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Colorectal Cancer MetastaticPhase 3STRATEGIC-1NCT01910610

Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer

A Phase 3 study testing FOLFIRI-cetuximab, mFOLFOX6-bevacizumab and OPTIMOX-bevacizumab in people with Colorectal Cancer Metastatic, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 56 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
FOLFIRI-cetuximab, mFOLFOX6-bevacizumab and OPTIMOX-bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
464 participants
Where
56 sitesin 3 countries
Study dates
30 Oct 2013to Dec 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

  • Signed and dated informed consent, and willing and able to comply with protocol requirements,
  • Histologically proven adenocarcinoma of the colon and/or rectum,
  • Wild-type RAS tumor no mutation in exon 2 [codon 12/13], exon 3 [codon 59/61] and exon 4 [codon 117/146] of both KRAS and NRAS genes (local assessment, performed either on primary tumor or metastasis), In exceptional circumstances, RAS mutational status (KRAS and NRAS) can be pending at time of randomization, provided it is obtained within the first two cycles of first line therapy
  • Metastatic disease confirmed,
  • No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >6 months for fluoropyrimidine alone or >12 months for oxaliplatin-based, bevacizumab-based, or cetuximab-based therapy),
  • Duly documented unresectable metastatic disease, ie not suitable for complete carcinological surgical resection at inclusion [NB: patients with unresectable disease at study entry but with any potential of salvage surgery after induction therapy are eligible],
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  • At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1,
  • Age ≥18 years,
  • ECOG Performance status (PS) 0-2,
  • Hematological status: neutrophils (ANC) ≥1.5x109/L; platelets ≥100x109/L; haemoglobin ≥9g/dL,
  • Adequate renal function: serum creatinine level <150µM,
  • Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alkaline phosphatase <5xULN,
  • Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour,
  • Baseline evaluations performed before randomization when the KRAS WT status is known: clinical and blood evaluations no more than 2 weeks (14 days) prior to randomization, tumor assessment (CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to randomization,
  • Female patients must commit to using reliable and appropriate methods of contraception during the trial and until at least six months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another contraceptive method during the trial and until at least 6 months after the end of the study treatment,
  • Registration in a national health care system (CMU included for France).

Who cannot join

  • History or evidence upon physical examination of CNS metastasis (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy), unless adequately treated,
  • Exclusive bone metastasis,
  • Uncontrolled hypercalcemia,
  • Pre-existing permanent neuropathy (NCI grade ≥2),
  • Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy,
  • Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
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  • Treatment with any investigational medicinal product within 28 days prior to study entry,
  • Other serious and uncontrolled non-malignant disease,
  • Gilbert's syndrome,
  • Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
  • Major surgery (open biopsy, surgical resection, wound revision or any other major surgery involving entry into body cavity) or significant traumatic injury within the last 28 days prior to randomization, and/or minor surgical procedure including placement of a vascular device within 2 days of first study treatment,
  • Pregnant or breastfeeding women,
  • Patients with known allergy/hypersensitivity to any component of study drugs,
  • History of arterial thrombo and/or embolic event (e.g. myocardial infarction, stroke,…) within 6 months prior to randomization,
  • Chronic inflammatory bowel disease
  • Total bowel obstruction,
  • History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to randomization,
  • Serious, non-healing wound, active ulcer or untreated bone fracture,
  • History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding,
  • Current or recent (within 10 days of randomization) use of aspirin (>325 mg/d), clopidogrel (>75 mg/d) or use of oral anticoagulants or thrombolytic agents.
  • Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine
  • Concomitant administration of prophylactic phenytoin.
  • Treatment with sorivudine or its chemically related analogues, such as brivudine.
  • Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Concomitant use with St John's Wort
  • Patients with interstitial pneumonitis or pulmonary fibrosis

Trial locations and contacts

56 sites in 3 countries.

56 sites in 3 countries

France44 sites

  • Centre Hospitalier Annecy Gennevois

    Annecy

  • Centre hospitalier Auxerre

    Auxerre

  • Centre François Baclesse

    Caen

  • Centre Hospitalier

    Cannes, 06400

  • Centre Hospitalier Chateauroux

    Châteauroux

  • Hospices Civils de Colmar

    Colmar

  • Hôpital Henri Mondor

    Créteil

  • Centre Hospitalier

    Dax, 40107

  • Centre d'oncologie et de radiothérapie du Parc

    Dijon

  • Centre Georges François Leclerc

    Dijon

  • CHD Vendée

    La Roche-sur-Yon

  • Hôpital Louis Pasteur

    Le Coudray

  • Hôpital Privé de l'Estuaire

    Le Havre

  • Clinique Victor Hugo

    Le Mans

  • Institut d'oncoloige Hartmann

    Levallois-Perret

  • Institut Hospitalier Franco-Britannique

    Levallois-Perret

  • Centre Bourgogne

    Lille

  • Centre Hospitalier de Bretagne Sud

    Lorient

  • Hôpital Privé Jean Mermoz

    Lyon

  • Hôpital Européen

    Marseille

  • Hôpital Nord

    Marseille

  • Centre Hospitalier Layné

    Mont-de-Marsan

  • Centre d'oncologie de Gentilly

    Nancy

  • Centre Sainte Catherine de Sienne

    Nantes

  • Hôpital Cochin

    Paris

  • Hôpital Pitié-Salpêtrière

    Paris

  • Hôpital Saint-Antoine

    Paris

  • Hôpital Saint-Joseph

    Paris

  • Hôpital Saint-Louis

    Paris

  • Hôpital Tenon

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • Hôpital Périgueux

    Périgueux

  • Clinique Armoricaine de Radiologie

    Saint-Brieuc

  • Clinique de l'Alliance

    Saint-Cyr-sur-Loire

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez

  • CH de Senlis

    Senlis

  • Centre Hospitalier de Sens

    Sens

  • Hôpital Broussais - CH Saint Malo

    St-Malo

  • Clinique Sainte-Anne

    Strasbourg

  • Hôpital Foch

    Suresnes

  • Hôpitaux du Léman

    Thonon-les-Bains, 74200

  • Hôpital Sainte Musse

    Toulon

  • Clinique Générale

    Valence

  • Institut de Cancérologie

    Villeneuve-d'Ascq, 59657

Other trials in France

Ireland10 sites

  • Bon Secours Hospital

    Cork

  • Cork University Hospital

    Cork

  • Adelaide & Meath Hospital Dublin ( AMNCH)

    Dublin

  • Beaumont Hospital

    Dublin

  • Mater Misericordiae University Hospital

    Dublin

  • Mater Private Hospital

    Dublin

  • St. James's Hospital

    Dublin

  • St. Vincent's University Hospital

    Dublin

  • University Hospital Galway

    Galway

  • University Hospital Waterford

    Waterford

Other trials in Ireland

Israel2 sites

  • Sheba Tel Hashomer

    Ramat Gan

  • Assaf Harofeh Medical Center

    Tsrifin

Other trials in Israel

About this study

Official title: Multi-Line Therapy Trial in Unresectable Wild-Type RAS Metastatic Colorectal Cancer. A GERCOR Randomized Open-label Phase III Study.

STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer.

Read the detailed description

This is a phase III study assessing 2 mutli-line therapeutic strategies in patients with unresectable wild-type RAS metastatic colorectal cancer. All the available treatments are being used in each strategy (oxaliplatine, irinotecan, fluoropyrimidines, bevacizumab, cetuximab or panitumumab) but in a different order:

STRATEGY A: FOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab vs.

STRATEGY B: OPTIMOX-bevacizumab, followed by irinotecan-based chemotherapy with bevacizumab, followed by anti-EGFR mab with or without irinotecan.

Being tested
FOLFIRI-cetuximab, mFOLFOX6-bevacizumab, OPTIMOX-bevacizumab, irinotecan-based chemo + bevacizumab, Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)
Keywords
wild-type RAS metastatic colorectal cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFIRI-cetuximabBiological

  • mFOLFOX6-bevacizumabBiological

  • OPTIMOX-bevacizumabBiological

  • irinotecan-based chemo + bevacizumabBiological

  • Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)Biological

  • XELOX + bevacizumabBiological

Study groups in NCT01910610
Study groupRoleWhat they receive
STRATEGY AExperimentalFOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab
Receives: Biological: FOLFIRI-cetuximab; Biological: mFOLFOX6-bevacizumab; Biological: XELOX + bevacizumab
STRATEGY BExperimentalOPTIMOX-bevacizumab, followed by irinotecan-based chemotherapy with bevacizumab, followed by anti-EGFR mab with or without irinotecan
Receives: Biological: OPTIMOX-bevacizumab; Biological: irinotecan-based chemo + bevacizumab; Biological: Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab); Biological: XELOX + bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Disease Control (DDC)

    DDC is defined as the sum of PFS of each active treatment course planned in the treatment strategy. DDC excludes 1) intervals between disease progression and re-initiation of treatment, and 2) PFS of inactive treatment if PD occurs at first evaluation after treatment re-initiation (either reintroduction in a stop-and-go strategy or subsequent course of treatment in a multi-line strategy).

    Measured: From baseline until end of strategy; up to 80 months after the beginning of the study

Secondary outcomes (7)

  1. Assessment of Quality of life (QoL)

    QoL will be considered to be improved if at least one time to QoL score deterioration (5 targeted dimensions) will be significantly longer without a significant shorter time to QoL score dimensions for other 4 targeted dimensions.

    Measured: From baseline until end of strategy; up to 80 months after the beginning of the study

  2. Overall Survival (OS)

    Time from randomization to the date of death from any cause

    Measured: Up to 80 months after the beginning of the study

  3. Time to Failure of Strategy (TFS)

    TFS is defined as beginning with the initiation of the strategy under investigation and ending with the first of the following events: 1) death, 2) disease progression on the last received planned sequence, 3) patient requires the addition of a new (unplanned) therapeutic agent, 4) patient experiences disease progression during a partial or complete break in therapy from initial treatment strategy and receives no further therapy within one month.

    Measured: Up to 80 months after the beginning of the study

  4. Progression-free survival (PFS) per sequence of therapy

    Time from randomization to the date of first documented disease progression or death from any cause, whichever occurs first.

    Measured: Up to 80 months after the beginning of the study

  5. Tumor Response Rate (RR)

    Tumor response will be assessed using RECIST version 1.1 per sequence of therapy

    Measured: From baseline until end of strategy; up to 80 months after the beginning of the study

  6. Curative salvage surgery rate

    The number of patient with R0 and R1 curative salvage surgery will be assessed globally (per arm) and per sequence of therapy

    Measured: From baseline until end of strategy; up to 80 months after the beginning of the study

  7. Safety profile of each treatment sequence

    The report will take into account all adverse events observed during and after drug administration, including any adverse events that may be related to the administration procedure itself.

    Measured: From study entry to 1 month after last study drug administration; up to 80 months after the beginning of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2013 (estimated)
  2. Study start30 Oct 2013
  3. Primary completion13 Jul 2023
  4. Study completionDec 2024 (estimated)

Resources

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
464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01910610
Sponsor's protocol ID
STRATEGIC-1 C12- 2
Other IDs
2013-001928-19
Acronym
STRATEGIC-1
Status last verified
Mar 2024
First submitted
23 Jul 2013
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Chibaudel B, Bonnetain F, Tournigand C, de Larauze MH, de Gramont A, Laurent-Puig P, Paget J, Hadengue A, Notelet D, Benetkiewicz M, Andre T, de Gramont A. STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer. BMC Cancer. 2015 Jul 4;15:496. doi: 10.1186/s12885-015-1503-7.

    PubMed 26141683

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FOLFIRI-cetuximab, mFOLFOX6-bevacizumab and OPTIMOX-bevacizumab in people with Colorectal Cancer Metastatic, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 56 sites in 3 countries.

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 26 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in France, Ireland, Israel. 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?

Duration of Disease Control (DDC) (time frame: From baseline until end of strategy; up to 80 months after the beginning of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01910610, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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