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Chemotherapy
FOLFOX Regimen for Rectal Cancer
Phase 2
Waitlist Available
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have normal organ and marrow function as defined below: Leukocytes > 3,000/mcL, Absolute neutrophil count > 1,500/mcL, Platelets > 100,000/mcL, Total bilirubin < 1.5 times ULN, AST/ALT (SGOT/SGPT) < 3 times institutional normal limits, Creatinine < 1.5 times ULN OR Creatinine clearance > 60 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal, Ability to understand and willingness to sign a written informed consent and HIPAA consent document
No prior therapy for rectal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing whether giving chemotherapy before surgery and then radiation afterwards can help people with early stage, low rectal adenocarcinoma.
Who is the study for?
This trial is for adults over 18 with early stage, low rectal adenocarcinoma who haven't had treatment for it before. They must be in good health with normal organ and marrow function and not pregnant or breastfeeding. People with certain high-risk tumors, previous malignancies needing systemic therapy within the last 3 years, HIV on antiretroviral therapy, or other serious illnesses are excluded.Check my eligibility
What is being tested?
The study tests a neoadjuvant chemotherapy regimen called FOLFOX followed by local excision and post-operative chemoradiotherapy to see if patients can avoid more invasive surgery. The success of this approach will be measured by the number of patients able to undergo successful local excision without disease progression.See study design
What are the potential side effects?
FOLFOX may cause side effects like nausea, fatigue, nerve damage (neuropathy), low blood cell counts increasing infection risk, allergic reactions, and diarrhea. Post-operative chemoradiotherapy can also lead to similar side effects along with skin irritation from radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not received any treatment for rectal cancer.
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I am fully active or can carry out light work.
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I am older than 18 years.
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My cancer is a type of rectal cancer confirmed by tests and is located very low in the rectum.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients whose tumor can be resected by local excision with negative margins
Secondary outcome measures
Disease-free survival (DFS) of patients
Number of patients with improved bowel function in patients treated with organ preserving approach for early stage low rectal cancer before and after therapy
Number of patients with improved health-related quality of life treated with organ preserving approach for early stage low rectal cancer before and after therapy
+2 moreSide effects data
From 2013 Phase 3 trial • 1183 Patients • NCT0036401360%
Diarrhoea
54%
Neutropenia
52%
Rash
45%
Nausea
34%
Fatigue
34%
Anorexia
32%
Dermatitis acneiform
31%
Paraesthesia
30%
Vomiting
30%
Hypomagnesaemia
29%
Pyrexia
27%
Abdominal pain
26%
Constipation
24%
Mucosal inflammation
24%
Stomatitis
23%
Asthenia
22%
Pruritus
21%
Dry skin
21%
Paronychia
20%
Thrombocytopenia
20%
Hypokalaemia
19%
Neuropathy peripheral
18%
Conjunctivitis
17%
Weight decreased
16%
Erythema
15%
Skin fissures
14%
Alopecia
14%
Anaemia
14%
Epistaxis
14%
Insomnia
13%
Dysgeusia
13%
Peripheral sensory neuropathy
13%
Acne
11%
Back pain
11%
Dyspepsia
10%
Oedema peripheral
9%
Dyspnoea
9%
Palmar-plantar erythrodysaesthesia syndrome
9%
Cough
8%
Abdominal pain upper
8%
Nail disorder
8%
Leukopenia
8%
Pain in extremity
8%
Anxiety
6%
Dysaesthesia
6%
Dizziness
6%
Headache
6%
Urinary tract infection
6%
Depression
5%
Dehydration
5%
Hypocalcaemia
5%
Dry mouth
5%
Nasopharyngitis
4%
Lacrimation increased
4%
Lethargy
4%
Hypertension
3%
Febrile neutropenia
3%
Intestinal obstruction
2%
Sepsis
2%
Colorectal cancer metastatic
2%
Pulmonary embolism
2%
Deep vein thrombosis
2%
Pneumonia
1%
Chest pain
1%
Gastrointestinal haemorrhage
1%
Intestinal perforation
1%
Cerebrovascular accident
1%
Confusional state
1%
Renal failure acute
1%
Atrial fibrillation
1%
Small intestinal obstruction
1%
General physical health deterioration
1%
Catheter related infection
1%
Hepatic failure
1%
Renal failure
1%
Hypotension
1%
Ileus
1%
Hypersensitivity
1%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Panitumumab Plus FOLFOX
FOLFOX Alone
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant chemotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFOX regimen
2009
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
228 Previous Clinical Trials
37,611 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot receive FOLFOX chemotherapy and pelvic radiation due to health reasons.My T1 tumor is larger than 4 cm, has lymphovascular invasion, or is not well differentiated.My rectal cancer has spread to my lymph nodes.I have had chemotherapy for another cancer within the last 3 years.I am HIV-positive and not on antiretroviral therapy.My cancer is in an early stage and hasn't spread to my lymph nodes.I have not received any treatment for rectal cancer.You are currently participating in another study with an experimental treatment.I am fully active or can carry out light work.I am older than 18 years.I haven't had any cancer treatments in the last 3 years.My T3 tumor does not extend significantly or predict a positive margin.You had an allergic reaction in the past to a similar drug or substance as the ones being used in this study.I have had radiation therapy to my pelvic area before.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My cancer is a type of rectal cancer confirmed by tests and is located very low in the rectum.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant chemotherapy
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 of the dangers associated with FOLFOX regimen?
"The FOLFOX regimen was given a 2 because, while there is evidence of its safety, the efficacy of this medical intervention has not yet been tested."
Answered by AI
How many individuals are currently enrolled in this research project?
"That is correct, the listing on clinicaltrials.gov says that this trial is presently looking for volunteers. This particular study was first posted on May 11th, 2018 and updated as recently as April 1st, 2022. They are hoping to enroll 19 patients from a single location."
Answered by AI
Are there any slots left for new volunteers in this experiment?
"Yes. The clinical trial is recruiting patients, as indicated by the information available on clinicaltrials.gov. This specific trial was posted on May 11th, 2018 and updated April 1st, 2022. They are currently seeking 19 individuals at a single site."
Answered by AI
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