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IVLP with Oxaliplatin for Colorectal Cancer Spread to Lungs

Phase 1
Recruiting
Led By Marcelo K Cypel, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Colorectal Carcinoma
ECOG 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new way to deliver chemotherapy to the lungs during surgery, potentially avoiding side effects to other organs. Participants will get oxaliplatin and be monitored for safety, with doses increased until severe but temporary side effects are seen.

Who is the study for?
This trial is for people under 71 with colorectal cancer that has spread to both lungs but not beyond, except possibly the liver. They should be relatively fit (ECOG 0-2) and have at least three lung lesions. It's not for those with a history of severe lung disease, heart issues, or who've had high doses of oxaliplatin before.Check my eligibility
What is being tested?
The study tests a new method called IVLP where chemotherapy (oxaliplatin) is delivered directly into one lung during surgery to target cancer cells while minimizing harm to other organs. The dose starts low and increases until it causes serious but temporary side effects.See study design
What are the potential side effects?
Side effects from oxaliplatin via IVLP can include reactions specific to the infused lung such as inflammation or damage, general chemotherapy-related issues like nausea, nerve sensitivity changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with colorectal cancer.
Select...
I am able to care for myself and move around.
Select...
I am 70 years old or younger.
Select...
My cancer has spread to both lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lung
Secondary outcome measures
Incidence of ICU admission
Incidence of mechanical ventilation
Incidence of pneumonia after procedure
+1 more

Side effects data

From 2016 Phase 4 trial • 128 Patients • NCT01588990
68%
Nausea
63%
Neuropathy peripheral
63%
Fatigue
55%
Diarrhoea
40%
Constipation
31%
Abdominal pain
30%
Palmar-plantar erythrodysaesthesia syndrome
28%
Vomiting
25%
Neutropenia
24%
Mucosal inflammation
23%
Epistaxis
22%
Decreased appetite
20%
Alopecia
20%
Insomnia
20%
Paraesthesia
20%
Gastrooesophageal reflux disease
19%
Headache
18%
Hypertension
17%
Stomatitis
17%
Back pain
16%
Urinary tract infection
16%
Rash
16%
Dysgeusia
14%
Upper respiratory tract infection
14%
Pain in extremity
13%
Mouth ulceration
13%
Thrombocytopenia
13%
Arthralgia
12%
Anaemia
12%
Dysaesthesia
11%
Weight decreased
11%
Oedema peripheral
11%
Musculoskeletal pain
10%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Dysphonia
9%
Depression
9%
Pyrexia
8%
Proteinuria
8%
Fall
8%
Dry skin
8%
Anxiety
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Dehydration
6%
Oropharyngeal pain
6%
Rhinorrhoea
6%
Non-cardiac chest pain
5%
Hypoalbuminaemia
5%
Nail disorder
5%
Intestinal obstruction
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Gastroenteritis
2%
Bronchitis
2%
Lower respiratory tract infection
2%
Pneumonia
2%
Small intestinal obstruction
2%
Anal abscess
2%
Flank pain
2%
Renal failure acute
2%
Confusional state
2%
Febrile neutropenia
2%
Angina pectoris
2%
Enterovesical fistula
1%
Clostridium difficile colitis
1%
Infective exacerbation of chronic obstructive airways disease
1%
Muscle abscess
1%
Anal fissure
1%
Gastrointestinal perforation
1%
Infected dermal cyst
1%
Inguinal hernia
1%
Colonic obstruction
1%
Intestinal perforation
1%
Colitis
1%
Ileus
1%
Gastroenteritis viral
1%
Lobar pneumonia
1%
Pharyngitis
1%
Pneumonia streptococcal
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
1%
Wound infection
1%
Infusion related reaction
1%
Procedural site reaction
1%
Cerebrovascular accident
1%
Hemiparesis
1%
Syncope
1%
Rectal perforation
1%
Catheter site pain
1%
Extravasation
1%
Abscess limb
1%
Radius fracture
1%
Hypomagnesaemia
1%
Hypophagia
1%
Haematuria
1%
Hydronephrosis
1%
Urinary incontinence
1%
Pleural effusion
1%
Pleuritic pain
1%
Musculoskeletal chest pain
1%
Procedural pain
1%
Laceration
1%
Gastrointestinal haemorrhage
1%
Large intestinal obstruction
1%
Transient ischaemic attack
1%
Acute psychosis
1%
Pneumonia aspiration
1%
Jugular vein thrombosis
1%
Orthostatic hypotension
1%
Thrombophlebitis superficial
1%
Device related infection
1%
Ear infection
1%
Enterocolitis infectious
1%
Eyelid infection
1%
Gangrene
1%
Pilonidal cyst
1%
Gastritis
1%
Visual impairment
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab: Phase A and Phase B

Trial Design

1Treatment groups
Experimental Treatment
Group I: IVLP in single lungExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,464 Previous Clinical Trials
483,591 Total Patients Enrolled
Marcelo K Cypel, MDPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

IVLP in single lung Clinical Trial Eligibility Overview. Trial Name: NCT05611034 — Phase 1
Lung Cancer Research Study Groups: IVLP in single lung
Lung Cancer Clinical Trial 2023: IVLP in single lung Highlights & Side Effects. Trial Name: NCT05611034 — Phase 1
IVLP in single lung 2023 Treatment Timeline for Medical Study. Trial Name: NCT05611034 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any criteria that would disqualify individuals from taking part in this experiment?

"This clinical study is accepting approximately 10 participants with a diagnosis of colorectal cancer, aged between 18 and 70."

Answered by AI

What potential risks do patients face when undergoing Intravenous Lung Lavage Procedure (IVLP) on a single lung?

"Our experts at Power rated the safety of IVLP in single lung as a 1 due to its status as an early-stage trial, which suggests there is limited supporting evidence for efficacy and security."

Answered by AI

Does this research protocol accept individuals aged fifty or above?

"As detailed in the inclusion criteria, only individuals aged 18 to 70 can join this clinical trial. In comparison, there are 67 trials available for people under 18 and 1650 studies open to those over 65."

Answered by AI

How many participants are involved in this experiment?

"Affirmative. According to the information posted on clinicaltrials.gov, this trial is actively recruiting subjects and was initially published in February of 2023 with a subsequent update occurring in March 2021. It requires 10 participants from one medical site for completion."

Answered by AI

Are there any openings available in this clinical trial?

"Based on clinicallytrials.gov, the research team is actively searching for participants to join this trial which was first announced in February 6th 2023 and recently revised at March 21st 2023."

Answered by AI
~7 spots leftby Jan 2027