Colorectal NeoplasmPhase 2NCT02870153
SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer
A Phase 2 study testing SOX and XELOX in people with Colorectal Neoplasm, run by The First People's Hospital of Changzhou at 1 site in China.
Trial summary
The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (SOX) and Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- SOX and XELOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jun 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
- Peritoneal metastasis of colorectal cancer
- At least one uni-dimensional measurable lesion by RECIST criteria
- Age 18 to 80 years old
- Estimated life expectancy ≥3 months
- ECOG performance status ≤2
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- Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)
- Adequate kidney function (creatinine < 1.5 mg/dL)
- Adequate liver function (bilirubin < 2.0 mg/dL, transaminase levels <2.5 times the upper normal limit)
- Written informed consent
Who cannot join
- Other tumor type than adenocarcinoma
- Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
- Presence of CNS metastasis, psychosis, or seizure
- Obvious bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003
Liangrong Shi, M.D., 86-519-68871122, shiliangr@126.com
About this study
Official title: A Randomized Phase II Study of Oxaliplatin and S-1 (SOX) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Peritoneal Metastasis of Colorectal Cancer
The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (SOX) and Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of colorectal cancer.
Read the detailed description
Peritoneal dissemination from colorectal cancer is common, and it has been traditionally regarded as end-stage disease only amenable to palliation by systemic chemotherapy (sCT), or supportive care .Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and several phase II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.
- Conditions
- Colorectal Neoplasm
- Being tested
- SOX, XELOX
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOXDrug
Also called Eloxatin, TS-1
Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days
XELOXDrug
Also called Eloxatin, Xeloda
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| SOX(oxalipaltin+S-1) | Experimental | Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days Receives: Drug: SOX |
| XELOX (oxalipaltin+capecitabine) | Active comparator | Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days Receives: Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
According to the RECIST criterion
Measured: 6 weeks
Secondary outcomes (3)
Side-effect
Safety was evaluated according to the NCI-CTC
Measured: 8 weeks
Time to Progression
According to the RECIST criterion
Measured: 6 years
Overall Survival
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionJan 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changping Wu, M.D., Study director, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870153
- Sponsor's protocol ID
- CZYY-CRC-007
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Baratti D, Kusamura S, Pietrantonio F, Guaglio M, Niger M, Deraco M. Progress in treatments for colorectal cancer peritoneal metastases during the years 2010-2015. A systematic review. Crit Rev Oncol Hematol. 2016 Apr;100:209-22. doi: 10.1016/j.critrevonc.2016.01.017. Epub 2016 Jan 22.
PubMed 26867984Esquivel J. Colorectal cancer with peritoneal metastases: Progress, not perfection. J Surg Oncol. 2015 Jul;112(1):115. doi: 10.1002/jso.23954. Epub 2015 Jul 7. No abstract available.
PubMed 26153356Ogawa M, Anan T, Suzuki T, Okuma M, Ichihara K, Hasegawa T, Yoshida K, Yanaga K. Initial Report of Phase II Study on Bi-weekly SOX plus Cetuximab Treatment for Wild-type K-RAS Advanced and Recurrent Colorectal Cancer. Anticancer Res. 2016 May;36(5):2505-11.
PubMed 27127165Wang ZQ, Zhang DS, Xu N, Luo DY, Deng YH, Wang FH, Luo HY, Qiu MZ, Li YH, Xu RH. Phase II study of oxaliplatin combined with S-1 and leucovorin (SOL) for Chinese patients with metastatic colorectal cancer. Chin J Cancer. 2016 Jan 6;35:8. doi: 10.1186/s40880-015-0061-3.
PubMed 26739998
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Oxaliplatin and S-1 (SOX) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Peritoneal Metastasis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02870153
- Acronym / sponsor ID
- CZYY-CRC-007
- Conditions
- Colorectal Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 17 Aug 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 aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (SOX) and Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of colorectal cancer.
Detailed description
Peritoneal dissemination from colorectal cancer is common, and it has been traditionally regarded as end-stage disease only amenable to palliation by systemic chemotherapy (sCT), or supportive care .Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and several phase II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOX(oxalipaltin+S-1) | Experimental | Drug: SOXOxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days |
| XELOX (oxalipaltin+capecitabine) | Active comparator | Drug: XELOXOxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
- Peritoneal metastasis of colorectal cancer
- At least one uni-dimensional measurable lesion by RECIST criteria
- Age 18 to 80 years old
- Estimated life expectancy ≥3 months
Key exclusion criteria (8 listed)
- Other tumor type than adenocarcinoma
- Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
- Presence of CNS metastasis, psychosis, or seizure
- Obvious bowel obstruction
- Evidence of serious gastrointestinal bleeding
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 |
|---|---|---|
| SOXAlso: Eloxatin, TS-1Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days | Drug | SOX(oxalipaltin+S-1) |
| XELOXAlso: Eloxatin, XelodaOxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days | Drug | XELOX (oxalipaltin+capecitabine) |
Primary outcome
Response Rate
Time frame: 6 weeks
According to the RECIST criterion
3 secondary outcomes
Side-effect
Time frame: 8 weeks
Time to Progression
Time frame: 6 years
Overall Survival
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Background: PubMed 26867984Baratti D, Kusamura S, Pietrantonio F, Guaglio M, Niger M, Deraco M. Progress in treatments for colorectal cancer peritoneal metastases during the years 2010-2015. A systematic review. Crit Rev Oncol Hematol. 2016 Apr;100:209-22. doi: 10.1016/j.critrevonc.2016.01.017. Epub 2016 Jan 22.
- Background: PubMed 26153356Esquivel J. Colorectal cancer with peritoneal metastases: Progress, not perfection. J Surg Oncol. 2015 Jul;112(1):115. doi: 10.1002/jso.23954. Epub 2015 Jul 7. No abstract available.
- Background: PubMed 27127165Ogawa M, Anan T, Suzuki T, Okuma M, Ichihara K, Hasegawa T, Yoshida K, Yanaga K. Initial Report of Phase II Study on Bi-weekly SOX plus Cetuximab Treatment for Wild-type K-RAS Advanced and Recurrent Colorectal Cancer. Anticancer Res. 2016 May;36(5):2505-11.
- Background: PubMed 26739998Wang ZQ, Zhang DS, Xu N, Luo DY, Deng YH, Wang FH, Luo HY, Qiu MZ, Li YH, Xu RH. Phase II study of oxaliplatin combined with S-1 and leucovorin (SOL) for Chinese patients with metastatic colorectal cancer. Chin J Cancer. 2016 Jan 6;35:8. doi: 10.1186/s40880-015-0061-3.
- Individual participant dataSharing planned: Yes
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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.
Changping Wu, M.D. study director
The First People's Hospital of Changzhou
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 SOX and XELOX in people with Colorectal Neoplasm, run by The First People's Hospital of Changzhou 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 10 inclusion and 8 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 19 Aug 2016. 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 Jiemin Zhao, M.D. (86-519-68871122, 210328010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 6 weeks). 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 NCT02870153, which also lists 4 linked publications.
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 19 Aug 2016.