Trial Outcomes & Findings for Adjuvant HIPEC in High Risk Colon Cancer (NCT NCT02231086)
NCT ID: NCT02231086
Last Updated: 2021-09-16
Results Overview
Peritoneal recurrence-free survival at 18 months determined by CT and CEA. If CEA was normal and CT did not show any signs of peritoneal metastase at 18 months, a diagnostic laparoscopy was performed in those patients who consented to this intervention. Complete peritoneal staging was performed during laparoscopy, and biopsies were taken from suspicious lesions. If no peritoneal lesions were seen or biopsies were negative, this indicated that the patient was free from peritoneal recurrence.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
204 participants
Primary outcome timeframe
18 months
Results posted on
2021-09-16
Participant Flow
Participant milestones
| Measure |
Standard Adjuvant Systemic Chemotherapy
Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.
Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms.
|
Adjuvant HIPEC (Open/Laparoscopic)
Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (\<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis fluid
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
COMPLETED
|
63
|
65
|
|
Overall Study
NOT COMPLETED
|
39
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Adjuvant Systemic Chemotherapy
n=102 Participants
Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.
Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms.
|
Adjuvant HIPEC (Open/Laparoscopic)
n=100 Participants
Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (\<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis flui
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=202 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=102 Participants
|
67 Participants
n=100 Participants
|
134 Participants
n=202 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=102 Participants
|
33 Participants
n=100 Participants
|
68 Participants
n=202 Participants
|
|
Age, Continuous
|
61 years
n=102 Participants
|
61.5 years
n=100 Participants
|
61 years
n=202 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=102 Participants
|
47 Participants
n=100 Participants
|
97 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=102 Participants
|
53 Participants
n=100 Participants
|
105 Participants
n=202 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
102 Participants
n=102 Participants
|
100 Participants
n=100 Participants
|
202 Participants
n=202 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPeritoneal recurrence-free survival at 18 months determined by CT and CEA. If CEA was normal and CT did not show any signs of peritoneal metastase at 18 months, a diagnostic laparoscopy was performed in those patients who consented to this intervention. Complete peritoneal staging was performed during laparoscopy, and biopsies were taken from suspicious lesions. If no peritoneal lesions were seen or biopsies were negative, this indicated that the patient was free from peritoneal recurrence.
Outcome measures
| Measure |
Standard Adjuvant Systemic Chemotherapy
n=102 Participants
Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.
Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms.
|
Adjuvant HIPEC (Open/Laparoscopic)
n=100 Participants
Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (\<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis fluid
|
|---|---|---|
|
Peritoneal Recurrence Free Survival at 18 Months
|
79 participants
|
80 participants
|
SECONDARY outcome
Timeframe: 30 days after adjuvant HIPECPopulation: Only measured in experimental group
Toxicity directly related to adjuvant HIPEC included 30-day complication rate, re-intervention rate, and re-admission rate.
Outcome measures
| Measure |
Standard Adjuvant Systemic Chemotherapy
Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.
Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms.
|
Adjuvant HIPEC (Open/Laparoscopic)
n=87 Participants
Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (\<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis fluid
|
|---|---|---|
|
Treatment Related Toxicity of Adjuvant HIPEC
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 10 weeksHospital stay for simultaneous and staged HIPEC, either open or laparoscopic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsThe presence or absence of peritoneal metastasis on CT-scan will be compared to the findings during diagnostic laparoscopy, histological biopsy or fine needle aspiration cytology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPatterns of dissemination (peritoneal plus or minus distant metastases).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDisease-free survival.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOverall survival.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsQuality of life questionnaire survey 5- year follow-up.
Outcome measures
Outcome data not reported
Adverse Events
Standard Adjuvant Systemic Chemotherapy
Serious events: 46 serious events
Other events: 102 other events
Deaths: 0 deaths
Adjuvant HIPEC (Open/Laparoscopic)
Serious events: 95 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Adjuvant Systemic Chemotherapy
n=102 participants at risk
Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.
Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms.
|
Adjuvant HIPEC (Open/Laparoscopic)
n=100 participants at risk
Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (\<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis flui
|
|---|---|---|
|
Surgical and medical procedures
Anastomotic leakage
|
0.00%
0/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
2.0%
2/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Surgical and medical procedures
wound infection
|
3.9%
4/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
7.0%
7/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Gastrointestinal disorders
Obstructive ileus
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
3.0%
3/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Gastrointestinal disorders
Paralytic ileus
|
3.9%
4/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
5.0%
5/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Gastrointestinal disorders
Gastroparesis
|
7.8%
8/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
15.0%
15/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Infections and infestations
abscess
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
3.0%
3/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
3.0%
3/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Nervous system disorders
delirium
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
4.0%
4/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Infections and infestations
line sepsis
|
0.00%
0/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
1.0%
1/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Blood and lymphatic system disorders
venous thrombosis
|
0.00%
0/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
1.0%
1/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
4.0%
4/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Metabolism and nutrition disorders
Electrolyte disorder
|
5.9%
6/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
8.0%
8/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Metabolism and nutrition disorders
parenteral feeding
|
8.8%
9/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
22.0%
22/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Renal and urinary disorders
dehydration
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
1.0%
1/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Surgical and medical procedures
colonic stenosis
|
0.00%
0/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
1.0%
1/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
General disorders
cardiopulmonary resuscitation
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
0.00%
0/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
2.0%
2/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
2.0%
2/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Cardiac disorders
cardiac
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
2.0%
2/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Renal and urinary disorders
urologic
|
2.0%
2/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
8.0%
8/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Reproductive system and breast disorders
ovarian cyst
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
0.00%
0/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Surgical and medical procedures
gastric perforation
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
0.00%
0/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
nodal metastasis
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
1.0%
1/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Injury, poisoning and procedural complications
chemical peritonitis
|
0.98%
1/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
1.0%
1/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Injury, poisoning and procedural complications
encapsulating peritoneal sclerosis
|
0.00%
0/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
1.0%
1/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
Other adverse events
| Measure |
Standard Adjuvant Systemic Chemotherapy
n=102 participants at risk
Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.
Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms.
|
Adjuvant HIPEC (Open/Laparoscopic)
n=100 participants at risk
Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (\<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis flui
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
71.6%
73/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
68.0%
68/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Gastrointestinal disorders
vomiting
|
23.5%
24/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
27.0%
27/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Nervous system disorders
peripheral sensible neuropathy
|
71.6%
73/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
68.0%
68/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Gastrointestinal disorders
mucositis
|
19.6%
20/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
13.0%
13/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
General disorders
fatigue
|
56.9%
58/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
58.0%
58/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
|
Metabolism and nutrition disorders
anorexia
|
19.6%
20/102 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
13.0%
13/100 • All postoperative complications after resection of the primary tumor and after adjuvant HIPEC, as well as adverse events occuring during adjuvant chemotherapy were collected, until 30 days after last trial related intervention, for an average of 2 years.
We used standard definitions for AE and SAE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place