FIrst Line Treatment of Metastatic Pancreatic Cancer: Seq... | NCT02827201

Status Module

Name	Class
UNICANCER	OTHER
GERCOR - Multidisciplinary Oncology Cooperative Group	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nab-paclitaxel + gemcitabine/FOLFIRI.3	Experimental	Alternance of : 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression	Drug: FOLFIRI.3 Drug: nab-paclitaxel+ gemcitabine
nab-paclitaxel + gemcitabine	Active Comparator	nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression	Drug: nab-paclitaxel+ gemcitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FOLFIRI.3	Drug	For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization	The primary endpoint was the rate of patients alive and progression-free 6 months after randomization. Progression was assessed by the investigator and defined radiologically according to RECIST v1.1 criteria and/or clinically as deterioration of general condition not related to treatment, palpable tumor masses on clinical examination (adenopathy, tumor hepatomegaly, peritoneal carcinosis), pleural effusion, ascites. Patients who progressed or died before 6 months were considered to have failed the primary endpoint at 6 months. The 6-month imaging was the imaging done at 6 months with a +/- 1 month window.	6 months after randomization

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS):	Overall survival was defined as the time from the date of randomization to the patient's death (all causes). For alive patients, the date of last news was taken into account	Up to 2 years after the treatment start
Best Response

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological or cytological confirmation of pancreatic adenocarcinoma
Distant metastatic disease
Scan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
At least one lesion measurable by RECIST v1.1 criteria
Life expectancy> 3 months
No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
Pain must be monitored before inclusion
18 years < age < 75
Performance status: WHO < 2
ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
Women of childbearing age must have a negative pregnancy test (β HCG) before starting treatment
Women of childbearing age as well as men (who have sexual intercourse with women of childbearing age) must agree to use effective contraception without interruption for the duration of treatment and 6 months after the administration of the last treatment dose
Patient affiliated to the social security scheme
Patient information and signature of informed consent

Exclusion Criteria:

- Other types of pancreatic tumours, especially endocrine or acinar cell tumours
Ampulloma
Presence of meningeal or cerebral metastases, bone metastases
Gilbert's syndrome
Presence of neuropathy> grade 1 according to NCIC-CTC 4.0
Contraindications specific to the studied treatments
History of chronic diarrhoea or inflammatory disease of the colon or rectum, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
Other concomitant cancer or history of cancer during the 5 years, with the exception of a carcinoma in situ of the cervix or basal cell or squamous cell carcinoma, considered cured
Significant history of heart or respiratory disease, including any history of interstitial pneumonia
Patient already included in another clinical trial with an experimental molecule
Women who are breast-feeding
Persons deprived of liberty or under guardianship
Unable to submit to medical monitoring during the trial due to geographical, social or psychological reasons

Name	Affiliation	Role
Julien TAIEB, Pr	HEGP - PARIS - FRANCE	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Privée Claude Bernard		Albi			France
CH

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32623182	Result	Rinaldi Y, Pointet AL, Khemissa Akouz F, Le Malicot K, Wahiba B, Louafi S, Gratet A, Miglianico L, Laharie H, Bouhier Leporrier K, Thirot Bidault A, Texereau P, Coriat R, Terrebonne E, Gouttebel MC, Malka D, Bachet JB, Lepage C, Taieb J; PRODIGE 37 Investigators/Collaborators. Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancerologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX). Eur J Cancer. 2020 Sep;136:25-34. doi: 10.1016/j.ejca.2020.05.018. Epub 2020 Jul 2.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nab-paclitaxel + Gemcitabine/FOLFIRI.3	Alternance of : 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over) nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 8, 2014	Jul 5, 2024

Arm/Group Information

ID	Title	Description
BG000	Nab-paclitaxel + Gemcitabine/FOLFIRI.3	Alternance of : 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over) nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
BG001	Nab-paclitaxel + Gemcitabine	nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	BG00065.20(57.66 to 69.70) BG00165.99(59.42 to 69.54) BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00028 BG00134 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

France

Title	Measurements
	BG00064 BG00163 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization

The primary endpoint was the rate of patients alive and progression-free 6 months after randomization.

Progression was assessed by the investigator and defined radiologically according to RECIST v1.1 criteria and/or clinically as deterioration of general condition not related to treatment, palpable tumor masses on clinical examination (adenopathy, tumor hepatomegaly, peritoneal carcinosis), pleural effusion, ascites.

Patients who progressed or died before 6 months were considered to have failed the primary endpoint at 6 months.

The 6-month imaging was the imaging done at 6 months with a +/- 1 month window.

The primary endpoint was analysed on the mITT population meaning all the randomized patients with at least one dose of study drug taken

Posted

Count of Participants

Participants

6 months after randomization

ID	Title	Description
OG000	Nab-paclitaxel + Gemcitabine/FOLFIRI.3	Alternance of : 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over) nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
OG001	Nab-paclitaxel + Gemcitabine	nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

Units	Counts
Participants	OG00062 OG00160

Title

Denominators

Categories

Title	Measurements
	OG00028 OG00114

Secondary

Overall Survival (OS):

Overall survival was defined as the time from the date of randomization to the patient's death (all causes). For alive patients, the date of last news was taken into account

Endpoint was analyzed on the ITT population

Posted

Median

95% Confidence Interval

months

Up to 2 years after the treatment start

ID	Title	Description
OG000	Nab-paclitaxel + Gemcitabine/FOLFIRI.3	Alternance of : 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over) nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
OG001	Nab-paclitaxel + Gemcitabine	nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

Secondary

Best Response

Best response is defined as the best response for each patient regarding imagerie taken during the treatment. Response was evalauted according to RECIST v1.1 over the entire treatment period according the investigator

Endpoint was analysed on mITT population meaning all randomized patients having at least one dose of treatment

Posted

Count of Participants

Participants

Up to the end of treatment on the average of 12 months

ID	Title	Description
OG000	Nab-paclitaxel + Gemcitabine/FOLFIRI.3	Alternance of : 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over) nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
OG001	Nab-paclitaxel + Gemcitabine

Secondary

Progression-free Survival (PFS)

It was defined as the time between t randomization and the date of the first radiological progression (RECIST 1.1 criteria) and/or clinical progression according to the investigator or death (whatever the cause is); Patients alive without progression were censored at date of last news

Posted

Median

95% Confidence Interval

months

up to 12 months after randomization

ID	Title	Description
OG000	Nab-paclitaxel + Gemcitabine/FOLFIRI.3	Alternance of : 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over) nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
OG001	Nab-paclitaxel + Gemcitabine	nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nab-paclitaxel + Gemcitabine/FOLFIRI.3	Alternance of : 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over) nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.	53	64	30	64	63	64
EG001	Nab-paclitaxel + Gemcitabine	nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.	54	63	19	58	58	58

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac arrest	Cardiac disorders	NCI-CTC version 4.0	Systematic Assessment	EG0000 affected64 at risk EG0012 affected58 at risk
Transient Ischemic Attack	Nervous system disorders	NCI-CTC version 4.0	Systematic Assessment	EG0001 affected64 at risk EG0010 affected58 at risk
Abdominal pain	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG0005 affected64 at risk EG0011 affected58 at risk
Hypocellular bone marrow	Blood and lymphatic system disorders	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected64 at risk EG0011 affected58 at risk
Venous thromboembolic event	Vascular disorders	NCI-CTC version 4.0	Systematic Assessment	EG0001 affected64 at risk EG0012 affected58 at risk
Thromboembolic event	Vascular disorders	NCI-CTC version 4.0	Systematic Assessment	EG0001 affected64 at risk EG0011 affected58 at risk
Catheter infection	Infections and infestations	NCI-CTC version 4.0	Systematic Assessment	EG0004 affected64 at risk EG0012 affected58 at risk
Biliary tract infection	Hepatobiliary disorders	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected64 at risk EG0012 affected58 at risk
Septicemia	Infections and infestations	NCI-CTC version 4.0	Systematic Assessment	EG0005 affected64 at risk EG0016 affected58 at risk
Hypokaliemia	Metabolism and nutrition disorders	NCI-CTC version 4.0	Systematic Assessment	EG0003 affected64 at risk EG0010 affected58 at risk
Multivisceral failure	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG0001 affected64 at risk EG0010 affected58 at risk
Fatigue	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG0005 affected64 at risk EG0015 affected58 at risk
Thrills	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG0000 affected64 at risk EG0012 affected58 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	NCI-CTC version 4.0	Systematic Assessment	EG0005 affected64 at risk EG0011 affected58 at risk
Alopecia	Skin and subcutaneous tissue disorders	NCI-CTC version 4.0	Systematic Assessment	EG00031 affected64 at risk EG00132 affected58 at risk
Palmo-palmar syndrome	Skin and subcutaneous tissue disorders	NCI-CTC version 4.0	Systematic Assessment	EG0008 affected64 at risk EG0013 affected58 at risk
Allergic reaction	Immune system disorders	NCI-CTC version 4.0	Systematic Assessment	EG0006 affected64 at risk EG0014 affected58 at risk
Cephalgia	Nervous system disorders	NCI-CTC version 4.0	Systematic Assessment	EG0004 affected64 at risk EG0017 affected58 at risk
Paresthesia	Nervous system disorders	NCI-CTC version 4.0	Systematic Assessment	EG00022 affected64 at risk EG00123 affected58 at risk
Dysgueusia	Nervous system disorders	NCI-CTC version 4.0	Systematic Assessment	EG0005 affected64 at risk EG0015 affected58 at risk
Constipation	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG00015 affected64 at risk EG00118 affected58 at risk
Diarrhea	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG00045 affected64 at risk EG00135 affected58 at risk
Mucitis	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG00014 affected64 at risk EG00112 affected58 at risk
Nausea	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG00042 affected64 at risk EG00130 affected58 at risk
Vomiting	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG00030 affected64 at risk EG00121 affected58 at risk
Abdominal pain	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG00025 affected64 at risk EG00116 affected58 at risk
Anemia	Blood and lymphatic system disorders	NCI-CTC version 4.0	Systematic Assessment	EG00058 affected64 at risk EG00155 affected58 at risk
Sensitive neuropathie peripheral	Nervous system disorders	NCI-CTC version 4.0	Systematic Assessment	EG00015 affected64 at risk EG00116 affected58 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG0006 affected64 at risk EG0013 affected58 at risk
Venous thromboembolic event	Vascular disorders	NCI-CTC version 4.0	Systematic Assessment	EG00010 affected64 at risk EG0016 affected58 at risk
Anorexia	Metabolism and nutrition disorders	NCI-CTC version 4.0	Systematic Assessment	EG00038 affected64 at risk EG00126 affected58 at risk
Fatigue	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG00057 affected64 at risk EG00149 affected58 at risk
Fever	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG00024 affected64 at risk EG00118 affected58 at risk
Inferior members oedema	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG00016 affected64 at risk EG00114 affected58 at risk

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases