Colorectal CancerPhase 3CR-SEQUENCENCT03635021
Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer
A Phase 3 study testing FOLFOX regimen, Panitumumab and Bevacizumab in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
Trial summary
The purpose of this study is to assess the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX + bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in untreated patients with wild-type RAS metastatic, primary left-sided, unresectable colorectal cancer 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?
- FOLFOX regimen, Panitumumab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2018to 28 Jun 2025
- 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
- Man or woman at least 18 years old.
- Capable of understand, sign and date an informed consent approved by an IEC.
- Histologically confirmed adenocarcinoma of the left colon or rectum (originate in the splenic flexure, descending colon, sigmoid colon, or rectum) in patients with unresectable (not amenable to radical surgery of metastases at the study inclusion) metastatic (M1) disease.
- Patients who had wild-type RAS status confirmed as per standard of care according to international guidelines prior to first-line initiation.
- RAS analysis should include at least KRAS exons 2, 3 and 4 (codons 12, 13, 59, 61, 117 and 146) and NRAS exons 2, 3 and 4 (codons 12, 13, 59, 61 and 117)
- At least one unidimensionally measurable lesion per RECIST criteria (version 1.1).
Show all 11Show fewer
- ECOG performance status < 2.
- Adequate bone marrow function: neutrophils ≥1.5 x109 / L; platelets ≥100 x109 /L; haemoglobin ≥ 9 g/dL.
- Hepatic, renal and metabolic function as follows:
- Total bilirubin count ≤1.5 x upper limit of normal (ULN), serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) and serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) ≤ 2.5 x ULN (5 x ULN for subjects with liver involvement of their cancer or 10 x ULN for subjects with bone involvement).
- Renal function, calculated as creatinine clearance or 24-hour creatinine clearance ≥ 50 mL/min.
Who cannot join
- History of prior or concurrent central nervous system metastases.
- History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization.
- Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma.
- Prior adjuvant chemotherapy for colorectal cancer (stage I, II or III) terminated less than 6 month before metastatic disease was diagnosed.
- Unresolved toxicities of a previous systemic treatment that, in the opinion of the Investigator, cause the patient unfit for inclusion.
- Prior use (as monotherapy or adjuvant treatment) of anti-EGFR antibody therapy (e.g. cetuximab), anti-VEGF or small molecule EGFR inhibitors (e.g. erlotinib).
Show all 28Show fewer
- Prior hormonal therapy, immunotherapy or approved or experimental antibody/proteins ≤ 30 days before inclusion.
- Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
- Uncontrolled hypertension.
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computerised tomography (CT).
- Treatment for systemic infection within 14 days before the start of study treatment.
- Acute or subacute intestinal occlusion and/or active inflammatory bowel disease or other bowel disease that causes chronic diarrhoea (defined as grade ≥ 2 diarrhoea according to NCI-CTCAE version 4.03).
- Clinically significant peripheral sensory neuropathy.
- Evidence of previous acute hypersensitivity reaction, of any grade, to any component of the treatment.
- History of Gilbert disease or known dihydropyrimidine deficiency syndrome.
- Recent (within 6 months before the start of study treatment) gastroduodenal ulcer to be active or uncontrolled.
- Recent (within 6 months before the start of study treatment) pulmonary embolism, deep vein thrombosis, or other significant venous event.
- Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy (within 6 months before the start of study treatment)
- Recent (within 4 weeks prior to inclusion in the study) major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery
- History of any disease that may increase the risks associated with study participation or may interfere with the interpretation of study results.
- Known positive test for human immunodeficiency virus infection, hepatitis C virus, and chronic active hepatitis B infection.
- Any disorder that compromises the patient's ability to provide written informed consent and/or comply with study procedures.
- Any investigational agent within 30 days prior to inclusion.
- Pregnant or breastfeeding woman.
- Surgery (excluding diagnostic biopsy or placement of a central venous catheter) and/or radiotherapy within 28 days prior to inclusion in the study.
- Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g. diaphragm plus condoms) or abstinence during the course of the study and for 6 months after the last administration of study drug for women and 1 month for men.
- The patient is unwilling or unable to meet the requirements of the study.
- Psychological, geographical, familial or sociological conditions that potentially prevent compliance with the study protocol and follow-up schedule.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Cooperative Group for the Treatment of Digestive Tumors
Madrid, 28007
About this study
Official title: Phase III Randomized Sequential Open-label Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer: The CR-SEQUENCE
The purpose of this study is to assess the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX + bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in untreated patients with wild-type RAS metastatic, primary left-sided, unresectable colorectal cancer
- Conditions
- Colorectal Cancer
- Being tested
- FOLFOX regimen, Panitumumab, Bevacizumab, FOLFIRI regimen
- Keywords
- colorectal cancer, FOLFOX, FOLFIRI, panitumumab, bevacizumab, wild-type RAS, primary left-sided
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
oxaliplatin 85 mg/m2 administered by IV infusion over 120 minutes on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46- 48 hours on Days 1 and 2
PanitumumabDrug
6 mg/kg administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 14-day cycle
BevacizumabDrug
5 mg/kg administered by IV infusion over 60 minutes on Day 1 of each 14-day cycle
FOLFIRI regimenDrug
irinotecan 180 mg/m2 administered as a 90 minutes IV infusion on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46-48 hours on Days 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | FOLFOX regimen panitumumab FOLFIRI regimen bevacizumab Receives: Drug: FOLFOX regimen; Drug: Panitumumab; Drug: Bevacizumab; Drug: FOLFIRI regimen |
| Sequence 2 | Experimental | FOLFOX regimen bevacizumab FOLFIRI regimen panitumumab Receives: Drug: FOLFOX regimen; Drug: Panitumumab; Drug: Bevacizumab; Drug: FOLFIRI regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate at 35 months
35-month PFSR defined as the number of patients, who at 35 months after randomization, have not had second or first disease progression nor died (due to any cause), over the total number of evaluable patients.
Measured: 35 months after date of randomization
Secondary outcomes (13)
overall survival rate at 35 months
35-month OSR defined as the number of patients who at 35 months after randomization have not died over the total number of evaluable patients.
Measured: 35 months after date of randomization
overall survival
OS defined as the time from randomization to the date of death (due to any cause), with patients alive or lost to follow-up at the analysis data cut-off date censored at their last contact date.
Measured: Baseline through the end of the study (up 72 months)
progression-free from randomization to second progression or death
Total PFS defined as the time from randomization to second disease progression (i.e. progression during the second-line treatment) or death (due to any cause).
Measured: Baseline through the end of the study (up 72 months)
progression-free survival in first-line treatment and in second-line treatment
PFS in first-line treatment defined as the time from randomization to disease progression or death (due to any cause) during first-line treatment. PFS in second-line treatment defined as the time from the date of second-line treatment initiation to disease progression or death (due to any cause) during secondline treatment.
Measured: Baseline through the end of the study (up 72 months)
time to first-line treatment failure and to second-line treatment failure
Time to first-line treatment failure defined as the time form randomization to disease progression, death (due to any cause) or discontinuation due to toxicity during first-line treatment. Time to second-line treatment failure defined as the time from the date of second-line treatment initiation to disease progression, death (due to any cause) or discontinuation due to toxicity during second-line treatment.
Measured: 72 months
objective response rate
Proportion of patients with an objective response (complete or partial response) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria in first-line treatment and in second-line treatment.
Measured: Baseline through the end of the study (up 72 months)
proportion of patients with Early Tumour Shrinkage
Proportion of patients with ETS in first-line treatment and in second-line treatment. ETS will be defined as a reduction in tumour size ≥30% (RECIST 1.1 criteria) at the first evaluation (i.e. week 12)
Measured: Baseline through the end of the study (up 72 months)
Depth of Response
DpR measured as the maximum decrease in target measurement (RECIST 1.1 criteria) during the complete course of evaluation in first-line treatment and in second-line treatment.
Measured: Baseline through the end of the study (up 72 months)
disease control rate
Proportion of patients with disease control (complete, partial response or stable disease) in first-line treatment and in second-line treatment.
Measured: Baseline through the end of the study (up 72 months)
duration of disease control
Duration of disease control defined as time from first confirmed disease control to disease progression per RECIST 1.1 criteria or death (due to any cause) in first-line treatment and in second-line treatment. For patients with disease control who have not progressed or died at last observation, duration of disease control will be censored at their last evaluable disease assessment date.
Measured: Baseline through the end of the study (up 72 months)
duration of response
Duration of response defined as time from first confirmed objective response to disease progression per RECIST 1.1 criteria or death (due to any cause) in first-line treatment and in second-line treatment. For patients with response who have not progressed or died at last observation, duration of response will be censored at their last evaluable disease assessment date.
Measured: Baseline through the end of the study (up 72 months)
time to response
Time to response in first-line treatment defined as the time from randomization to the date of first confirmed objective response per RECIST 1.1 criteria during first-line treatment.
Time to response in second-line treatment defined as the time from the date of second-line treatment initiation to the date of first confirmed objective response per RECIST 1.1 criteria during second-line treatment.
Measured: Baseline through the end of the study (up 72 months)
Incidence and severity of AEs CTCAE v4.03 criteria
Safety assessment will consist of monitoring adverse events (AEs), including AEs of special interest, serious AEs (SAEs) and laboratory safety parameters. AEs will be graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03.
Measured: Baseline through the end of the study (up 72 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Oct 2018
- Primary completion28 Jun 2025 (estimated)
- Study completion28 Jun 2025 (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.
- 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
- 419 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Ramón Salazar, MD, PhD, Study chair, Instituto Catalán de Oncología. Hospital Duran i ReynalsAlfredo Carrato, MD, PhD, Study chair, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635021
- Sponsor's protocol ID
- TTD-18-01
- Acronym
- CR-SEQUENCE
- Status last verified
- Oct 2024
- First submitted
- 9 Aug 2018
- Last updated
- 21 Oct 2024
- 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Sequential Open-label Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer: The CR-SEQUENCE
- ClinicalTrials.gov ID
- NCT03635021
- Acronym / sponsor ID
- CR-SEQUENCE / TTD-18-01
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, FOLFOX, FOLFIRI, panitumumab, bevacizumab, wild-type RAS, primary left-sided
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 419 participants (estimated)
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)University, hospital or other
- Collaborators
- Amgen
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 28 Jun 2025 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 17 Aug 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.
The purpose of this study is to assess the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX + bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in untreated patients with wild-type RAS metastatic, primary left-sided, unresectable colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: FOLFOX regimen, Drug: Panitumumab, Drug: Bevacizumab, Drug: FOLFIRI regimenFOLFOX regimen panitumumab FOLFIRI regimen bevacizumab |
| Sequence 2 | Experimental | Drug: FOLFOX regimen, Drug: Panitumumab, Drug: Bevacizumab, Drug: FOLFIRI regimenFOLFOX regimen bevacizumab FOLFIRI regimen panitumumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Man or woman at least 18 years old.
- Capable of understand, sign and date an informed consent approved by an IEC.
- Histologically confirmed adenocarcinoma of the left colon or rectum (originate in the splenic flexure, descending colon, sigmoid colon, or rectum) in patients with unresectable (not amenable to radical surgery of metastases at the study inclusion) metastatic (M1) disease.
- Patients who had wild-type RAS status confirmed as per standard of care according to international guidelines prior to first-line initiation.
- RAS analysis should include at least KRAS exons 2, 3 and 4 (codons 12, 13, 59, 61, 117 and 146) and NRAS exons 2, 3 and 4 (codons 12, 13, 59, 61 and 117)
Key exclusion criteria (28 listed)
- History of prior or concurrent central nervous system metastases.
- History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization.
- Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma.
- Prior adjuvant chemotherapy for colorectal cancer (stage I, II or III) terminated less than 6 month before metastatic disease was diagnosed.
- Unresolved toxicities of a previous systemic treatment that, in the opinion of the Investigator, cause the patient unfit for inclusion.
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 |
|---|---|---|
| FOLFOX regimenoxaliplatin 85 mg/m2 administered by IV infusion over 120 minutes on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46- 48 hours on Days 1 and 2 | Drug | Sequence 1, Sequence 2 |
| Panitumumab6 mg/kg administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 14-day cycle | Drug | Sequence 1, Sequence 2 |
| Bevacizumab5 mg/kg administered by IV infusion over 60 minutes on Day 1 of each 14-day cycle | Drug | Sequence 1, Sequence 2 |
| FOLFIRI regimenirinotecan 180 mg/m2 administered as a 90 minutes IV infusion on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46-48 hours on Days 1 and 2 | Drug | Sequence 1, Sequence 2 |
Primary outcome
Progression-free survival rate at 35 months
Time frame: 35 months after date of randomization
35-month PFSR defined as the number of patients, who at 35 months after randomization, have not had second or first disease progression nor died (due to any cause), over the total number of evaluable patients.
13 secondary outcomes
overall survival rate at 35 months
Time frame: 35 months after date of randomization
overall survival
Time frame: Baseline through the end of the study (up 72 months)
progression-free from randomization to second progression or death
Time frame: Baseline through the end of the study (up 72 months)
progression-free survival in first-line treatment and in second-line treatment
Time frame: Baseline through the end of the study (up 72 months)
time to first-line treatment failure and to second-line treatment failure
Time frame: 72 months
objective response rate
Time frame: Baseline through the end of the study (up 72 months)
proportion of patients with Early Tumour Shrinkage
Time frame: Baseline through the end of the study (up 72 months)
Depth of Response
Time frame: Baseline through the end of the study (up 72 months)
disease control rate
Time frame: Baseline through the end of the study (up 72 months)
duration of disease control
Time frame: Baseline through the end of the study (up 72 months)
duration of response
Time frame: Baseline through the end of the study (up 72 months)
time to response
Time frame: Baseline through the end of the study (up 72 months)
Incidence and severity of AEs CTCAE v4.03 criteria
Time frame: Baseline through the end of the study (up 72 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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.
Ramón Salazar, MD, PhD study chair
Instituto Catalán de Oncología. Hospital Duran i Reynals
Alfredo Carrato, MD, PhD study chair
Hospital Universitario Ramon y Cajal
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 FOLFOX regimen, Panitumumab and Bevacizumab in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
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 11 inclusion and 28 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 21 Oct 2024. 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 Spain. 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?
Progression-free survival rate at 35 months (time frame: 35 months after date of randomization). 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 21 Oct 2024.