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History of Changes for Study: NCT01910610
Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer (STRATEGIC-1)
Latest version (submitted June 11, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 25, 2013 None (earliest Version on record)
2 April 29, 2014 Recruitment Status, Study Status, Contacts/Locations, Conditions, Eligibility, Study Description and Study Identification
3 October 29, 2014 Contacts/Locations and Study Status
4 December 10, 2014 Contacts/Locations, Eligibility and Study Status
5 January 16, 2015 Contacts/Locations and Study Status
6 December 10, 2015 Study Status
7 August 22, 2016 Study Status
8 September 12, 2016 Contacts/Locations and Study Status
9 December 22, 2017 Contacts/Locations and Study Status
10 February 26, 2019 Study Status
11 June 11, 2021 Outcome Measures and Study Status
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Study NCT01910610
Submitted Date:  July 25, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: STRATEGIC-1 C12- 2
Brief Title: Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer (STRATEGIC-1)
Official Title: Multi-Line Therapy Trial in Unresectable Wild-Type KRAS Metastatic Colorectal Cancer. A GERCOR Randomized Open-label Phase III Study.
Secondary IDs: 2013-001928-19 [EudraCT Number]
Open or close this module Study Status
Record Verification: July 2013
Overall Status: Not yet recruiting
Study Start: July 2013
Primary Completion: December 2019 [Anticipated]
Study Completion: December 2019 [Anticipated]
First Submitted: July 23, 2013
First Submitted that
Met QC Criteria:
July 25, 2013
First Posted: July 29, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 25, 2013
Last Update Posted: July 29, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Responsible Party: Sponsor
Collaborators: Hoffmann-La Roche
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer.
Detailed Description:

This is a phase III study assessing 2 mutli-line therapeutic strategies in patients with unresectable wild-type KRAS 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.

Open or close this module Conditions
Conditions: Wild-type KRAS Metastatic Colorectal Cancer
Keywords: wild-type KRAS metastatic colorectal cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 474 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: STRATEGY A
FOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab
Biological: FOLFIRI-cetuximabBiological: mFOLFOX6-bevacizumabBiological: 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-bevacizumabBiological: irinotecan-based chemo + bevacizumabBiological: Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)Biological: XELOX + bevacizumab
Open or close this module Outcome Measures
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

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 KRAS tumor (local assessment, performed either on primary tumor or metastasis),
  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
Open or close this module Contacts/Locations
Central Contact Person: Benoist Chibaudel, MD
Telephone: +33 (0)1 49 28 23 45
Study Officials: Benoist Chibaudel, MD
Principal Investigator
Hôpital Saint Antoine
Locations: France
Centre François Baclesse
Caen, France
Contact:Contact: Aurélie PARZY, MD
Contact:Principal Investigator: Aurélie PARZY, MD
Hôpital Beaujon
Clichy, France
Contact:Contact: Pascal HAMMEL, MD, PhD
Contact:Principal Investigator: Pascal HAMMEL, MD, PhD
Hospices Civils de Colmar
Colmar, France
Contact:Contact: Gilles BREYSACHER, MD
Contact:Principal Investigator: Gilles BREYSACHER, MD
Hôpital Henri Mondor
Créteil, France
Contact:Contact: Christophe TOURNIGAND, MD
Contact:Principal Investigator: Christophe TOURNIGAND, MD
Centre Georges François Leclerc
Dijon, France
Contact:Contact: François GHIRINGHELLI, MD
Contact:Principal Investigator: François GHIRINGHELLI, MD
CHD Vendée
La Roche sur Yon, France
Contact:Contact: Roger FAROUX, MD
Contact:Principal Investigator: Roger FAROUX, MD
Hôpital Saint-Louis
Le Coudray, France
Contact:Contact: Gabriela TOSSEN, MD
Contact:Principal Investigator: Gabriela TOSSEN, MD
Clinique Victor Hugo
Le Mans, France
Contact:Contact: Olivier DUPUIS, MD
Contact:Principal Investigator: Olivier DUPUIS, MD
Centre Hospitalier de Bretagne Sud
Lorient, France
Contact:Contact: Joëlle EGRETEAU, MD
Contact:Principal Investigator: Joëlle EGRETEAU, MD
Hôpital Privé Jean Mermoz
Lyon, France
Contact:Contact: Jérôme DESRAME, MD
Contact:Principal Investigator: Jérôme DESRAME, MD
Hôpital Ambroise Paré
Marseille, France
Contact:Contact: Yves RINALDI, MD
Contact:Principal Investigator: Yves RINALDI, MD
Hôpital Nord
Marseille, France
Contact:Contact: Mohamed GASMI, MD
Contact:Principal Investigator: Mohamed GASMI, MD
Centre Hospitalier Layné
Mont de Marsan, France
Contact:Contact: Jérôme DAUBA, MD
Contact:Principal Investigator: Jérôme DAUBA, MD
Centre d'oncologie de Gentilly
Nancy, France
Contact:Contact: Fabien BROCARD, MD
Contact:Principal Investigator: Fabien BROCARD, MD
Centre Sainte Catherine de Sienne
Nantes, France
Contact:Contact: Jean-François RAMEE, MD
Contact:Principal Investigator: Jean-François RAMEE, MD
Hôpital Pitié-Salpêtrière
Paris, France
Contact:Contact: Jean-Baptiste BACHET, MD
Contact:Principal Investigator: Jean-Baptiste BACHET, MD
Hôpital Saint-Antoine
Paris, France
Contact:Contact: Benoist CHIBAUDEL, MD
Contact:Principal Investigator: Benoist CHIBAUDEL, MD
Hôpital Saint-Joseph
Paris, France
Contact:Contact: Gaël DEPLANQUE, MD
Contact:Principal Investigator: Gaël DEPLANQUE, MD
Hôpital Saint-Louis
Paris, France
Contact:Contact: Jean-Marc GORNET, MD
Contact:Principal Investigator: Jean-Marc GORNET, MD
Hôpital Tenon
Paris, France
Contact:Contact: Ahmed KHALIL, MD, PhD
Contact:Principal Investigator: Ahmed KHALIL, MD, PhD
Institut Mutualiste Montsouris
Paris, France
Contact:Contact: Christophe LOUVET, MD
Contact:Principal Investigator: Christophe LOUVET, MD
Clinique Armoricaine de Radiologie
Saint-Brieuc, France
Contact:Contact: Pierre-Luc ETIENNE, MD
Contact:Principal Investigator: Pierre-Luc ETIENNE, MD
CH de Senlis
Senlis, France
Contact:Contact: Dr Elisabeth CAROLA, MD
Contact:Principal Investigator: Elisabeth CAROLA, MD
Clinique Sainte-Anne
Strasbourg, France
Contact:Contact: Louis Marie DOURTHE, MD
Contact:Principal Investigator: Louis-Marie DOURTHE, MD
Clinique Générale
Valence, France
Contact:Contact: Cyril BONAVENTURE, MD
Contact:Principal Investigator: Cyril BONAVENTURE, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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