Trial Outcomes & Findings for Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer (NCT NCT00766142)

Last Updated: 2025-08-29

Results Overview

Progression-free survival time is defined as the time from the date of surgery to the date of progression (as per RECIST v1.1) or death of any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Since surgery, up to 5 years

Results posted on

2025-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy + Cetuximab * Cetuximab 500 mg/m² IV * Oxaliplatine 85 mg/m² IV * L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV * 5-FU bolus 400 mg/m² IV * 5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles.
Overall Study STARTED	18
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy + Cetuximab * Cetuximab 500 mg/m² IV * Oxaliplatine 85 mg/m² IV * L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV * 5-FU bolus 400 mg/m² IV * 5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles.
Overall Study Protocol Violation	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy + Cetuximab n=14 Participants * Cetuximab 500 mg/m² IV * Oxaliplatine 85 mg/m² IV * L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV * 5-FU bolus 400 mg/m² IV * 5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles.
Age, Continuous	61.9 years STANDARD_DEVIATION 5.1 • n=14 Participants
Sex: Female, Male Female	4 Participants n=14 Participants
Sex: Female, Male Male	10 Participants n=14 Participants
Region of Enrollment France	14 participants n=14 Participants

PRIMARY outcome

Timeframe: Since surgery, up to 5 years

Outcome measures

Outcome measures
Measure	Chemotherapy + Cetuximab n=14 Participants * Cetuximab 500 mg/m² IV * Oxaliplatine 85 mg/m² IV * L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV * 5-FU bolus 400 mg/m² IV * 5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles.
Median Progression-free Survival (PFS) Time	12.2 months Interval 6.5 to 17.3

SECONDARY outcome

Timeframe: from the date of surgery up to 30 days

Rate of deaths observed within 30 days of surgery

Outcome measures

Outcome measures
Measure	Chemotherapy + Cetuximab n=14 Participants * Cetuximab 500 mg/m² IV * Oxaliplatine 85 mg/m² IV * L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV * 5-FU bolus 400 mg/m² IV * 5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles.
30-day Mortality Rate	0 Participants

SECONDARY outcome

Timeframe: from the date of surgery up to 30 days

Outcome measures

Outcome measures
Measure	Chemotherapy + Cetuximab n=14 Participants * Cetuximab 500 mg/m² IV * Oxaliplatine 85 mg/m² IV * L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV * 5-FU bolus 400 mg/m² IV * 5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles.
Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery	0.93 adverse events Interval 0.0 to 3.7

SECONDARY outcome

Timeframe: from surgery, up to five years.

OS is the delay between surgery and death

Outcome measures

Outcome measures
Measure	Chemotherapy + Cetuximab n=14 Participants * Cetuximab 500 mg/m² IV * Oxaliplatine 85 mg/m² IV * L-folinique Acid 200 mg/m² (or 400 mg/m² for DL) IV * 5-FU bolus 400 mg/m² IV * 5-FU continu 2400 mg/m² IV. One cycle = 14 days. Up to 12 cycles.
Overall Survival (OS) Time	41.5 months Interval 18.4 to 60.0

Adverse Events

Chemotherapy + Cetuximab

Serious events: 6 serious events

Other events: 14 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy + Cetuximab n=14 participants at risk cetuximab fluorouracil leucovorin calcium oxaliplatin adjuvant therapy therapeutic conventional surgery
Vascular disorders Vascular disorders - Other	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
General disorders General disorders and administration site conditions - Other	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Renal and urinary disorders Urinary fistula	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Immune system disorders Anaphylaxis	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Gastrointestinal disorders Gastrointestinal disorders - Other	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Injury, poisoning and procedural complications Intraoperative gastrointestinal injury	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Gastrointestinal disorders Vomiting	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,

Other adverse events

Other adverse events
Measure	Chemotherapy + Cetuximab n=14 participants at risk cetuximab fluorouracil leucovorin calcium oxaliplatin adjuvant therapy therapeutic conventional surgery
Immune system disorders Allergic reaction	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Blood and lymphatic system disorders Anemia	21.4% 3/14 • Number of events 3 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Investigations White blood cell decreased	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Investigations Neutrophil count decreased	21.4% 3/14 • Number of events 4 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Investigations Platelet count decreased	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Vascular disorders Hypotension	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
General disorders General disorders and administration site conditions - Other	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
General disorders Fatigue	71.4% 10/14 • Number of events 10 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
General disorders Fever	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
General disorders Chills	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Investigations Weight loss	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Injury, poisoning and procedural complications burn	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	50.0% 7/14 • Number of events 7 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Skin and subcutaneous tissue disorders Dry skin	28.6% 4/14 • Number of events 4 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Vascular disorders Flushing	28.6% 4/14 • Number of events 4 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
General disorders Injection site reaction	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Skin and subcutaneous tissue disorders Rash maculo-papular	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Skin and subcutaneous tissue disorders Rash acneiform	50.0% 7/14 • Number of events 7 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	50.0% 7/14 • Number of events 7 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Skin and subcutaneous tissue disorders Urticaria	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Vascular disorders Hot flashes	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Metabolism and nutrition disorders Anorexia	21.4% 3/14 • Number of events 3 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Gastrointestinal disorders Gastritis	64.3% 9/14 • Number of events 10 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Gastrointestinal disorders Small intestinal mucositis	28.6% 4/14 • Number of events 4 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Gastrointestinal disorders Nausea	21.4% 3/14 • Number of events 3 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Nervous system disorders Dysgeusia	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Gastrointestinal disorders Vomiting	28.6% 4/14 • Number of events 5 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
General disorders Edema limbs	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	7.1% 1/14 • Number of events 3 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Musculoskeletal and connective tissue disorders Trismus	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Nervous system disorders Peripheral sensory neuropathy	92.9% 13/14 • Number of events 16 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
General disorders Pain	14.3% 2/14 • Number of events 2 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
General disorders Pain, other	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Reproductive system and breast disorders Vaginal discharge	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	7.1% 1/14 • Number of events 1 • from surgery, up to 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term,

Additional Information

Pr Simone Mathoulin-Pélissier

Institut Bergonié

Phone: 0556333333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place