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Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer (ARION)

Primary Purpose

Esophagus Cancer, Unresectable Malignant Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Durvalumab
IMRT 50 Gy + FOLFOX4 simplifIed (oxaliplatin, leucovorin, 5-FU)
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer focused on measuring oesophagus, localised unresectable, adenocarcinoma or squamous cell carcinoma, durvalumab, FOLFOX 4 simplified, Definitive modulated-intensity radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically proven squamous cell carcinoma or adenocarcinoma of the oesophagus,
  2. Unresectable disease due to anatomical consideration or medical condition (patient unfit for surgical procedure),
  3. Presence of at least one measurable lesion >10 mm with spiral CT scan,
  4. No prior therapy for pathology investigated including chemotherapy or radiotherapy prior to the study, except anterior out of field radiotherapy, received for treatment of another primary tumor considered in remission, in the past 5 years,
  5. Age ≥18 years old,
  6. WHO performance status <2 (i.e., 0 or 1),
  7. Body weight >35 kg,
  8. Life expectancy of at least 12 weeks ,
  9. Adequate haematology laboratory data within the 7 days before randomization

    1. Absolute neutrophils >1.5 x 109/L
    2. Platelets >100 x 109/L
    3. Haemoglobin ≥9 g/dL,
  10. Adequate Biochemistry laboratory data within the 7 days before randomization

    1. Total bilirubin ≤1.5 x upper limit of normal (ULN)
    2. Transaminases ≤2.5 x ULN
    3. Alkaline phosphatases ≤5 x ULN,
    4. Measured creatinine clearance (CL) >40 mL/min by the Cockcroft-Gault formula,
    5. Glycaemia ≤1.5 x ULN
    6. Cholesterolaemia ≤7.30 mmol/L,
    7. Albumin >28 g/L
  11. Adequate haemostasis laboratory data within 7 days prior to randomization: prothrombin time (PT) within the normal range,
  12. Adequate values for calcium, potassium and magnesium levels measured within 7 days prior to randomization,
  13. Women should be post-menopaused or willing to accept the use an effective contraceptive regimen during the treatment period and for at least 6 months after the end of the study. All non-menopausal women should have a negative pregnancy test within 72 h prior to randomization. Men should accept to use an effective contraception during treatment period and at least 6 months after the end of the study especially after the last dose of oxaliplatin treatment.
  14. Patients must have provided consent for the study by signing and dating a written informed consent form prior to any study specific procedures, sampling, or analyses,
  15. Patient affiliated to a social security regimen.
  16. Uracilemia < 16ng/ml
  17. Forced expiratory volume (FEV) >1 liter or > 50% of the theoretical value

Exclusion Criteria:

  1. Previous treatment with another PD-1, PD-L1 including durvalumab or CTLA-4 inhibitor
  2. Metastatic disease,
  3. Patients should not receive live vaccine 30 days prior to study drug
  4. Female patients who are pregnant or breastfeeding
  5. Uncontrolled intercurrent illness including, but not limited to diabetes, hypertension, pulmonary failure, chronic renal or hepatic diseases, active peptic ulcer disease or gastritis, active bleeding, diatheses... (non-exhaustive list),
  6. Clinically significant cardiac disease or impaired cardiac function, such as:

    1. Congestive heart failure requiring treatment (New York Heart Association [NYHA] grade ≥2), left ventricular ejection fraction (LVEF) <50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled arterial hypertension defined by blood pressure >140/100 mmHg at rest (average of 3 consecutive readings),
    2. History or current evidence of clinically significant cardiac arrhythmias, atrial fibrillation and/or conduction abnormality, e.g. congenital long QT syndrome, high- grade/complete AV-blockage,
    3. Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting), <3 months prior to screening,
    4. MeanQT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction.
  7. Current or prior use of immunosuppressive medication within 28 days before the first administration of durvalumab (exception: systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or equivalent are allowed as well as steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) - Topical, inhaled, nasal, and ophthalmic steroids are allowed,
  8. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:

    1. Patients with vitiligo or alopecia
    2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stabilised with hormone replacement therapy
    3. Any chronic skin condition that does not require systemic therapy
    4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician
    5. Patients with coeliac disease controlled by diet alone
  9. Known primary immunodeficiency or active HIV,
  10. Patient with a dihydropyrimidine dehydrogenase (DPD) deficiency (Uracilemia ≥ 16 ng/ml, the test should be done for all patients before 5-FU administration)* ,
  11. Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months indicated by positive HBS antibody test for hepatitis B or hepatitis C virus ribonucleic acid (HCV antibody),
  12. History of organ transplantation requiring the use of immunosuppressive medication, including allogenic stem cell transplant
  13. History of active tuberculosis or latent disease capable of reactivation,
  14. Current pneumonitis or interstitial lung disease,
  15. Other invasive malignancy within 2 years prior to entry into the study, except for those treated with surgical therapy only,
  16. History of severe allergic reactions or hypersensitivity to any unknown allergens or any components of the study drug (refer to IB of durvalumab section 5.5.1.11).
  17. Any prior corticosteroid-refractory immune-related adverse event (irAE),
  18. Oeso-tracheal or oeso-bronchial fistulae,
  19. Major surgery within 28 days prior to the first dose of study treatment
  20. Toxicities of grade ≥1 from any previous therapy,
  21. Peripheral sensory neuropathy with functional impairment
  22. Severe infection requiring parenteral antibiotic treatment
  23. Patients treated with sorivudine or analogues as brivudine
  24. Patients treated with phenytoin for prophylaxis
  25. Participation in another therapeutic trial within the 30 days prior to study inclusion,
  26. Patients deprived of liberty or under guardianship,
  27. Patients unable to adhere to the protocol for geographical, social, or psychological reasons.

Sites / Locations

  • Centre Oscar Lambret, CLCC UNICANCER
  • Hôpital Saint Louis, APHP
  • Hôpital Haut-LévêqueRecruiting
  • Centre Hospitalier UniversitaireRecruiting
  • Centre Paul Strauss, CLCC UNICANCER
  • Iuct, Clcc UnicancerRecruiting
  • CHU Rangueil LarreyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Concomitant administration of durvalumab (dose: 1500 mg): Every 4 weeks during concurrent FOLFOX and after FOLFOX completion (total of 12 months of treatment) Definitive modulated-intensity radiotherapy will be delivered according to boost integrated technique 5 days a week for 5 weeks at a dose of: 50 Gy delivered in 25 fractions to the macroscopic disease (endoscopic, TDM and fused FDG PET) 45 Gy to the adjacent peri tumoral mucosis and prophylactic lymph node FOLFOX 4 simplified protocol, 1 infusion every 2 weeks during 3 months starting with radiotherapy (+/- 1 day): IV oxaliplatin 85 mg/m² in 2 h on D1 IV Leucovorin 200 mg/m² in 2 h on D1, followed by IV 5-FU 400 mg/m² in 10 minutes on D1 followed by IV continuous infusion 5-FU 2400 mg/m² in 46 h

Definitive modulated-intensity radiotherapy will be delivered according to boost integrated technique 5 days a week for 5 weeks at a dose of: 50 Gy delivered in 25 fractions to the macroscopic disease (endoscopic, TDM and fused FDG PET) 45 Gy to the adjacent peri tumoral mucosis and prophylactic lymph node FOLFOX 4 simplified protocol, 1 infusion every 2 weeks during 3 months starting with radiotherapy (+/- 1 day): IV oxaliplatin 85 mg/m² in 2 h on D1 IV Leucovorin 200 mg/m² in 2 h on D1, followed by IV 5-FU 400 mg/m² in 10 minutes on D1 followed by IV continuous infusion 5-FU 2400 mg/m² in 46 h

Outcomes

Primary Outcome Measures

cPFS (centrally reviewed cPFS)
defined by a blinded independent centralized revue of progression free survival. cPFS is defined as the time from randomization until progression or death; patients alive and without documented progression at last follow-up news have PFS censored at this date or at initiation of new anticancer treatment (if applicable). Progression will be defined with central external reviewing of TDM per RECIST v1.1

Secondary Outcome Measures

Overall survival (OS)
defined as the time between randomization and death due to any cause.
Adverse Events
will be assessed on occurrence of Adverse Events (AEs) based on NCI CTCAE v5.0
Quality of Life OES18, used for patients with oesophageal cancer always complemented by the QLQ-C30 measuring 5 functional scales (physical, everyday activity, cognitive, emotional and social) and 3 symptoms scales (fatigue, pain, nausea and vomiting)
scores EORTC QLQ C30 - OES18

Full Information

First Posted
December 11, 2018
Last Updated
August 30, 2023
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT03777813
Brief Title
Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer
Acronym
ARION
Official Title
Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer: a Comparative Randomized Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess the efficacy of durvalumab in combination with radiochemotherapy (FOLFOX and IMRT) and then as maintenance therapy for treating patients with localised unresectable oesophageal cancer. This is a randomized, French national, multicentre, comparative phase II trial
Detailed Description
ARION study will randomize 120 patients, in 12 centers in France, according to a ratio 1:1 in the following arm of treatment: - Standard and experimental arm: Definitive modulated-intensity radiotherapy will be delivered according to boost integrated technique 5 days a week for 5 weeks at a dose of: 50 Gy delivered in 25 fractions to the macroscopic disease (endoscopic, TDM and fused FDG PET) 45 Gy to the adjacent peri tumoral mucosis and prophylactic lymph node FOLFOX 4 simplified protocol, 1 infusion every 2 weeks (q2w) during 3 months starting with radiotherapy (+/- 1 day): IV oxaliplatin 85 mg/m² in 2 h on day 1 (D1) IV Leucovorin 200 mg/m² in 2 h on D1, followed by IV 5-FU 400 mg/m² in 10 minutes on D1 followed by IV continuous infusion 5-FU 2400 mg/m² in 46 h Experimental arm: Concomitant administration of durvalumab: Every 4 weeks during concurrent FOLFOX (dose: 1500 mg) and after FOLFOX completion (total of 12 months of treatment).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Unresectable Malignant Neoplasm
Keywords
oesophagus, localised unresectable, adenocarcinoma or squamous cell carcinoma, durvalumab, FOLFOX 4 simplified, Definitive modulated-intensity radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Concomitant administration of durvalumab (dose: 1500 mg): Every 4 weeks during concurrent FOLFOX and after FOLFOX completion (total of 12 months of treatment) Definitive modulated-intensity radiotherapy will be delivered according to boost integrated technique 5 days a week for 5 weeks at a dose of: 50 Gy delivered in 25 fractions to the macroscopic disease (endoscopic, TDM and fused FDG PET) 45 Gy to the adjacent peri tumoral mucosis and prophylactic lymph node FOLFOX 4 simplified protocol, 1 infusion every 2 weeks during 3 months starting with radiotherapy (+/- 1 day): IV oxaliplatin 85 mg/m² in 2 h on D1 IV Leucovorin 200 mg/m² in 2 h on D1, followed by IV 5-FU 400 mg/m² in 10 minutes on D1 followed by IV continuous infusion 5-FU 2400 mg/m² in 46 h
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Definitive modulated-intensity radiotherapy will be delivered according to boost integrated technique 5 days a week for 5 weeks at a dose of: 50 Gy delivered in 25 fractions to the macroscopic disease (endoscopic, TDM and fused FDG PET) 45 Gy to the adjacent peri tumoral mucosis and prophylactic lymph node FOLFOX 4 simplified protocol, 1 infusion every 2 weeks during 3 months starting with radiotherapy (+/- 1 day): IV oxaliplatin 85 mg/m² in 2 h on D1 IV Leucovorin 200 mg/m² in 2 h on D1, followed by IV 5-FU 400 mg/m² in 10 minutes on D1 followed by IV continuous infusion 5-FU 2400 mg/m² in 46 h
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
IMRT 50 Gy + FOLFOX4 simplifIed (oxaliplatin, leucovorin, 5-FU)
Intervention Description
Radiochemotherapy in standard arm and in experimental arm: 10 weeks (RT 50 Gy and FOLFOX q2w) Immunotherapy in experimental arm only: Patients will received concomitantly a maximum of 12 infusions
Intervention Type
Combination Product
Intervention Name(s)
IMRT 50 Gy + FOLFOX4 simplifIed (oxaliplatin, leucovorin, 5-FU)
Intervention Description
Radiochemotherapy in standard arm and in experimental arm: 10 weeks (RT 50 Gy and FOLFOX q2w)
Primary Outcome Measure Information:
Title
cPFS (centrally reviewed cPFS)
Description
defined by a blinded independent centralized revue of progression free survival. cPFS is defined as the time from randomization until progression or death; patients alive and without documented progression at last follow-up news have PFS censored at this date or at initiation of new anticancer treatment (if applicable). Progression will be defined with central external reviewing of TDM per RECIST v1.1
Time Frame
12-months cPFS
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
defined as the time between randomization and death due to any cause.
Time Frame
For each treatment arms, survival rates (PFS and OS) will be estimated at 12, 18 and 24 months
Title
Adverse Events
Description
will be assessed on occurrence of Adverse Events (AEs) based on NCI CTCAE v5.0
Time Frame
2 years after randomization
Title
Quality of Life OES18, used for patients with oesophageal cancer always complemented by the QLQ-C30 measuring 5 functional scales (physical, everyday activity, cognitive, emotional and social) and 3 symptoms scales (fatigue, pain, nausea and vomiting)
Description
scores EORTC QLQ C30 - OES18
Time Frame
2 years after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven squamous cell carcinoma or adenocarcinoma of the oesophagus, Unresectable disease due to anatomical consideration or medical condition (patient unfit for surgical procedure), Presence of at least one measurable lesion >10 mm with spiral CT scan, No prior therapy for pathology investigated including chemotherapy or radiotherapy prior to the study, except anterior out of field radiotherapy, received for treatment of another primary tumor considered in remission, in the past 5 years, Age ≥18 years old, WHO performance status <2 (i.e., 0 or 1), Body weight >35 kg, Life expectancy of at least 12 weeks , Adequate haematology laboratory data within the 7 days before randomization Absolute neutrophils >1.5 x 109/L Platelets >100 x 109/L Haemoglobin ≥9 g/dL, Adequate Biochemistry laboratory data within the 7 days before randomization Total bilirubin ≤1.5 x upper limit of normal (ULN) Transaminases ≤2.5 x ULN Alkaline phosphatases ≤5 x ULN, Measured creatinine clearance (CL) >40 mL/min by the Cockcroft-Gault formula, Glycaemia ≤1.5 x ULN Cholesterolaemia ≤7.30 mmol/L, Albumin >28 g/L Adequate haemostasis laboratory data within 7 days prior to randomization: prothrombin time (PT) within the normal range, Adequate values for calcium, potassium and magnesium levels measured within 7 days prior to randomization, Women should be post-menopaused or willing to accept the use an effective contraceptive regimen during the treatment period and for at least 6 months after the end of the study. All non-menopausal women should have a negative pregnancy test within 72 h prior to randomization. Men should accept to use an effective contraception during treatment period and at least 6 months after the end of the study especially after the last dose of oxaliplatin treatment. Patients must have provided consent for the study by signing and dating a written informed consent form prior to any study specific procedures, sampling, or analyses, Patient affiliated to a social security regimen. Uracilemia < 16ng/ml Forced expiratory volume (FEV) >1 liter or > 50% of the theoretical value Exclusion Criteria: Previous treatment with another PD-1, PD-L1 including durvalumab or CTLA-4 inhibitor Metastatic disease, Patients should not receive live vaccine 30 days prior to study drug Female patients who are pregnant or breastfeeding Uncontrolled intercurrent illness including, but not limited to diabetes, hypertension, pulmonary failure, chronic renal or hepatic diseases, active peptic ulcer disease or gastritis, active bleeding, diatheses... (non-exhaustive list), Clinically significant cardiac disease or impaired cardiac function, such as: Congestive heart failure requiring treatment (New York Heart Association [NYHA] grade ≥2), left ventricular ejection fraction (LVEF) <50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled arterial hypertension defined by blood pressure >140/100 mmHg at rest (average of 3 consecutive readings), History or current evidence of clinically significant cardiac arrhythmias, atrial fibrillation and/or conduction abnormality, e.g. congenital long QT syndrome, high- grade/complete AV-blockage, Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting), <3 months prior to screening, MeanQT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction. Current or prior use of immunosuppressive medication within 28 days before the first administration of durvalumab (exception: systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or equivalent are allowed as well as steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) - Topical, inhaled, nasal, and ophthalmic steroids are allowed, Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: Patients with vitiligo or alopecia Patients with hypothyroidism (e.g., following Hashimoto syndrome) stabilised with hormone replacement therapy Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the study physician Patients with coeliac disease controlled by diet alone Known primary immunodeficiency or active HIV, Patient with a dihydropyrimidine dehydrogenase (DPD) deficiency (Uracilemia ≥ 16 ng/ml, the test should be done for all patients before 5-FU administration)* , Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months indicated by positive HBS antibody test for hepatitis B or hepatitis C virus ribonucleic acid (HCV antibody), History of organ transplantation requiring the use of immunosuppressive medication, including allogenic stem cell transplant History of active tuberculosis or latent disease capable of reactivation, Current pneumonitis or interstitial lung disease, Other invasive malignancy within 2 years prior to entry into the study, except for those treated with surgical therapy only, History of severe allergic reactions or hypersensitivity to any unknown allergens or any components of the study drug (refer to IB of durvalumab section 5.5.1.11). Any prior corticosteroid-refractory immune-related adverse event (irAE), Oeso-tracheal or oeso-bronchial fistulae, Major surgery within 28 days prior to the first dose of study treatment Toxicities of grade ≥1 from any previous therapy, Peripheral sensory neuropathy with functional impairment Severe infection requiring parenteral antibiotic treatment Patients treated with sorivudine or analogues as brivudine Patients treated with phenytoin for prophylaxis Participation in another therapeutic trial within the 30 days prior to study inclusion, Patients deprived of liberty or under guardianship, Patients unable to adhere to the protocol for geographical, social, or psychological reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Pezzella
Phone
+33 (0)1 44 23 04 77
Email
v-pezzella@unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Monard
Email
l-monard@unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anouchka Modesto, Doctor
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurent Quero, Doctor
Organizational Affiliation
Hôpital Saint Louis / Université Paris Diderot
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret, CLCC UNICANCER
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farid EL HAJBI
Email
f-elhajbi@o-lambret.fr
Facility Name
Hôpital Saint Louis, APHP
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Quero
Email
laurent.quero@aphp.fr
Facility Name
Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique VENDRELY-BUTTIAUX
Email
veronique.vendrely@chu-bordeaux.fr
Facility Name
Centre Hospitalier Universitaire
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David TOUGERON
Email
david.tougeron@chu-poitiers.fr
Facility Name
Centre Paul Strauss, CLCC UNICANCER
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meher BEN ABDELGHANI
Email
mbenabdelghani@strasbourg.unicancer.fr
Facility Name
Iuct, Clcc Unicancer
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anouchka Modesto
Phone
+33 (0) 5 31 15 54 28
Email
Modesto.Anouchka@iuct-oncopole.fr
Facility Name
CHU Rangueil Larrey
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosine Guimbaud
Email
guimbaud.r@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
IPD Sharing Time Frame
The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
IPD Sharing Access Criteria
Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.

Learn more about this trial

Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer

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