Colorectal CancerPhase 3C-CLASSICNCT04262635
Cetuximab Plus Capecitabine as Maintenance Treatment in RAS and BRAF wt Metastatic Colorectal Cancer
A Phase 3 study testing Cetuximab, Capecitabine and Cetuximab in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is an open-label, multicenter, randomized study to be conducted in Chinese patients with RAS and BRAF wild-type mCRC. Patients who have already completed 9 cycles of standard first-line induction treatment, without discontinuation for toxicity, of cetuximab or fluorouracil or oxaliplatin,, and achieved disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cetuximab, Capecitabine and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2021to 30 Aug 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to performance of any study procedure.
- Patient must be ≥18 years of age, at the time of signing the informed consent.
- Patients who have histologically or cytologically confirmed adenocarcinoma of the colon or rectum, excluding appendix carcinoma or anal canal carcinoma, with RAS and BRAF wild-type mutation status.
- Patients who received only FOLFOX plus cetuximab as first-line induction treatment after diagnosis of mCRC.
- Having completed FOLFOX plus cetuximab for 9 cycles as induction treatment (in the first cycle, they could be treated with FOLFOX alone for waiting the results of genetic test) without discontinuation for toxicity, of cetuximab or fluorouracil or oxaliplatin and achieved disease control (including CR/PR and SD) and are progression free at the start of maintenance therapy.
- At least one lesion(s), which is considered as unresectable at start of maintenance therapy (mCRC patients with resectable lesion(s) after induction treatment can be enrolled if they are willing to choose maintenance therapy). Patients who achieved CR and had no measurable lesion after induction treatment can be enrolled in this study.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy of at least 12 weeks in the opinion of the investigator.
- Laboratory requirements
- Neutrophils ≥1.5×109/L, platelets ≥75×109/L, and hemoglobin ≥9 g/dL;
- Total bilirubin ≤1.5×upper limit of normal (ULN); aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT)
- 2.5×ULN (≤5×ULN in case of liver metastases); alkaline phosphatase
- 2.5×ULN (≤5×ULN in case of liver metastases, ≤10×ULN in case of bone metastases); lactate dehydrogenase (LDH) <1500 U/L;
- Creatinine clearance (calculated according to Cockcroft and Gault) >60 mL/min or serum creatinine ≤1.5×ULN.
Who cannot join
- Having received chemotherapy for mCRC other than induction therapy with FOLFOX plus cetuximab, except for adjuvant therapy that has ended >9 months (oxaliplatin- based chemotherapy) or >6 months (oxaliplatin-free chemotherapy), prior to the start of the induction treatment.
- Other concurrently active malignancies, excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment. Patients who are definitely detected as dMMR/MSI-H at the start of induction therapy.
- Known brain metastasis or leptomeningeal metastasis. Patients with neurological symptoms should undergo brain computed tomography (CT)/ magnetic resonance imaging (MRI) to exclude metastases.
- Unresolved toxicity greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation). Patients with platinum induced neurotoxicity greater than or equal to CTCAE Grade 3 should be excluded.
- Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
- Intestinal obstruction, major gastrointestinal hemorrhage or other diseases not suitable for maintenance treatment in this study as assessed by the investigator within 2 weeks prior to enrollment.
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- Diabetes and hypertension as assessed by the investigator as not eligible for the subsequent maintenance treatment in this study.
- Myocardial infarction within the last 12 months, severe/unstable angina, symptoms of class III or IV congestive heart failure per New York Heart Association (NYHA) classification.
- Previous hypersensitivity to any of the study drugs (cetuximab or capecitabine).
- Deficiency in dihydropyrimidine dehydrogenase (DPD) as manifested by known medical history of fluorouracil adverse reactions.
- Known infection with human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS)-related illness, or active hepatitis B (positive HBsAg and HBV-DNA ≥ 2000 IU/mL or 104 copies/mL) or hepatitis C. Patients with previously confirmed COVID-19 infection, including severe, mild, asymptomatic, and recovered patients.
- Patients with active autoimmune disorders requiring treatment or history of organ transplantation requiring immunosuppressive therapy.
- Psychiatric disease that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results.
- Treatment with any of the following within the specified time frame prior to study drug administration
- Major surgery within 4 weeks (excluding diagnostic biopsy, the surgical incision should be fully healed prior to study drug administration);
- Radiotherapy within 4 weeks;
- Anti-cancer therapy other than protocol-specified induction therapy or participation in other clinical studies within 4 weeks.
- Anti-tumor traditional Chinese medicine within 2 weeks (such as Cantharidin, Cinobufacini).
- Pregnant (as determined by serum human chorionic gonadotropin [hCG] test) or lactating female, or female planning to become pregnant during treatment and for 2 months after the end of treatment with cetuximab and 6 months after the end of capecitabine. Woman of childbearing potential (WOCBP) with either positive or no pregnancy test at baseline. WOCBP or sexually active men not willing to use contraception during study and for at least 3 months after completion of cetuximab and 6 months after completion of capecitabine. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Presence of other serious disease or social circumstances that precludes patient enrollment in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multicenter, Open-label, Randomized Study to Assess the Efficacy and Safety of Cetuximab Plus Capecitabine Versus Cetuximab as Maintenance Treatment Following First-line Induction Treatment With FOLFOX and Cetuximab in Chinese Patients With RAS and BRAF Wild-type Metastatic Colorectal Cancer
This is an open-label, multicenter, randomized study to be conducted in Chinese patients with RAS and BRAF wild-type mCRC. Patients who have already completed 9 cycles of standard first-line induction treatment, without discontinuation for toxicity, of cetuximab or fluorouracil or oxaliplatin,, and achieved disease control (including CR/PR and SD), and are progression free at the end of Cycle 9 will be assigned to 2 maintenance treatment groups by randomization in a 1:1 ratio to receive cetuximab + capecitabine (Arm A) or cetuximab alone (Arm B). The randomization will be stratified by induction treatment response (complete response [CR]+ partial response [PR] versus stable disease [SD]) and primary tumor location (left side only versus right side). All patients from Arm A and Arm B will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal (whichever occurs earlier).
Read the detailed description
Coz COVID-19 limited, C-CLASSIC was terminated recruitment on 31Dec2022. Total screen 100 subjects and enroll 80 subjects. All subjects in study will be treatment until meet study endpoint. Then study related subject follow up, data collect, clinical study report will be continued as planned.
- Conditions
- Colorectal Cancer
- Being tested
- Cetuximab, Capecitabine, Cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab, CapecitabineDrug
Maintenance treatment ( ArmA )
CetuximabDrug
Maintenance treatment ( ArmB )
| Study group | Role | What they receive |
|---|---|---|
| ArmA Cetuximab plus Capecitabine | Experimental | Maintenance therapy with Cetuximab as intravenous (IV) infusion at the dose of 500 mg/m2, given every 2 weeks (Q2W); plus capecitabine in 2-week cycles until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal Receives: Drug: Cetuximab, Capecitabine |
| ArmB Cetuximab | Active comparator | Maintenance therapy with Cetuximab as intravenous (IV) infusion at the dose of 500 mg/m2, given every 2 weeks (Q2W) until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Maintenance PFS
mPFS from randomization to PD or death from any cause
Measured: From Baseline to primary completion date, about 42 months
Secondary outcomes (5)
Number of Participants With Adverse Events During Treatment Period
AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: From Baseline to primary completion date, about 42 months
Number of Participants With Clinical Laboratory Abnormalities During Treatment Period
Clinical laboratory tests include hematology, electrolyte and clinical chemistry.
Measured: From Baseline to primary completion date, about 42 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.
Measured: From Baseline to primary completion date, about 42 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29 (EORTC QLQ-CR29)
Quality of life in patients with colorectal cancer is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CR29. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.
Measured: From Baseline to primary completion date, about 42 months
Overall Survival
Time from randomization to death from any cause
Measured: From Baseline to primary completion date, about 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start24 Sep 2021
- Primary completion31 Dec 2022
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
- Investigators
- Ruihua Xu, MD, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262635
- Sponsor's protocol ID
- C-CLASSIC
- Acronym
- C-CLASSIC
- Status last verified
- Jul 2023
- First submitted
- 5 Feb 2020
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Open-label, Randomized Study to Assess the Efficacy and Safety of Cetuximab Plus Capecitabine Versus Cetuximab as Maintenance Treatment Following First-line Induction Treatment With FOLFOX and Cetuximab in Chinese Patients With RAS and BRAF Wild-type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04262635
- Acronym / sponsor ID
- C-CLASSIC / C-CLASSIC
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 10 Feb 2020 (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 an open-label, multicenter, randomized study to be conducted in Chinese patients with RAS and BRAF wild-type mCRC. Patients who have already completed 9 cycles of standard first-line induction treatment, without discontinuation for toxicity, of cetuximab or fluorouracil or oxaliplatin,, and achieved disease control (including CR/PR and SD), and are progression free at the end of Cycle 9 will be assigned to 2 maintenance treatment groups by randomization in a 1:1 ratio to receive cetuximab + capecitabine (Arm A) or cetuximab alone (Arm B). The randomization will be stratified by induction treatment response (complete response [CR]+ partial response [PR] versus stable disease [SD]) and primary tumor location (left side only versus right side). All patients from Arm A and Arm B will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal (whichever occurs earlier).
Detailed description
Coz COVID-19 limited, C-CLASSIC was terminated recruitment on 31Dec2022. Total screen 100 subjects and enroll 80 subjects. All subjects in study will be treatment until meet study endpoint. Then study related subject follow up, data collect, clinical study report will be continued as planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ArmA Cetuximab plus Capecitabine | Experimental | Drug: Cetuximab, CapecitabineMaintenance therapy with Cetuximab as intravenous (IV) infusion at the dose of 500 mg/m2, given every 2 weeks (Q2W); plus capecitabine in 2-week cycles until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal |
| ArmB Cetuximab | Active comparator | Drug: CetuximabMaintenance therapy with Cetuximab as intravenous (IV) infusion at the dose of 500 mg/m2, given every 2 weeks (Q2W) until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent prior to performance of any study procedure.
- Patient must be ≥18 years of age, at the time of signing the informed consent.
- Patients who have histologically or cytologically confirmed adenocarcinoma of the colon or rectum, excluding appendix carcinoma or anal canal carcinoma, with RAS and BRAF wild-type mutation status.
- Patients who received only FOLFOX plus cetuximab as first-line induction treatment after diagnosis of mCRC.
- Having completed FOLFOX plus cetuximab for 9 cycles as induction treatment (in the first cycle, they could be treated with FOLFOX alone for waiting the results of genetic test) without discontinuation for toxicity, of cetuximab or fluorouracil or oxaliplatin and achieved disease control (including CR/PR and SD) and are progression free at the start of maintenance therapy.
Key exclusion criteria (20 listed)
- Having received chemotherapy for mCRC other than induction therapy with FOLFOX plus cetuximab, except for adjuvant therapy that has ended >9 months (oxaliplatin- based chemotherapy) or >6 months (oxaliplatin-free chemotherapy), prior to the start of the induction treatment.
- Other concurrently active malignancies, excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment. Patients who are definitely detected as dMMR/MSI-H at the start of induction therapy.
- Known brain metastasis or leptomeningeal metastasis. Patients with neurological symptoms should undergo brain computed tomography (CT)/ magnetic resonance imaging (MRI) to exclude metastases.
- Unresolved toxicity greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation). Patients with platinum induced neurotoxicity greater than or equal to CTCAE Grade 3 should be excluded.
- Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
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 |
|---|---|---|
| Cetuximab, CapecitabineMaintenance treatment ( ArmA ) | Drug | ArmA Cetuximab plus Capecitabine |
| CetuximabMaintenance treatment ( ArmB ) | Drug | ArmB Cetuximab |
Primary outcome
Efficacy: Maintenance PFS
Time frame: From Baseline to primary completion date, about 42 months
mPFS from randomization to PD or death from any cause
5 secondary outcomes
Number of Participants With Adverse Events During Treatment Period
Time frame: From Baseline to primary completion date, about 42 months
Number of Participants With Clinical Laboratory Abnormalities During Treatment Period
Time frame: From Baseline to primary completion date, about 42 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Time frame: From Baseline to primary completion date, about 42 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29 (EORTC QLQ-CR29)
Time frame: From Baseline to primary completion date, about 42 months
Overall Survival
Time frame: From Baseline to primary completion date, about 42 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Ruihua Xu, MD study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetuximab, Capecitabine and Cetuximab in people with Colorectal Cancer, run by Sun Yat-sen 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 14 inclusion and 20 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 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Efficacy: Maintenance PFS (time frame: From Baseline to primary completion date, about 42 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 2 Aug 2023.