ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    STRATEGIC GERCOR
Previous Study | Return to List | Next Study

Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer (STRATEGIC-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01910610
Recruitment Status : Recruiting
First Posted : July 29, 2013
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Biological: FOLFIRI-cetuximab Biological: mFOLFOX6-bevacizumab Biological: OPTIMOX-bevacizumab Biological: irinotecan-based chemo + bevacizumab Biological: Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab) Biological: XELOX + bevacizumab Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Line Therapy Trial in Unresectable Wild-Type RAS Metastatic Colorectal Cancer. A GERCOR Randomized Open-label Phase III Study.
Study Start Date : July 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STRATEGY A
FOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab
Biological: FOLFIRI-cetuximab
Biological: mFOLFOX6-bevacizumab
Biological: XELOX + bevacizumab
Experimental: STRATEGY B
OPTIMOX-bevacizumab, followed by irinotecan-based chemotherapy with bevacizumab, followed by anti-EGFR mab with or without irinotecan
Biological: OPTIMOX-bevacizumab
Biological: irinotecan-based chemo + bevacizumab
Biological: Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)
Biological: XELOX + bevacizumab



Primary Outcome Measures :
  1. Duration of Disease Control [ Time Frame: From baseline until end of strategy, assessed up to 80 months after the beginning of the study ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: from baseline until end of strategy, assessed up to 80 months after the beginning of the study ]
    QoL will be considered to be improved if at least one time to QoL score deterioration (Five targeted dimensions) will be significantly longer without a significant shorter time to QoL score dimensions for other 4 targeted dimensions.

  2. Overall Survival [ Time Frame: time interval from randomization to the date of death from any cause. Assessed up to 80 months after the beginning of the study. ]
  3. Time to Failure of Strategy [ Time Frame: Assessed up to 80 months after the beginning of the study ]
    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.

  4. Progression-free survival (PFS) per sequence of therapy [ Time Frame: the time interval from randomization to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed up to 80 months after the beginning of the study ]
  5. Tumor Response Rate (RR) [ Time Frame: from baseline until end of strategy, assessed up to 80 months after the beginning of the study ]
  6. Curative salvage surgery rate [ Time Frame: from baseline until end of strategy, assessed up to 80 months after the beginning of the study ]
  7. Safety profile of each treatment sequence [ Time Frame: Assessed from study entry to 1 month after last study drug administration, assessed up to 80 months after the beginning of the study ]

    The study will take into account all adverse events observed during and after drug administration, with a particular interest for:

    Any AE Any serious AE Any serious AE related to study treatment Any NCI-CTC grade 3 or 4 AE Any AE causing discontinuation of study treatment Any AE causing a dose reduction of study medication Any AE leading to death




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent, and willing and able to comply with protocol requirements,
  2. Histologically proven adenocarcinoma of the colon and/or rectum,
  3. 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
  4. Metastatic disease confirmed,
  5. 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),
  6. 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],
  7. At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1,
  8. Age ≥18 years,
  9. ECOG Performance status (PS) 0-2,
  10. Hematological status: neutrophils (ANC) ≥1.5x109/L; platelets ≥100x109/L; haemoglobin ≥9g/dL,
  11. Adequate renal function: serum creatinine level <150µM,
  12. Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alkaline phosphatase <5xULN,
  13. Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour,
  14. 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,
  15. 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,
  16. Registration in a national health care system (CMU included for France).

Exclusion Criteria:

  1. 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,
  2. Exclusive bone metastasis,
  3. Uncontrolled hypercalcemia,
  4. Pre-existing permanent neuropathy (NCI grade ≥2),
  5. Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy,
  6. Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
  7. Treatment with any investigational medicinal product within 28 days prior to study entry,
  8. Other serious and uncontrolled non-malignant disease,
  9. Gilbert's syndrome,
  10. 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,
  11. 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,
  12. Pregnant or breastfeeding women,
  13. Patients with known allergy/hypersensitivity to any component of study drugs,
  14. History of arterial thrombo and/or embolic event (e.g. myocardial infarction, stroke,…) within 6 months prior to randomization,
  15. Chronic inflammatory bowel disease
  16. Total bowel obstruction,
  17. History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to randomization,
  18. Serious, non-healing wound, active ulcer or untreated bone fracture,
  19. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding,
  20. 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.
  21. Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine
  22. Concomitant administration of prophylactic phenytoin.
  23. Treatment with sorivudine or its chemically related analogues, such as brivudine.
  24. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
  25. Concomitant use with St John's Wort
  26. Patients with interstitial pneumonitis or pulmonary fibrosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910610


Contacts
Contact: Benoist Chibaudel, MD +33(0)1 47 59 19 23

  Show 56 Study Locations
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Hoffmann-La Roche
Investigators
Principal Investigator: Benoist Chibaudel, MD Institut Hospitalier Franco-Britannique

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT01910610     History of Changes
Other Study ID Numbers: STRATEGIC-1 C12- 2
2013-001928-19 ( EudraCT Number )
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Keywords provided by GERCOR - Multidisciplinary Oncology Cooperative Group:
wild-type RAS metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Irinotecan
Camptothecin
Cetuximab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action