overall survival
Record document
Measured: 3 years
The rate of receive chemoradiation
Record document
Measured: Up to 10 weeks
The rate of clinical complete response after 4 cycles of FOLFOXIRI
Imaging diagnosis
Measured: Up to 10 weeks
The rate of pathological complete response after 4 cycles of FOLFOXIRI
Pathologic confirmation
Measured: Up to 10 weeks
The incidence of >=3 grade adverse events
Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start1 Nov 2016
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2022 (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 RenJi HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Ye, Master, Principal investigator, Locations: China, Shanghai Shanghai Jiaotong University School of Medicine, Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942563
- Sponsor's protocol ID
- 2016CRC R-001
- Status last verified
- Dec 2017
- First submitted
- 21 Oct 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT02942563
- Acronym / sponsor ID
- 2016CRC R-001
- Conditions
- Rectal Cancer
- Keywords
- Local Advanced Rectal Cancer, Total Neoadjuvant Therapy, FOLFOXIRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- 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.
The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them even more severer. A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological complete response (pCR), which was associated with overall survival (OS). Here, the investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent chemoradiation and to improve the ratio of pCR further.
Detailed description
This is a multicenter, phase II trial to assess the efficacy/safety of triplet regimen (FOLFOXIRI) for patients with LARC. After 4 cycles of FOLFOXIRI and 2 weeks later, the patients will be evaluated by senior radiologist, oncologist and surgeon through pelvic MRI, CT and Positron Emission Computed Tomography (PET-CT). The patients will go to surgery (TME) if the tumor response is good enough to have complete resection under the decision of MDT,otherwise, the patients will receive pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625mg/M^2, bid po, d1-5, qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m² bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME. All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI | Experimental | Drug: FOLFOXIRIirinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 to 75 years at diagnosis
- Diagnosis of rectal adenocarcinoma
- ECOG status: 0～1
- Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
Key exclusion criteria (7 listed)
- Patient had received pelvic radiotherapy
- Patient had received systemic chemotherapy
- Pregnant and Nursing women
- Had metastatic disease
- Uncontrolled co-morbid illnesses or other concurrent disease
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: Irinotecan, Oxaliplatin, 5-FU, CapecitabineIrinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle for 4-6 cycles, Chemoradiation for patients who are not suitable to surgery: Pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625mg/m², bid po, d1-5, qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m² bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME. All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME. | Drug | FOLFOXIRI |
Primary outcome
Pelvic complete resection rate
Time frame: Up to 10 weeks
Pathologic confirmation
7 secondary outcomes
The rate of local control
Time frame: 3 years
Disease free survival (DFS)
Time frame: 3 years
Overall survival
Time frame: 3 years
The rate of receive chemoradiation
Time frame: Up to 10 weeks
The rate of clinical complete response after 4 cycles of FOLFOXIRI
Time frame: Up to 10 weeks
The rate of pathological complete response after 4 cycles of FOLFOXIRI
Time frame: Up to 10 weeks
The incidence of >=3 grade adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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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. This study is not recruiting at the moment.
Ming Ye, Master principal investigator
Locations: China, Shanghai Shanghai Jiaotong University School of Medicine, Renji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOXIRI in people with Rectal Cancer, run by RenJi Hospital 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 7 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: status not confirmed, as of the sponsor's last update on 3 Jan 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Ye, Master (+862168383459, renjiyeming@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic complete resection rate (time frame: Up to 10 weeks). 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 3 Jan 2018.