Metastatic Colorectal CancerPhase 2NCT03485027
Rechallenge of Prior Regimen in Third or Later-line Chemotherapy in Metastatic Colorectal Cancer
A Phase 2 study testing the rechallenge regimen in people with Metastatic Colorectal Cancer and Chemotherapy Effect, run by Fudan University at 1 site in China.
Trial summary
This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Colorectal Cancer, Chemotherapy Effect
- What is being tested?
- the rechallenge regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2018to 1 Jul 2023
- 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
- Patients age between 18 and 80 years
- Histologically confirmed metastatic colorectal cancer (mCRC)
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Treatment failure to at least two lines of chemotherapy (regimens should include oxaliplatin, fluorouracil and irinotecan); progression free survival (PFS) of prior oxaliplatin or irinotecan-based chemotherapy should be at least four months without any unrecoverable toxicity. Prior target therapy was acceptable
- For those who received other anti-tumor treatment, the toxicity should have been restored, with the time interval from last dose of cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥3 weeks
- Life expectancy≥12 weeks
Show all 9Show fewer
- At least one measurable lesion as defined by RECIST 1.1
- Acceptable hematologic, hepatic, and renal function within 7 days from screening: the blood ANC count≥1.5*10^9/L; hemoglobin≥9.0 g/dl, the blood platelet count≥80 x 10^9/L, total bilirubin<1.5*upper limits of normal(ULN), ALT and AST<2.5*ULN(< 5 *ULN for patients with live metastasis), endogenous creatinine clearance rate>50ml/min
- Targeted drugs are currently not suitable or affordable
Who cannot join
- Receiving other systemic anti-cancer treatment within 3 weeks
- Prior radiation therapy of target measurable lesion
- Presence of Grade III or IV chemo-related toxicity in previous treatment without recovery to Grade II or less
- With other malignant tumor in 5 years; except for cured cervical carcinoma in situ or basal cell carcinoma
- Symptomatic intracranial or meningeal metastasis
- History of uncontrolled seizures, central nervous system dysfunction or mental disorder
- Uncontrolled pleural or peritoneal effusion
- Severe life-threatening concomitant disease that might impair the safety of patients or affect the completion of treatment, according to the researcher's judgment
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase II Clinical Trial of Prior Regimen Rechallenge in Third or Later-line Chemotherapy for Patients With Metastatic Colorectal Cancer
This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in previous treatment and could not receive the target therapy presently are planned for recruitment. For patients with metastatic colorectal cancer who met admission criteria, oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated every 6 weeks. The treatment continues until the disease progression or the untolerable adverse reaction.
Read the detailed description
The treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen.
Optional chemotherapy regimen included XELOX,FOLFOX,FOLFIRI,Irinotecan single-agent
- Conditions
- Metastatic Colorectal Cancer, Chemotherapy Effect
- Being tested
- the rechallenge regimen
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the rechallenge regimenDrug
Also called reintroduction of the former regimens in the third or later line treatment even after the same treatment had shown drug-resistance in the former setting
XELOX regimen: Oxaliplatin 130mg/m2, intravenous, on day 1; Capecitabine 1000mg/m2, oral, twice daily, continuously for 14 days; ±bevacizumab 7.5mg/kg, intravenous, on day 1; repeating every 3 weeks. FOLFOX regimen: Oxaliplatin 85mg/m2 on day 1; Calcium folinate 400mg/m2 on day 1; 5-FU 400mg/m2 on day 1; 5-FU 2.4g/m2, continuous intravenous infusion for 46 hours, ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. FOLFIRI regimen: Irinotecan 180mg/m2 on day 1; Calcium folinate 400mg/m2 on day 1; 5-FU 400mg/m2 on day 1; 5-FU 2.4g/m2, continuous intravenous infusion for 46 hours; ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. Irinotecan monotherapy regimen: Irinotecan 180mg/m2 on day 1, ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. Raltitrexed contained regimen: Raltitrexed 3mg/m2 on day 1; ± Bevacizumab 7.5mg/kg, repeating every 3 weeks; Raltitrexed 2mg/m2 on day 1; ± Cetuximab 500mg/m2, repeating every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The rechallenge regimens | Experimental | XELOX ± BEV, repeating every 3 weeks.
FOLFOX ± BEV, repeating every 2 week
FOLFOX ± Cetuximab, repeating every 2 week
FOLFIRI ± BEV, repeating every 2 weeks.
FOLFIRI ± Cetuximab, repeating every 2 weeks.
IRI ± BEV, repeating every 2 weeks.
IRI ± Cetuximab, repeating every 2 weeks.
Raltitrexed ± BEV, repeating every 3 weeks.
Raltitrexed ± Cetuximab, repeating every 2 weeks. Receives: Drug: the rechallenge regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: from the time signing of informed consent form(ICF) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Secondary outcomes (1)
OS
overall survival
Measured: from the time signing of ICF until the date of death from any cause, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start24 Jan 2018
- Primary completion24 Dec 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal 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
- Single group
- Model description
- investigator chose the optimal reintroduction regimen for chemotherapy according to criteria
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Cancer Hospital
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
- Investigators
- Weijian Guo, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485027
- Sponsor's protocol ID
- FDZL-RC
- Status last verified
- Dec 2023
- First submitted
- 26 Mar 2018
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Prior Regimen Rechallenge in Third or Later-line Chemotherapy for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03485027
- Acronym / sponsor ID
- FDZL-RC
- Conditions
- Metastatic Colorectal Cancer, Chemotherapy Effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Henan Cancer Hospital
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 2 Apr 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 is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in previous treatment and could not receive the target therapy presently are planned for recruitment. For patients with metastatic colorectal cancer who met admission criteria, oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated every 6 weeks. The treatment continues until the disease progression or the untolerable adverse reaction.
Detailed description
The treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen.
Optional chemotherapy regimen included XELOX,FOLFOX,FOLFIRI,Irinotecan single-agent
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- investigator chose the optimal reintroduction regimen for chemotherapy according to criteria
| Arm | Type | Receives |
|---|---|---|
| The rechallenge regimens | Experimental | Drug: the rechallenge regimenXELOX ± BEV, repeating every 3 weeks. FOLFOX ± BEV, repeating every 2 week FOLFOX ± Cetuximab, repeating every 2 week FOLFIRI ± BEV, repeating every 2 weeks. FOLFIRI ± Cetuximab, repeating every 2 weeks. IRI ± BEV, repeating every 2 weeks. IRI ± Cetuximab, repeating every 2 weeks. Raltitrexed ± BEV, repeating every 3 weeks. Raltitrexed ± Cetuximab, repeating every 2 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients age between 18 and 80 years
- Histologically confirmed metastatic colorectal cancer (mCRC)
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Treatment failure to at least two lines of chemotherapy (regimens should include oxaliplatin, fluorouracil and irinotecan); progression free survival (PFS) of prior oxaliplatin or irinotecan-based chemotherapy should be at least four months without any unrecoverable toxicity. Prior target therapy was acceptable
- For those who received other anti-tumor treatment, the toxicity should have been restored, with the time interval from last dose of cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥3 weeks
Key exclusion criteria (8 listed)
- Receiving other systemic anti-cancer treatment within 3 weeks
- Prior radiation therapy of target measurable lesion
- Presence of Grade III or IV chemo-related toxicity in previous treatment without recovery to Grade II or less
- With other malignant tumor in 5 years; except for cured cervical carcinoma in situ or basal cell carcinoma
- Symptomatic intracranial or meningeal metastasis
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 |
|---|---|---|
| the rechallenge regimenAlso: reintroduction of the former regimens in the third or later line treatment even after the same treatment had shown drug-resistance in the former settingXELOX regimen: Oxaliplatin 130mg/m2, intravenous, on day 1; Capecitabine 1000mg/m2, oral, twice daily, continuously for 14 days; ±bevacizumab 7.5mg/kg, intravenous, on day 1; repeating every 3 weeks. FOLFOX regimen: Oxaliplatin 85mg/m2 on day 1; Calcium folinate 400mg/m2 on day 1; 5-FU 400mg/m2 on day 1; 5-FU 2.4g/m2, continuous intravenous infusion for 46 hours, ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. FOLFIRI regimen: Irinotecan 180mg/m2 on day 1; Calcium folinate 400mg/m2 on day 1; 5-FU 400mg/m2 on day 1; 5-FU 2.4g/m2, continuous intravenous infusion for 46 hours; ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. Irinotecan monotherapy regimen: Irinotecan 180mg/m2 on day 1, ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. Raltitrexed contained regimen: Raltitrexed 3mg/m2 on day 1; ± Bevacizumab 7.5mg/kg, repeating every 3 weeks; Raltitrexed 2mg/m2 on day 1; ± Cetuximab 500mg/m2, repeating every 2 weeks. | Drug | The rechallenge regimens |
Primary outcome
PFS
Time frame: from the time signing of informed consent form(ICF) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
progression free survival
1 secondary outcome
OS
Time frame: from the time signing of ICF until the date of death from any cause, assessed up to 48 months
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 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Weijian Guo, M.D principal investigator
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 the rechallenge regimen in people with Metastatic Colorectal Cancer and Chemotherapy Effect, 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 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: finished, as of the sponsor's last update on 8 Dec 2023. 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?
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?
PFS (time frame: from the time signing of informed consent form(ICF) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months). 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 8 Dec 2023.