Colorectal CancerPhase 3RAMTASNCT03520946
RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer Patients
A Phase 3 study testing Ramucirumab and TAS 102 in people with Colorectal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 28 sites in Germany.
Trial summary
Interventional, prospective, randomized (1:1), controlled, open label, multicenter phase IIb study in patients with advanced metastatic colorectal cancer. The scope of the trial is to evaluate overall survival of either regimen (TAS102 +/- Ramucirumab) and evaluate safety and tolerability. 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?
- Ramucirumab and TAS 102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 28 sitesGermany
- Study dates
- 24 Jan 2019to 30 Jul 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
- Metastatic and inoperable, colorectal cancer who has progressed on/after, or did not tolerate, refuse or have contraindications to: fluoropyrimidines, oxaliplatin, irinotecan, anti-angiogenic therapies (bevacizumab, aflibercept, regorafenib or ramucirumab) and if indicated anti-EGFR antibodies (cetuximab or panitumumab).
- Intolerance is defined as a permanent discontinuation of the respective treatment resulting from toxicity
- Signed informed consent before start of specific protocol procedure
- Histologically or cytologically documented diagnosis of adenocarcinoma of the colon or rectum
- Presence of at least one measurable site of disease following RECIST 1.1 criteria
- ECOG (Eastern Cooperative Oncology Group) performance 0-1
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- Known RAS and BRAF V600E mutational status
- Life expectancy of at least 3 months
- Adequate hematological, hepatic and renal function parameters:
- Leukocytes ≥3000/mm³, platelets ≥100,000/mm³, neutrophil count (ANC) ≥1500/μL, hemoglobin ≥9 g/dL (5.58 mmol/L)
- Adequate coagulation function as defined by International Normalized Ratio (INR) ≤1.5, and a partial thromboplastin time (PTT) ≤5 seconds above the ULN (upper limit of normal) (unless receiving anticoagulation therapy). Patients receiving warfarin/phenprocoumon must be switched to low molecular weight heparin and have achieved a stable coagulation profile prior to first dose of protocol therapy
- Serum creatinine ≤1.5 x upper limit of normal or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed)
- Urinary protein ≤1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥2+, a 24-hour urine collection for protein must demonstrate <1000 mg of protein in 24 hours to allow participation in this protocol)
- Bilirubin ≤1.5 x upper limit of normal, AST and ALT ≤3.0 x upper limit of normal, ≤5xULN if liver metastasis present, alkaline phosphatase ≤6 x upper limit of normal
- Patient able and willing to provide written informed consent and to comply with the study protocol
- Female and male patients ≥18. Patients in reproductive age must be willing to use adequate contraception during the study and for 7 months after the end of ramucirumab treatment (appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy) or hormonal contraception (implantable, patch, oral). Women who use a hormonal contraception method should use an additional barrier method like IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start (There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently.)
Who cannot join
- Known hypersensitivity against ramucirumab or TAS102
- Other known contraindications against ramucirumab, TAS102, or other anti-angiogenic therapies
- Prior therapy with TAS102
- Drug-related severe adverse events upon pretreatment with antiangiogenic drugs that would require permanent discontinuation and not allow re-challenge with the same class of drug (i.e. ramucirumab) such as noncontrollable severe hypertension or thromboembolic events
- Any antineoplastic treatment including irradiation within 14 days (42 days for mitomycin c) prior to start of therapy.
- Major surgery within 4 weeks of starting therapy within this study, or minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial.
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- Symptomatic brain metastasis
- Clinically significant cardiovascular disease
- NYHA>II°, myocardial infarction within 6 months prior study entry
- Known clinically significant valvular defect
- Uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or >100 mmHg diastolic for >4 weeks) despite standard medical management
- Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy
- History of deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to first dose of protocol therapy
- Active clinically serious infections (> grade 2 NCI-CTC version 4.0)
- Chronic inflammatory bowel disease
- History of uncontrolled HIV infection or chronic hepatitis B or C
- Patients with evidence of bleeding diathesis
- Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy
- Receiving chronic antiplatelet therapy, including aspirin (once daily aspirin use (maximum dose 325 mg/day) is permitted), nonsteroidal anti-inflammatory drugs (including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents
- History of gastrointestinal perforation or fistulae in past 6 months or risk factors for perforation
- Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy
- Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix or bladder, or low/intermediate risk prostate cancer (Gleason score ≤7) with normal PSA levels
- Any condition that could jeopardize the safety of the patient and their compliance of the study
- Medical, psychological or social conditions that may interfere with the participation in the study
- Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites.
- Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
- On-treatment participation in another clinical study or received investigational drug therapy in the period 30 days prior to inclusion and during the study
- Subject pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
- Patients in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)
- Any other concurrent antineoplastic treatment including irradiation
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Germany28 sites
MVZ Gesundheitszentrum St. Marien GmbH
Amberg, 922241
HELIOS Klinikum Bad Saarow
Bad Saarow, 15526
Charité - Universitätsmedizin Berlin Campus Mitte
Berlin, 10115
MVZ Seestrasse
Berlin, 13347
St.-Johannes-Hospital
Dortmund, 44137
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Universitätsklinikum Essen
Essen, 45147
Krankenhaus Nordwest GmbH
Frankfurt, 60488
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Asklepios Klinik Hamburg Barmbek
Hamburg, 22307
Medizinische Hochschule Hannover
Hanover, 30625
Marien Hospital Herne
Herne, 44625
Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, 76137
Universitätsklinikum Leipzig
Leipzig, 04103
Klinikum Ludwigsburg
Ludwigsburg, 71640
Tagestherapiezentrum am ITM Universitätsmedizin Mannheim
Mannheim, 68167
Johannes Wesling Klinikum Minden
Minden, 32429
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063
Klinikum der Universität München-Großhadern
München, 81377
Unversitätsklinikum Münster
Münster, 48149
Klinikum Nürnberg
Nuremberg, 90419
Studienzentrum Onkologie Ravensburg
Ravensburg, 88212
MedCenter Nordsachsen
Schkeuditz, 04435
Leopoldina Krankenhaus
Schweinfurt, 97422
MVZ Klinik Dr. Hancken GmbH
Stade, 21680
Universitätsklinikum Ulm
Ulm, 89081
Klinikum Wilhelmshaven
Wilhelmshaven, 26389
Hämatologisch-Onkologische Praxis
Würselen, 52146
About this study
Official title: A Phase III Study of RAMucirumab in Combination With TAS102 vs. TAS102 Monotherapy in Chemotherapy Refractory Metastatic Colorectal Cancer Patients
Interventional, prospective, randomized (1:1), controlled, open label, multicenter phase IIb study in patients with advanced metastatic colorectal cancer. The scope of the trial is to evaluate overall survival of either regimen (TAS102 +/- Ramucirumab) and evaluate safety and tolerability.
Read the detailed description
This is an interventional, prospective, randomized (1:1), controlled, open label, multicenter phase IIb study in patients with advanced metastatic colorectal cancer. The scope of the trial is to evaluate overall survival of either regimen and evaluate safety and tolerability.
Patients with advanced metastatic and inoperable, colorectal cancer who have progressed on/after or did not tolerate: fluoropyrimidines, oxaliplatin, irinotecan, anti-angiogenic therapies (bevacizumab, aflibercept, regorafenib or ramucirumab) and when indicated anti-EGFR (epidermal growth factor receptor) antibodies (cetuximab or panitumumab) will be included in this trial.
Patients will be stratified by the duration of previous anti-angiogenic therapy ≥ or <12 months in total, BRAF V600E mutation status (mutation vs. wildtype), RAS mutation status (mutation vs. wildtype), and randomized 1:1 to receive either ramucirumab/TAS102 (arm A) or TAS102 (arm B). Concurrent use of other chemotherapy is not allowed.
Two interim safety analyses will be conducted when 10 and 40 patients are fully documented in arm A after receiving 2 cycles (one 4-week cycle comprises ramucirumab 8mg/kg administered at d1 and d15 and TAS102 35mg/m2 p.o. twice daily administered on d1-5 and d8-12). The analysis will be reviewed by the lead coordinating investigator (Prof. Dr. Kasper) and members of the steering committee and then by the data safety monitoring board. It is not planned to discontinue recruitment for the interim safety analyses.
Arm A (ramucirumab/TAS102) Patients randomized to arm A will receive ramucirumab 8 mg/kg iv over 60 min on d1+15, q4w and TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression or intolerance or completion of 6 cycles.
Arm B (TAS102) Patients randomized to arm B will receive TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression, intolerance or completion of 6 cycles.
In both arms, tumor assessments (CT or MRI) are performed before enrollment/randomization and then every 8 weeks (every 2nd cycle) during therapy and every 12 weeks during follow-up until progression/relapse, death or end of follow-up. A change from CT into MRI in the follow-up period is possible at any time.
During treatment, clinical visits (blood cell counts, detection of toxicity) will be performed prior to every treatment dose of ramucirumab or every two weeks in arm B or if ramucirumab was discontinued in arm A. Safety of TAS102 +/- ramucirumab will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported. Every 4 weeks during therapy Quality of life (QoL) will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and the EuroQol 5 dimensions 5-level version (EQ-5D-5L).
- Conditions
- Colorectal Cancer
- Being tested
- Ramucirumab, TAS 102
- Keywords
- colorectal cancer, ramucirumab, tas102
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabDrug
8 mg/kg iv over 60 min on d1+15, q4w
TAS 102Drug
35mg/m2 p.o. twice daily (BID) d1-5 and d8-12, q4w
| Study group | Role | What they receive |
|---|---|---|
| Arm A (ramucirumab + TAS102) | Experimental | Patients randomized to arm A will receive ramucirumab 8 mg/kg iv over 60 min on d1+15, q4w and TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression or intolerance or completion of 6 cycles. Receives: Drug: Ramucirumab; Drug: TAS 102 |
| Arm B (TAS102 only) | Active comparator | Patients randomized to arm B will receive TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression, intolerance or completion of 6 cycles. Receives: Drug: TAS 102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival according to Kaplan-Meier
Measured: Up to 4 years
Secondary outcomes (9)
Overall response rate (ORR)
ORR defined as the proportion of patients with complete or partial remission according to RECIST 1.1
Measured: Up to 4 years
Disease control rate (DCR)
DCR defined as the proportion of patients with complete or partial remission and stable disease according to RECIST 1.1
Measured: Up to 4 years
Progression-free survival (PFS)
PFS, defined as the time from enrollment/randomization to the first occurrence of progression, as determined by the investigator using CT criteria, or death from any cause
Measured: Up to 4 years
Overall survival (OS) rate at different time points
OS rate at 6 and 12 months, defined as patients who are alive after at 6 and 12 months, respectively
Measured: 6 months and 1 year
Efficacy (ORR) subgroup
Efficacy (ORR) in patients who develop neutropenia grade ≥2 (ANC ≤1500/μl) in cycle 1
Measured: Up to 4 years
Efficacy (PFS) subgroup
Efficacy (PFS) in patients who develop neutropenia grade ≥2 (ANC ≤1500/μl) in cycle 1
Measured: Up to 4 years
Efficacy (OS) subgroup
Efficacy (OS) in patients who develop neutropenia grade ≥2 (ANC ≤1500/μl) in cycle 1
Measured: Up to 4 years
Quality of life I (QoL)
Quality of life (QoL) as measured by EORTC-QLQ-C30 at d1 of each cycle and on EOT (end of treatment).
Measured: Up to 1 year
Quality of life II (QoL)
Quality of life (QoL) as measured by EQ-5D-5L at d1 of each cycle and on EOT.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start24 Jan 2019
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
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
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Trium Analysis Online GmbH
- Responsible party
- Sponsor
- Investigators
- Salah-Eddin Al-Batran, Prof. Dr., Study chair, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520946
- Sponsor's protocol ID
- RAMTAS
- Other IDs
- 2017-004162-99, 2017
- Acronym
- RAMTAS
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2018
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of RAMucirumab in Combination With TAS102 vs. TAS102 Monotherapy in Chemotherapy Refractory Metastatic Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT03520946
- Acronym / sponsor ID
- RAMTAS / RAMTAS
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, ramucirumab, tas102
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Trium Analysis Online GmbH
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 11 May 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.
Interventional, prospective, randomized (1:1), controlled, open label, multicenter phase IIb study in patients with advanced metastatic colorectal cancer. The scope of the trial is to evaluate overall survival of either regimen (TAS102 +/- Ramucirumab) and evaluate safety and tolerability.
Detailed description
This is an interventional, prospective, randomized (1:1), controlled, open label, multicenter phase IIb study in patients with advanced metastatic colorectal cancer. The scope of the trial is to evaluate overall survival of either regimen and evaluate safety and tolerability.
Patients with advanced metastatic and inoperable, colorectal cancer who have progressed on/after or did not tolerate: fluoropyrimidines, oxaliplatin, irinotecan, anti-angiogenic therapies (bevacizumab, aflibercept, regorafenib or ramucirumab) and when indicated anti-EGFR (epidermal growth factor receptor) antibodies (cetuximab or panitumumab) will be included in this trial.
Patients will be stratified by the duration of previous anti-angiogenic therapy ≥ or <12 months in total, BRAF V600E mutation status (mutation vs. wildtype), RAS mutation status (mutation vs. wildtype), and randomized 1:1 to receive either ramucirumab/TAS102 (arm A) or TAS102 (arm B). Concurrent use of other chemotherapy is not allowed.
Two interim safety analyses will be conducted when 10 and 40 patients are fully documented in arm A after receiving 2 cycles (one 4-week cycle comprises ramucirumab 8mg/kg administered at d1 and d15 and TAS102 35mg/m2 p.o. twice daily administered on d1-5 and d8-12). The analysis will be reviewed by the lead coordinating investigator (Prof. Dr. Kasper) and members of the steering committee and then by the data safety monitoring board. It is not planned to discontinue recruitment for the interim safety analyses.
Arm A (ramucirumab/TAS102) Patients randomized to arm A will receive ramucirumab 8 mg/kg iv over 60 min on d1+15, q4w and TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression or intolerance or completion of 6 cycles.
Arm B (TAS102) Patients randomized to arm B will receive TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression, intolerance or completion of 6 cycles.
In both arms, tumor assessments (CT or MRI) are performed before enrollment/randomization and then every 8 weeks (every 2nd cycle) during therapy and every 12 weeks during follow-up until progression/relapse, death or end of follow-up. A change from CT into MRI in the follow-up period is possible at any time.
During treatment, clinical visits (blood cell counts, detection of toxicity) will be performed prior to every treatment dose of ramucirumab or every two weeks in arm B or if ramucirumab was discontinued in arm A. Safety of TAS102 +/- ramucirumab will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported. Every 4 weeks during therapy Quality of life (QoL) will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and the EuroQol 5 dimensions 5-level version (EQ-5D-5L).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (ramucirumab + TAS102) | Experimental | Drug: Ramucirumab, Drug: TAS 102Patients randomized to arm A will receive ramucirumab 8 mg/kg iv over 60 min on d1+15, q4w and TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression or intolerance or completion of 6 cycles. |
| Arm B (TAS102 only) | Active comparator | Drug: TAS 102Patients randomized to arm B will receive TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression, intolerance or completion of 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Metastatic and inoperable, colorectal cancer who has progressed on/after, or did not tolerate, refuse or have contraindications to: fluoropyrimidines, oxaliplatin, irinotecan, anti-angiogenic therapies (bevacizumab, aflibercept, regorafenib or ramucirumab) and if indicated anti-EGFR antibodies (cetuximab or panitumumab).
- Intolerance is defined as a permanent discontinuation of the respective treatment resulting from toxicity
- Signed informed consent before start of specific protocol procedure
- Histologically or cytologically documented diagnosis of adenocarcinoma of the colon or rectum
- Presence of at least one measurable site of disease following RECIST 1.1 criteria
Key exclusion criteria (30 listed)
- Known hypersensitivity against ramucirumab or TAS102
- Other known contraindications against ramucirumab, TAS102, or other anti-angiogenic therapies
- Prior therapy with TAS102
- Drug-related severe adverse events upon pretreatment with antiangiogenic drugs that would require permanent discontinuation and not allow re-challenge with the same class of drug (i.e. ramucirumab) such as noncontrollable severe hypertension or thromboembolic events
- Any antineoplastic treatment including irradiation within 14 days (42 days for mitomycin c) prior to start of therapy.
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 |
|---|---|---|
| Ramucirumab8 mg/kg iv over 60 min on d1+15, q4w | Drug | Arm A (ramucirumab + TAS102) |
| TAS 10235mg/m2 p.o. twice daily (BID) d1-5 and d8-12, q4w | Drug | Arm A (ramucirumab + TAS102), Arm B (TAS102 only) |
Primary outcome
Overall survival
Time frame: Up to 4 years
Overall survival according to Kaplan-Meier
9 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 4 years
Disease control rate (DCR)
Time frame: Up to 4 years
Progression-free survival (PFS)
Time frame: Up to 4 years
Overall survival (OS) rate at different time points
Time frame: 6 months and 1 year
Efficacy (ORR) subgroup
Time frame: Up to 4 years
Efficacy (PFS) subgroup
Time frame: Up to 4 years
Efficacy (OS) subgroup
Time frame: Up to 4 years
Quality of life I (QoL)
Time frame: Up to 1 year
Quality of life II (QoL)
Time frame: Up to 1 year
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 9 Aug 2024.
- Individual participant dataSharing planned: No. No IPD will be shared
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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.
Salah-Eddin Al-Batran, Prof. Dr. study chair
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramucirumab and TAS 102 in people with Colorectal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 28 sites in Germany.
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 16 inclusion and 30 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany. 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?
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?
Overall survival (time frame: Up to 4 years). 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 9 Aug 2024.