Rectal CancerPhase 2NCT04443543
An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer
A Phase 2 study testing Capecitabine (Xeloda) Pharmacogenetic Test Reagents, irinotecan and IMRT in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life… 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?
- Capecitabine (Xeloda) Pharmacogenetic Test Reagents, irinotecan and IMRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2020to 31 Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathological confirmed adenocarcinoma
- clinical stage T2-4 and/or N+, inappropriate for local excision
- the distance from anal verge less than 5 cm, or considered inappropriate for anal preservation by surgeons.
- Strong desire to preserve the anus, able to receive close surveillance for at least 2 years after chemoradiotherapy.
- without distance metastases
- aged between 18 to 75 years old.
Show all 9Show fewer
- performance status score: 0~1
- UGT1A1*28 6/6 or 6/7
- sign the inform consent
Who cannot join
- pregnancy or breast-feeding women
- serious medical illness
- difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor >10cm; the maximal diameter of lateral lymph node >2cm; baseline CEA>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri-narrowed.
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- DPD deficiency
- UGT1A1*28 7/7
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
Fudan University Shanghai Cancer Cencer
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Chemoradiotherapy: A Multi-centre, Adaptive-design, Phase II Prospective Cohort Study
The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, DFS and OS.
Read the detailed description
- Primary objective: Evaluate the CCR rate of low rectal cancer using adaptive and optimized chemotherapy and radiotherapy strategies (all population and dMMR/MSI-H subgroup)
- Secondary objectives: 2.1 Evaluate the 2-year anal preservation rate, recurrence rate, quality of life, DFS and OS 2.2 Explore the subgroup of patients suitable for observation.
- Outline:
Patients after long-course chemoradiation are grouped based on their MSI-H/dMMR status. For patients with MSI-H/dMMR, consolidation immunotherapy of Tislelizumab (BGB-A317) will be assigned. For patients with MSS/pMMR, consolidation chemotherapy will be given according to their tumor response. After completion of consolidation therapy, those who reach clinical complete response will receive organ preservation (watch and wait) strategy in place of radical surgery. During treatment, once local regrowth occurs or poor tumor response, total mesorectal excision (TME) surgery will be performed.
- Conditions
- Rectal Cancer
- Being tested
- Capecitabine (Xeloda) Pharmacogenetic Test Reagents, irinotecan, IMRT, Oxaliplatin, 5Fluorouracil
- Keywords
- Chemoradiotherapy, organ preservation, watch and wait, irinotecan, Tislelizumab, capecitabine
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda) Pharmacogenetic Test ReagentsDrug
CRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14
irinotecanDrug
CRT:80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1
IMRTRadiation
Pelvic Radiation: 50Gy/25Fx
OxaliplatinDrug
FOLFIRINOX: 85mg/m2 d1
5FluorouracilDrug
FOLFIRINOX: 400mg/m2 iv d1bolus, 2400mg/m2 ivgtt 46h
TislelizumabDrug
200mg iv
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Arm 1 includes patients with MSS/pMMR. In this arm, patients receive consolidation chemotherapy after neoadjuvant chemoradiation (nCRT). The chemotherapy regimens either XELIRI or FOLFIRINOX, and the cycles of chemotherapy depend on patient tumor responses. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery. Receives: Drug: Capecitabine (Xeloda) Pharmacogenetic Test Reagents; Drug: irinotecan; Radiation: IMRT; Drug: Oxaliplatin; Drug: 5Fluorouracil |
| Arm 2 | Experimental | Arm 2 includes patients with MSI-H/dMMR status. In this arm, patients receive consolidation immunotherapy of 3 cycles of tislelizumab after nCRT. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery. Receives: Drug: Capecitabine (Xeloda) Pharmacogenetic Test Reagents; Drug: irinotecan; Radiation: IMRT; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical complete response rate
After nCRT, the lesions of rectal completely respond. Tumor residue cannot be found by digital rectal examination, endoscopic biopsy and radiology.
Measured: two weeks after completion of CRT or consolidation chemotherapy.
Secondary outcomes (4)
2y-anal preservation rate
2-year anal preservation rate will be defined as the percentage of patients alive without receiving abdominoperineal resection at 2 years measured from the date of completion of CRT.
Measured: 2 years
2y-local recurrence rate
2-year local recurrence rate will be defined as the percentage of patients alive developing local recurrence at 2 years measured from the date of completion of CRT.
Measured: 2 years
Impact of participants' quality of life
quality of life is evaluated according to EORTC C-30 questionnare.
Measured: 2 years
overall survival
3-year OS will be defined as the percentage of patients alive at 3 years measured from the date of completion of CRT.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start22 Jun 2020 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Ji, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443543
- Sponsor's protocol ID
- CARTOnG-2001
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Chemoradiotherapy: A Multi-centre, Adaptive-design, Phase II Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04443543
- Acronym / sponsor ID
- CARTOnG-2001
- Conditions
- Rectal Cancer
- Keywords
- Chemoradiotherapy, organ preservation, watch and wait, irinotecan, Tislelizumab, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 22 Jun 2020 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jun 2020 (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.
The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, DFS and OS.
Detailed description
- Primary objective: Evaluate the CCR rate of low rectal cancer using adaptive and optimized chemotherapy and radiotherapy strategies (all population and dMMR/MSI-H subgroup)
- Secondary objectives: 2.1 Evaluate the 2-year anal preservation rate, recurrence rate, quality of life, DFS and OS 2.2 Explore the subgroup of patients suitable for observation.
- Outline:
Patients after long-course chemoradiation are grouped based on their MSI-H/dMMR status. For patients with MSI-H/dMMR, consolidation immunotherapy of Tislelizumab (BGB-A317) will be assigned. For patients with MSS/pMMR, consolidation chemotherapy will be given according to their tumor response. After completion of consolidation therapy, those who reach clinical complete response will receive organ preservation (watch and wait) strategy in place of radical surgery. During treatment, once local regrowth occurs or poor tumor response, total mesorectal excision (TME) surgery will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Capecitabine (Xeloda) Pharmacogenetic Test Reagents, Drug: irinotecan, Radiation: IMRT, Drug: Oxaliplatin, Drug: 5FluorouracilArm 1 includes patients with MSS/pMMR. In this arm, patients receive consolidation chemotherapy after neoadjuvant chemoradiation (nCRT). The chemotherapy regimens either XELIRI or FOLFIRINOX, and the cycles of chemotherapy depend on patient tumor responses. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery. |
| Arm 2 | Experimental | Drug: Capecitabine (Xeloda) Pharmacogenetic Test Reagents, Drug: irinotecan, Radiation: IMRT, Drug: TislelizumabArm 2 includes patients with MSI-H/dMMR status. In this arm, patients receive consolidation immunotherapy of 3 cycles of tislelizumab after nCRT. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- pathological confirmed adenocarcinoma
- clinical stage T2-4 and/or N+, inappropriate for local excision
- the distance from anal verge less than 5 cm, or considered inappropriate for anal preservation by surgeons.
- Strong desire to preserve the anus, able to receive close surveillance for at least 2 years after chemoradiotherapy.
- without distance metastases
Key exclusion criteria (6 listed)
- pregnancy or breast-feeding women
- serious medical illness
- difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor >10cm; the maximal diameter of lateral lymph node >2cm; baseline CEA>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri-narrowed.
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- DPD deficiency
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 |
|---|---|---|
| Capecitabine (Xeloda) Pharmacogenetic Test ReagentsCRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14 | Drug | Arm 1, Arm 2 |
| irinotecanCRT:80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1 | Drug | Arm 1, Arm 2 |
| IMRTPelvic Radiation: 50Gy/25Fx | Radiation | Arm 1, Arm 2 |
| OxaliplatinFOLFIRINOX: 85mg/m2 d1 | Drug | Arm 1 |
| 5FluorouracilFOLFIRINOX: 400mg/m2 iv d1bolus, 2400mg/m2 ivgtt 46h | Drug | Arm 1 |
| Tislelizumab200mg iv | Drug | Arm 2 |
Primary outcome
clinical complete response rate
Time frame: two weeks after completion of CRT or consolidation chemotherapy.
After nCRT, the lesions of rectal completely respond. Tumor residue cannot be found by digital rectal examination, endoscopic biopsy and radiology.
4 secondary outcomes
2y-anal preservation rate
Time frame: 2 years
2y-local recurrence rate
Time frame: 2 years
Impact of participants' quality of life
Time frame: 2 years
overall survival
Time frame: 3 years
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 30 Jun 2020.
- 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.
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 Capecitabine (Xeloda) Pharmacogenetic Test Reagents, irinotecan and IMRT 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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Jun 2020. 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?
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 Ji Zhu (+86-2164175590 ext. 81607, leo.zhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical complete response rate (time frame: two weeks after completion of CRT or consolidation chemotherapy.). 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 30 Jun 2020.