Colorectal CancerPhase 1/2NCT03564912
Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in CRC
A Phase 1/2 study testing Capecitabine Oral Tablet [Xeloda] in people with Colorectal Cancer, run by Zhejiang University at 1 site in China.
Trial summary
This study select the diagnosis of postoperative colorectal cancer patients with stage II/III to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Capecitabine Oral Tablet [Xeloda]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2018to 24 Aug 2021
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Carcinoma of the intestine confirmed histologically or cytologically
- Radical surgical resection was performed after diagnosis and the post operative stages were high-risk II or III patients
- The ECOG PS score less than or equal to 2 points
- No chemotherapy of any kind has been performed in the past
- Neutrophils acuity 1.5x10e9/L, platelets more than 100x10e9/L, college blood red protein more than 9g/dL
- liver function transaminase is less than or equal to 2.5 ULN, alkaline phosphatase is less than 2.5 ULN, and total bilirubin is less than 1.5 ULN
Who cannot join
- Patients with unresectable CRC
- Patients who have any form of chemotherapy before
- Participating in or having participated in clinical studies of other drug
- Patients have second primary malignant tumors of have other malignant tumors in the past five years
- There is evidence of allergic reaction to drugs in this study
- A history of ischemic heart disease in the past 1 year or patients with high risk factors for heart failure, or uncontrolled arrhythmias
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- Severe active inflammation, including tuberculosis and HIV
- Long-term immunization or hormone therapy, except hormone replacement therapy at physiological dose
- Drug or alcohol addiction
- Get pregnant or breastfeed
- The investigator considers that the patient is not suitable for this clinical study due to any clinical or laboratory abnormalities or compliance problems
Trial locations and contacts
1 site in 1 country.
China1 site
First afflicated hospital of zhejiang university
Hangzhou, Zhejiang, 310000
About this study
Official title: Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery
This study select the diagnosis of postoperative colorectal cancer patients with stage II/III to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. To analyze the difference in efficacy and safety of xelox in 2 weeks and 3 weeks of postoperative adjuvant therapy for colorectal cancer, so as to find a better postoperative adjuvant treatment model.
- Conditions
- Colorectal Cancer
- Being tested
- Capecitabine Oral Tablet [Xeloda]
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine Oral Tablet [Xeloda]Drug
Also called oxaliplatin
2 week group: capecitabine 1000mg/m2 d1-10; oxaliplatin 85mg/m2; q2w 3 week group: capecitabine 1000mg/m2 d1-14; oxaliplatin 130mg/m2; q3w
| Study group | Role | What they receive |
|---|---|---|
| 2 week group | Experimental | Not described Receives: Drug: Capecitabine Oral Tablet [Xeloda] |
| 3 week group | Active comparator | Not described Receives: Drug: Capecitabine Oral Tablet [Xeloda] |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
disease free survival
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
toxicity difference of two groups
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start12 Aug 2018
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564912
- Sponsor's protocol ID
- ZhejiangU020
- Status last verified
- Aug 2021
- First submitted
- 27 May 2018
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhang H, Wang D, Tong Z, Xiang T, Zhu X, Liu L, Zheng Y, Zhao P, Fang W, Chen W. Biweekly CAPOX versus triweekly CAPOX in the adjuvant therapy of post-surgery CRC: A randomized controlled trial. PLoS One. 2025 Jul 11;20(7):e0313472. doi: 10.1371/journal.pone.0313472. eCollection 2025.
PubMed 40644418
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery
- ClinicalTrials.gov ID
- NCT03564912
- Acronym / sponsor ID
- ZhejiangU020
- Conditions
- Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 12 Aug 2018 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 21 Jun 2018 (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 study select the diagnosis of postoperative colorectal cancer patients with stage II/III to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. To analyze the difference in efficacy and safety of xelox in 2 weeks and 3 weeks of postoperative adjuvant therapy for colorectal cancer, so as to find a better postoperative adjuvant treatment model.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 week group | Experimental | Drug: Capecitabine Oral Tablet [Xeloda] |
| 3 week group | Active comparator | Drug: Capecitabine Oral Tablet [Xeloda] |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Carcinoma of the intestine confirmed histologically or cytologically
- Radical surgical resection was performed after diagnosis and the post operative stages were high-risk II or III patients
- The ECOG PS score less than or equal to 2 points
- No chemotherapy of any kind has been performed in the past
- Neutrophils acuity 1.5x10e9/L, platelets more than 100x10e9/L, college blood red protein more than 9g/dL
Key exclusion criteria (11 listed)
- Patients with unresectable CRC
- Patients who have any form of chemotherapy before
- Participating in or having participated in clinical studies of other drug
- Patients have second primary malignant tumors of have other malignant tumors in the past five years
- There is evidence of allergic reaction to drugs in 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 |
|---|---|---|
| Capecitabine Oral Tablet [Xeloda]Also: oxaliplatin2 week group: capecitabine 1000mg/m2 d1-10; oxaliplatin 85mg/m2; q2w 3 week group: capecitabine 1000mg/m2 d1-14; oxaliplatin 130mg/m2; q3w | Drug | 2 week group, 3 week group |
Primary outcome
DFS
Time frame: through study completion, an average of 1 year
disease free survival
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 40644418Zhang H, Wang D, Tong Z, Xiang T, Zhu X, Liu L, Zheng Y, Zhao P, Fang W, Chen W. Biweekly CAPOX versus triweekly CAPOX in the adjuvant therapy of post-surgery CRC: A randomized controlled trial. PLoS One. 2025 Jul 11;20(7):e0313472. doi: 10.1371/journal.pone.0313472. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Capecitabine Oral Tablet [Xeloda] in people with Colorectal Cancer, run by Zhejiang 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 25 Aug 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: through study completion, an average of 1 year). 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 NCT03564912, 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 25 Aug 2021.