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Post-Hepatectomy Chemotherapy for Liver Cancer
Phase 2
Recruiting
Led By Timothy Newhook
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must receive ≥ 4 cycles of preoperative chemotherapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is looking at using ctDNA to see if it can help predict if a patient is at high or low risk for their cancer coming back after surgery.
Who is the study for?
This trial is for adults over 18 with colorectal liver metastases (CLM) who have had or will have their primary cancer removed and plan to undergo surgery with the intent to cure. They must have completed at least 4 cycles of specific preoperative chemotherapy between July 2021 and December 2023. Pregnant women, patients with other active cancers needing treatment, those unable to receive post-surgery chemo, or unwilling/unable to provide blood samples for ctDNA testing are excluded.Check my eligibility
What is being tested?
The study tests if circulating tumor DNA (ctDNA) can predict early disease recurrence after surgical removal of CLM. It aims to see whether detecting ctDNA helps classify patients into high or low risk for cancer coming back, which could guide further therapy after surgery. Drugs involved include Oxaliplatin, Leucovorin, Fluorouracil (5-FU), Irinotecan, Capecitabine, and Bevacizumab.See study design
What are the potential side effects?
Potential side effects from the drugs may include nerve damage from Oxaliplatin; mouth sores and digestive issues from Fluorouracil; diarrhea and fatigue from Irinotecan; hand-foot syndrome and diarrhea from Capecitabine; increased bleeding or wound healing complications from Bevacizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed at least 4 rounds of chemotherapy before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy
Side effects data
From 2016 Phase 4 trial • 128 Patients • NCT0158899068%
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%
Paraesthesia
20%
Insomnia
20%
Alopecia
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%
Fall
8%
Anxiety
8%
Dry skin
8%
Proteinuria
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Oropharyngeal pain
6%
Rhinorrhoea
6%
Dehydration
6%
Non-cardiac chest pain
5%
Intestinal obstruction
5%
Hypoalbuminaemia
5%
Nail disorder
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%
Infective exacerbation of chronic obstructive airways disease
1%
Anal fissure
1%
Intestinal perforation
1%
Gastrointestinal perforation
1%
Clostridium difficile colitis
1%
Infected dermal cyst
1%
Colonic obstruction
1%
Inguinal hernia
1%
Muscle abscess
1%
Ileus
1%
Gastroenteritis viral
1%
Colitis
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
2Treatment groups
Experimental Treatment
Group I: ctDNA (Low Risk)Experimental Treatment2 Interventions
Will receive less intense chemotherapy, such as capecitabine or 5-fluorouracil.
Group II: ctDNA (High Risk)Experimental Treatment6 Interventions
Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX [5-fluorouracil, leucovorin and oxaliplatin] or FOLFIRI [5-fluorouracil, leucovorin and irinotecan] with or without bevacizumab)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~5730
Oxaliplatin
2011
Completed Phase 4
~2560
5-FLUOROURACIL
2007
Completed Phase 3
~270
Irinotecan
2017
Completed Phase 4
~2680
Capecitabine
2013
Completed Phase 3
~3420
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,276 Total Patients Enrolled
Timothy NewhookPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18, have cancer in my liver from another place, and will have surgery to remove it after chemotherapy.I do not have any other cancers needing treatment.I cannot have or am not planning to have chemotherapy after surgery.I am currently pregnant.I cannot or do not want to have blood tests for cancer DNA.My primary colorectal tumor has not been removed.I have completed at least 4 rounds of chemotherapy before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: ctDNA (High Risk)
- Group 2: ctDNA (Low Risk)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some common applications for Leucovorin?
"Leucovorin is indicated for the treatment of small cell lung cancer, though it can also help patients with rectal carcinoma, colorectal carcinoma, and sarcoma."
Answered by AI
Has the US Food and Drug Administration cleared leucovorin for use?
"While there is some data supporting Leucovorin's safety, it did not receive a higher score because Phase 2 trials lack evidence of efficacy."
Answered by AI
Are new patients being recruited for this experiment?
"That is correct. The listing on clinicaltrials.gov makes it clear that this study is still recruiting patients. This trial was first posted on April 26th, 2022 and does not have an end date listed. They are looking for a total of 120 people to participate at 1 location."
Answered by AI
What similar research has been conducted using Leucovorin?
"Currently, Leucovorin is being trialed in 1157 ongoing clinical trials, with 342 of those research projects in their third phase. Most of the Guangzhou, Guangdong based trials are running concurrently. Across 47365 locations, leucovorin clinical trials are underway."
Answered by AI
How many test subjects are included in this experiment?
"The listings on clinicaltrials.gov show that this study is open for recruitment and has been since 4/26/2022. The trial location is currently seeking 120 patients in total."
Answered by AI
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