Colon CancerPhase 2REVISENCT06242418
CtDNA in Adjuvant Chemotherapy of Stage III Colon Cancer (REVISE Trial)
A Phase 2 study testing FOLFOXIRI and XELOX in people with Colon Cancer, run by West China Hospital at 9 sites in China.
Trial summary
Colon cancer is one of the most common malignant tumors with an increasing incidence rate in China. Surgical resection is still the main treatment for colon cancer at present. Radical surgery followed by three/six months chemotherapy is the standard of care for stage III colon cancer; however, patients with different… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- FOLFOXIRI and XELOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesChina
- Study dates
- 25 Mar 2024to 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
- Age 18-75 years, regardless of gender.
- Tumor located in the colon (the distance from the lower margin of the tumor to the anus is greater than 12 cm).
- Radical surgery performed, with pathological stage III (T1-4N1-2M0) (AJCC TNM staging, 8th edition, 2017).
- No local or distant tumor recurrence was found in imaging examination.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
- adequate organ function: Hemoglobin ≥ 9 g/dL; WBC ≥ 3.5 × 109/ L; Neutrophils ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula); ALT and AST ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN.
- No history of allergy to fluoropyrimidines or platinum-based drugs.
- Voluntarily participating in this study, signing an informed consent form, good compliance, and cooperation with follow-up.
Who cannot join
- History of other malignant tumors within the past five years (excluding basal cell carcinoma and/or cervical carcinoma in situ after radical surgery).
- Patients with BRAF mutation status
- Patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) status
- Previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., for colon cancer.
- Patients considering lynch syndrome.
- Severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, severe primary hematological diseases.
Show all 14Show fewer
- severe mental disorders
- Any unstable condition or situation that may harm patient safety or compliance with the study, such as fertility needs, pregnancy, breastfeeding, depression, bipolar disorder, obsessive-compulsive disorder, or schizophrenia.
- Recently participated in or currently participating in other clinical trials of drugs.
- Patients deemed unsuitable for participation in this study by the investigator.
- Withdrew Criteria
- Severe adverse reactions to chemotherapy and being unable to continue chemotherapy
- Metastatic or recurrence disease prior to randomization
- Refusing further treatment at any time without reason
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengde, Sichuan, 610041
Ziqiang Wang
- Recruiting
People's Hospital of Sichuan Province
Chengdu, Sichuan
Pang Minghui
- Recruiting
Shang Jin Hospital of West China Hospital, Sichuan University
Chengdu, Sichuan
Wei Mingtian
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan
Liu Chao
- Recruiting
The Third People's Hospital of Chengdu
Chengdu, Sichuan
Zhang Yuanchuan
Wang Meng
- Recruiting
West China Tianfu Hospital, Sichuan University
Chengdu, Sichuan
Deng Xiangbing
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Zhen Yunhuan
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Zeng Yujian
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
Li Yunfeng
Liu Ping
About this study
Official title: Value of CtDNA in Surveillance of Adjuvant Chemosensitivity and Regimen Adjustment in Stage III Colon Cancer: a Phase II Randomized Controlled Trial (REVISE Trial)
Colon cancer is one of the most common malignant tumors with an increasing incidence rate in China. Surgical resection is still the main treatment for colon cancer at present. Radical surgery followed by three/six months chemotherapy is the standard of care for stage III colon cancer; however, patients with different risk factors have different prognosis. The IDEA trial divided stage III colon cancer patients into low-risk (T1-3/N1) and high-risk (T4 or N2) groups, and showed that for some low-risk patients, three months chemotherapy did not decrease survival outcomes, while for some high-risk patients, the recurrence risk was still high even after six months chemotherapy. Therefore, it's worth to explore other risk stratification factors beyond T and N stage for these patients.
Circulating tumor DNA (ctDNA) is derived from cancer cells and can be detected in blood. Literatures have reported that ctDNA can be used for tumor diagnosis, therapeutic monitoring, and prognosis assessment in multiple cancers, including colon cancer. The GERCOR-PRODIGE trial, an accompanying study of IDEA, reported that in the high-risk group of stage III colon cancer, patients with ctDNA-positive and receiving six months chemotherapy had similar prognosis to these with ctDNA-negative and receiving three months chemotherapy; in the low-risk group, patients with ctDNA-negative and receiving three or six months chemotherapy had similar prognosis to patients with ctDNA-positive and receiving 6 months chemotherapy, but patients with ctDNA-positive and receiving three months chemotherapy had the worst prognosis. The results of this trial suggests that ctDNA can be potentially used as a further stratification factor to guide adjuvant chemotherapy for stage III colon cancer.
Read more
Several RCTs have shown that double-drug regimens chemotherapy based on oxaliplatin (FOLFOX and XELOX) can improve the prognosis of patients with stage III colon cancer. Therefore, the ESMO, NCCN, and CSCO guidelines recommend FOLFOX or XELOX for stage III colon cancer. The 2-year disease-free survival rate of these patients who received FOLFOX or XELOX chemotherapy was about 80%. It is worth to further explore how to improve the prognosis of these patients. Recently, the triple-drug regimens of oxaliplatin, irinotecan, and fluoropyrimidine (FOLFOXIRI) has been found to be superior to FOLFOX or XELOX for metastatic colorectal cancer in terms of response rate and survival. Currently, research on FOLFOXIRI plus targeted therapy in metastatic colorectal cancer is progressing rapidly, but there is little research on the use of FOLFOXIRI as adjuvant chemotherapy for stage III colon cancer. There is an ongoing international multicenter phase III RCT comparing FOLFOXIRI and FOLFOX6 adjuvant chemotherapy for high-risk stage III colon cancer patients, but it did not further stratify patients based on postoperative ctDNA status, which may result in some patients receiving excessive chemotherapy.
The present study plans to enroll patients with stage III colon cancer with positive ctDNA within 1 month after surgery. These patients will receive 2 cycles of XELOX chemotherapy followed by retesting ctDNA. During the waiting period of the ctDNA results (approximately 3 weeks due to the testing time), all patients will receive another cycle of XELOX chemotherapy. If the ctDNA remains positive, the patients will be randomly assigned to receive 8 cycles of FOLFOXIRI as intensified adjuvant chemotherapy or 5 cycles of XELOX regimen as standard adjuvant chemotherapy. If the ctDNA is negative, the patients will continue to receive 5 cycles of XELOX chemotherapy. Within 3 weeks after the completion or termination of chemotherapy, ctDNA will be retested again. The aims of this study are to explore the value of ctDNA in surveillance of chemosensitivity and to preliminarily evaluate whether the intensified chemotherapy with FOLFOXIRI can increase ctDNA clearance as well as its safety in stage III colon cancer.
- Conditions
- Colon Cancer
- Being tested
- FOLFOXIRI, XELOX
- Keywords
- colon cancer, ctDNA, adjuvant chemotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRIDrug
Eight cycles of FOLFOXIRI: Oxaliplatin 85mg/m2 ivgtt over 2 hours on day 1, Irinotecan 165mg/m2 ivgtt over 90 minutes on day 1, Calcium folinate 400mg/m2 ivgtt over 2 hours on day 1, 5-Fluorouracil 2400mg/m2 civ48h; Each cycle lasts for 2 weeks.
XELOXDrug
Five cycles of XELOX: Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 bid from day 1 to day 14; Each cycle lasts for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI | Experimental | Eight cycles of FOLFOXIRI: Oxaliplatin 85mg/m2 ivgtt over 2 hours on day 1, Irinotecan 165mg/m2 ivgtt over 90 minutes on day 1, Calcium folinate 400mg/m2 ivgtt over 2 hours on day 1, 5-Fluorouracil 2400mg/m2 civ48h; Each cycle lasts for 2 weeks. Receives: Drug: FOLFOXIRI |
| XELOX | Active comparator | Five cycles of XELOX: Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 bid from day 1 to day 14; Each cycle lasts for 3 weeks. Receives: Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in value of ctDNA concentration
Defined as the change in value of ctDNA measured after 2 cycles of XELOX (ctDNA2) and after the completion or termination of chemotherapy (ctDNA3). △ctDNA= ctDNA3 - ctDNA2.
Measured: six months
Secondary outcomes (5)
ctDNA clearance rate
Defined as the proportion of patients whose ctDNA becomes negative after the completion or termination of chemotherapy to the total patient.
Measured: six months
disease-free survival
The time from randomization to local recurrence, distant metastasis, or death.
Measured: two years
metastasis-free survival
The time from randomization to distant metastasis.
Measured: two years
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0.
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0.
Measured: two years
quality of life as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
The EORTC QLQ-C30 consists of 30 items, including 5 functional scales (physical function, role function, cognitive function, emotional function, social function), 3 symptom scales (fatigue, pain, nausea and vomiting), 6 individual measurement items (dysphagia, loss of appetite, sleep disorders, constipation, diarrhea, economic difficulties), and 1 patient self-assessment item (overall health status). Each of the first 28 items score 1 to 4. The higher the score, the worse the quality of life. The last 2 items score 1 to 7. The higher the score, the best the quality of life.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start25 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by West China 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GeneCast Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Ziqiang Wang,MD, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242418
- Sponsor's protocol ID
- 2023#1998
- Acronym
- REVISE
- Status last verified
- Dec 2024
- First submitted
- 27 Jan 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers are encouraged to apply for the full study protocol, study data, and analytic code upon reasonable request by contacting the primary investigator (Ziqiang Wang).
Publications
Zhou J, Huang J, Zhou Z, Fan R, Deng X, Qiu M, Wu Q, Wang Z. Value of ctDNA in surveillance of adjuvant chemosensitivity and regimen adjustment in stage III colon cancer: a protocol for phase II multicentre randomised controlled trial (REVISE trial). BMJ Open. 2025 Jan 2;15(1):e090394. doi: 10.1136/bmjopen-2024-090394.
PubMed 39753246
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of CtDNA in Surveillance of Adjuvant Chemosensitivity and Regimen Adjustment in Stage III Colon Cancer: a Phase II Randomized Controlled Trial (REVISE Trial)
- ClinicalTrials.gov ID
- NCT06242418
- Acronym / sponsor ID
- REVISE / 2023#1998
- Conditions
- Colon Cancer
- Keywords
- colon cancer, ctDNA, adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- GeneCast Biotechnology Co., Ltd.
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2024 (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.
Colon cancer is one of the most common malignant tumors with an increasing incidence rate in China. Surgical resection is still the main treatment for colon cancer at present. Radical surgery followed by three/six months chemotherapy is the standard of care for stage III colon cancer; however, patients with different risk factors have different prognosis. The IDEA trial divided stage III colon cancer patients into low-risk (T1-3/N1) and high-risk (T4 or N2) groups, and showed that for some low-risk patients, three months chemotherapy did not decrease survival outcomes, while for some high-risk patients, the recurrence risk was still high even after six months chemotherapy. Therefore, it's worth to explore other risk stratification factors beyond T and N stage for these patients.
Circulating tumor DNA (ctDNA) is derived from cancer cells and can be detected in blood. Literatures have reported that ctDNA can be used for tumor diagnosis, therapeutic monitoring, and prognosis assessment in multiple cancers, including colon cancer. The GERCOR-PRODIGE trial, an accompanying study of IDEA, reported that in the high-risk group of stage III colon cancer, patients with ctDNA-positive and receiving six months chemotherapy had similar prognosis to these with ctDNA-negative and receiving three months chemotherapy; in the low-risk group, patients with ctDNA-negative and receiving three or six months chemotherapy had similar prognosis to patients with ctDNA-positive and receiving 6 months chemotherapy, but patients with ctDNA-positive and receiving three months chemotherapy had the worst prognosis. The results of this trial suggests that ctDNA can be potentially used as a further stratification factor to guide adjuvant chemotherapy for stage III colon cancer.
Several RCTs have shown that double-drug regimens chemotherapy based on oxaliplatin (FOLFOX and XELOX) can improve the prognosis of patients with stage III colon cancer. Therefore, the ESMO, NCCN, and CSCO guidelines recommend FOLFOX or XELOX for stage III colon cancer. The 2-year disease-free survival rate of these patients who received FOLFOX or XELOX chemotherapy was about 80%. It is worth to further explore how to improve the prognosis of these patients. Recently, the triple-drug regimens of oxaliplatin, irinotecan, and fluoropyrimidine (FOLFOXIRI) has been found to be superior to FOLFOX or XELOX for metastatic colorectal cancer in terms of response rate and survival. Currently, research on FOLFOXIRI plus targeted therapy in metastatic colorectal cancer is progressing rapidly, but there is little research on the use of FOLFOXIRI as adjuvant chemotherapy for stage III colon cancer. There is an ongoing international multicenter phase III RCT comparing FOLFOXIRI and FOLFOX6 adjuvant chemotherapy for high-risk stage III colon cancer patients, but it did not further stratify patients based on postoperative ctDNA status, which may result in some patients receiving excessive chemotherapy.
The present study plans to enroll patients with stage III colon cancer with positive ctDNA within 1 month after surgery. These patients will receive 2 cycles of XELOX chemotherapy followed by retesting ctDNA. During the waiting period of the ctDNA results (approximately 3 weeks due to the testing time), all patients will receive another cycle of XELOX chemotherapy. If the ctDNA remains positive, the patients will be randomly assigned to receive 8 cycles of FOLFOXIRI as intensified adjuvant chemotherapy or 5 cycles of XELOX regimen as standard adjuvant chemotherapy. If the ctDNA is negative, the patients will continue to receive 5 cycles of XELOX chemotherapy. Within 3 weeks after the completion or termination of chemotherapy, ctDNA will be retested again. The aims of this study are to explore the value of ctDNA in surveillance of chemosensitivity and to preliminarily evaluate whether the intensified chemotherapy with FOLFOXIRI can increase ctDNA clearance as well as its safety in stage III colon cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI | Experimental | Drug: FOLFOXIRIEight cycles of FOLFOXIRI: Oxaliplatin 85mg/m2 ivgtt over 2 hours on day 1, Irinotecan 165mg/m2 ivgtt over 90 minutes on day 1, Calcium folinate 400mg/m2 ivgtt over 2 hours on day 1, 5-Fluorouracil 2400mg/m2 civ48h; Each cycle lasts for 2 weeks. |
| XELOX | Active comparator | Drug: XELOXFive cycles of XELOX: Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 bid from day 1 to day 14; Each cycle lasts for 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years, regardless of gender.
- Tumor located in the colon (the distance from the lower margin of the tumor to the anus is greater than 12 cm).
- Radical surgery performed, with pathological stage III (T1-4N1-2M0) (AJCC TNM staging, 8th edition, 2017).
- No local or distant tumor recurrence was found in imaging examination.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
Key exclusion criteria (14 listed)
- History of other malignant tumors within the past five years (excluding basal cell carcinoma and/or cervical carcinoma in situ after radical surgery).
- Patients with BRAF mutation status
- Patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) status
- Previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., for colon cancer.
- Patients considering lynch syndrome.
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 |
|---|---|---|
| FOLFOXIRIEight cycles of FOLFOXIRI: Oxaliplatin 85mg/m2 ivgtt over 2 hours on day 1, Irinotecan 165mg/m2 ivgtt over 90 minutes on day 1, Calcium folinate 400mg/m2 ivgtt over 2 hours on day 1, 5-Fluorouracil 2400mg/m2 civ48h; Each cycle lasts for 2 weeks. | Drug | FOLFOXIRI |
| XELOXFive cycles of XELOX: Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 bid from day 1 to day 14; Each cycle lasts for 3 weeks. | Drug | XELOX |
Primary outcome
change in value of ctDNA concentration
Time frame: six months
Defined as the change in value of ctDNA measured after 2 cycles of XELOX (ctDNA2) and after the completion or termination of chemotherapy (ctDNA3). △ctDNA= ctDNA3 - ctDNA2.
5 secondary outcomes
ctDNA clearance rate
Time frame: six months
disease-free survival
Time frame: two years
metastasis-free survival
Time frame: two years
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0.
Time frame: two years
quality of life as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: two 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 12 Dec 2024.
- Derived from this study: PubMed 39753246Zhou J, Huang J, Zhou Z, Fan R, Deng X, Qiu M, Wu Q, Wang Z. Value of ctDNA in surveillance of adjuvant chemosensitivity and regimen adjustment in stage III colon cancer: a protocol for phase II multicentre randomised controlled trial (REVISE trial). BMJ Open. 2025 Jan 2;15(1):e090394. doi: 10.1136/bmjopen-2024-090394.
- Individual participant dataSharing planned: Yes. Researchers are encouraged to apply for the full study protocol, study data, and analytic code upon reasonable request by contacting the primary investigator (Ziqiang Wang).
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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.
9 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 FOLFOXIRI and XELOX in people with Colon Cancer, run by West China Hospital at 9 sites 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 8 inclusion and 14 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 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Ziqiang Wang (+8685422480, wangziqiang@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in value of ctDNA concentration (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242418, which also lists 1 linked publication.
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 12 Dec 2024.