Metastatic Colon CancerPhase 2NCT02618356
Combined Use of Raltitrexed and S-1 as Treatment for Patients With Metastasizing Colorectal Cancer
A Phase 2 study testing Raltitrexed and S-1 in people with Metastatic Colon Cancer, run by Fudan University at 1 site in China.
Trial summary
The primary endpoint is to evaluate the Median disease progression free survival (mPFS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Colon Cancer
- What is being tested?
- Raltitrexed and S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2015to Nov 2017
- 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
- ≥18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum 3. No systemic chemotherapy for metastatic tumors
- 4. ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 3 months or more 5. At least one measurable objective tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 6. ANC≥1.5109/L；PLT≥80109/L；HB≥90g/L；Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) ; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)；ALB ≥ 30g/L; Serum creatinine ≤1.5(ULN) or glomerular filtration rate (GFR) ≥60 ml/min screening within 7 days 7. Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan. Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible. Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. Subjects may have received prior treatment with Avastin (bevacizumab) and/or Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT) 8. Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent.
Who cannot join
- Prior treatment with raltitrexed and gimeracil and oteracil potassium
- Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy and hormonal therapy during this trial or within 4 weeks (or 6 weeks for mitomycin C) before starting to receive study medication.
- Alcohol or drug addictions
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]
- Any history of or currently known brain metastases
- Multiple primary colorectal carcinoma
Show all 13Show fewer
- Concomitant participation or participation within the last 30 days in another clinical trial
- There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation.
- Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization. Subjects must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
- Pleural effusion or ascites that causes respiratory compromise (≥Common Terminology Criteria for Adverse Events [CTCAE]) Grade 2 dyspnea)
- Subjects unable to swallow oral medications
- Known history of human immunodeficiency virus (HIV) infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Wei Jian Guo, 13816066360, mingzhuhuang0718@163.com
About this study
Official title: A Phase II Clinical Study of Combined Use of Raltitrexed and S-1 as Treatment for Patients With Metastasizing Colorectal Cancer Failed of Standard Chemotherapy
The primary endpoint is to evaluate the Median disease progression free survival (mPFS).
Read the detailed description
The primary endpoint is to evaluate the disease progression free survival (mPFS) of Raltitrexed combined with S-1 as treatment for patients with metastasizing colorectal cancer failed of standard chemotherapy
- Conditions
- Metastatic Colon Cancer
- Being tested
- Raltitrexed and S-1
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltitrexed and S-1Drug
Also called Tomudex, Gimeracil and oteracil porassium
Raltitrexed 3mg/m2 intravenously guttae, d1 and S-1,bid,po,d1-d14,every three weeks for a cycle.
BSA (body surface area) S-1 dosage <1.25 m2 80 mg/d
- 1.25m2 - <1.5 m2 100 mg/d
- 1.5 m2 120 mg/d
| Study group | Role | What they receive |
|---|---|---|
| combined use Raltitrexed and S-1 | Experimental | Raltitrexed 3mg/m2 intravenously guttae, d1 and S-1,bid,po,d1-d14,every three weeks for a cycle.
BSA(body surface area) S-1 dosage <1.25 m2 80 mg/d
* 1.25m2 - <1.5 m2 100 mg/d
* 1.5 m2 120 mg/d Receives: Drug: Raltitrexed and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median disease progression free survival (mPFS) of Raltitrexed combined with S-1
Measured: at least 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start25 Dec 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (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 Metastatic Colon 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
- Investigators
- Wei Jian Guo, doctor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618356
- Sponsor's protocol ID
- guoweijian-2015-RS
- Status last verified
- Sep 2017
- First submitted
- 17 Nov 2015
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang M, Yang Y, Zhu X, Chen Z, Zhang W, Wang C, Zhang X, Qiu L, Zhang Z, Zhao X, Li W, Wang Y, Guo W. A prospective phase II study of raltitrexed combined with S-1 as salvage treatment for patients with refractory metastatic colorectal cancer. Asia Pac J Clin Oncol. 2021 Dec;17(6):513-521. doi: 10.1111/ajco.13511. Epub 2021 Feb 10.
PubMed 33567129
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Combined Use of Raltitrexed and S-1 as Treatment for Patients With Metastasizing Colorectal Cancer Failed of Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT02618356
- Acronym / sponsor ID
- guoweijian-2015-RS
- Conditions
- Metastatic Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 Dec 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 1 Dec 2015 (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 primary endpoint is to evaluate the Median disease progression free survival (mPFS).
Detailed description
The primary endpoint is to evaluate the disease progression free survival (mPFS) of Raltitrexed combined with S-1 as treatment for patients with metastasizing colorectal cancer failed of standard chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combined use Raltitrexed and S-1 | Experimental | Drug: Raltitrexed and S-1Raltitrexed 3mg/m2 intravenously guttae, d1 and S-1,bid,po,d1-d14,every three weeks for a cycle. BSA(body surface area) S-1 dosage <1.25 m2 80 mg/d * 1.25m2 - <1.5 m2 100 mg/d * 1.5 m2 120 mg/d |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum 3. No systemic chemotherapy for metastatic tumors
- 4. ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 3 months or more 5. At least one measurable objective tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 6. ANC≥1.5109/L；PLT≥80109/L；HB≥90g/L；Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) ; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)；ALB ≥ 30g/L; Serum creatinine ≤1.5(ULN) or glomerular filtration rate (GFR) ≥60 ml/min screening within 7 days 7. Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan. Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible. Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. Subjects may have received prior treatment with Avastin (bevacizumab) and/or Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT) 8. Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent.
Key exclusion criteria (13 listed)
- Prior treatment with raltitrexed and gimeracil and oteracil potassium
- Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy and hormonal therapy during this trial or within 4 weeks (or 6 weeks for mitomycin C) before starting to receive study medication.
- Alcohol or drug addictions
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]
- Any history of or currently known brain metastases
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 |
|---|---|---|
| Raltitrexed and S-1Also: Tomudex, Gimeracil and oteracil porassiumRaltitrexed 3mg/m2 intravenously guttae, d1 and S-1,bid,po,d1-d14,every three weeks for a cycle. BSA (body surface area) S-1 dosage <1.25 m2 80 mg/d * 1.25m2 - <1.5 m2 100 mg/d * 1.5 m2 120 mg/d | Drug | combined use Raltitrexed and S-1 |
Primary outcome
Median disease progression free survival (mPFS) of Raltitrexed combined with S-1
Time frame: at least 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Derived from this study: PubMed 33567129Huang M, Yang Y, Zhu X, Chen Z, Zhang W, Wang C, Zhang X, Qiu L, Zhang Z, Zhao X, Li W, Wang Y, Guo W. A prospective phase II study of raltitrexed combined with S-1 as salvage treatment for patients with refractory metastatic colorectal cancer. Asia Pac J Clin Oncol. 2021 Dec;17(6):513-521. doi: 10.1111/ajco.13511. Epub 2021 Feb 10.
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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.
Wei Jian Guo, doctor study chair
Fudan University
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 Raltitrexed and S-1 in people with Metastatic Colon 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 3 inclusion and 13 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 2 Oct 2017. 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 Wei Jian Guo, doctor (13816066360, mingzhuhuang0718@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median disease progression free survival (mPFS) of Raltitrexed combined with S-1 (time frame: at least 24 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 NCT02618356, 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 2 Oct 2017.