Is NCT05806931 recruiting in Somerset, NJ?

Yes, NCT05806931 is currently recruiting participants at its Somerset, NJ location. This colorectal cancer clinical trial is actively enrolling qualified participants.

How do I join the colorectal cancer clinical trial in Somerset?

To join this clinical trial in Somerset, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Somerset clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Colorectal Cancer Clinical Trial in Somerset, NJ

About This Colorectal Cancer Study in Somerset

This study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line metastatic colorectal cancer (mCRC)

Sponsor: Rutgers, The State University of New Jersey

Who Can Participate

Inclusion Criteria

Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate.

Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease.

Progression of disease must be documented on the most recent scan.

Presence of measurable disease

RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined).

Age 18 years or older.

ECOG performance status 0-1.

Life expectancy of at least three months.

Participants with adequate organ function:

Absolute neutrophil count (ANC) \> 1.5 x 109/L

Hemoglobin \> 9 g/dL

Platelets (PLT) \> 70 x 109/L

AST/ALT \< 5 x ULN

Albumin within normal limits for institution

Women who are nursing and discontinue nursing prior to enrollment in the program.

Ability to take oral medication (i.e., no feeding tube).

Participant able and willing to comply with study procedures as per protocol.

Participant able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.

Exclusion Criteria

Participants who have previously received TAS-102.

Grade 3 or higher peripheral neuropathy (functional impairment).

Inability to tolerate irinotecan previously (due to uncontrolled diarrhea)

There are no specific exclusions for bevacizumab. Bevacizumab should be given unless there are specific contraindications per the treating investigator, which should be stated. If UPC is \>1.0 (as above) hold bevacizumab until proteinuria resolves and then start bevacizumab.

Symptomatic CNS metastases requiring treatment.

Other active malignancy within the last three years (except for non-melanoma skin cancer or a non-invasive/in situ cancer).

Pregnancy or breast feeding.

Current therapy with other investigational agents.

Active infection with body temperature \> 38°C due to infection.

Major surgery within prior four weeks (the surgical incision should be fully healed prior to drug administration).

Any anticancer therapy within prior two weeks of first dose of study drug.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102.

Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior four weeks.

Grade 3 or higher hypersensitivity reaction to oxaliplatin or irinotecan, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication.

Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Somerset?

Yes, this clinical trial (NCT05806931) has an active research site in Somerset, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Colorectal Cancer Treatment Options in Somerset, NJ

If you're searching for colorectal cancer treatment options in Somerset, NJ, this clinical trial (NCT05806931) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Somerset research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced colorectal cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all colorectal cancer clinical trials near you to find additional studies recruiting in your area.

Colorectal Cancer Clinical Trial in Somerset, NJ

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