What is the mechanism of action of this treatment?

Common treatments for colorectal cancer include radiotherapy and chemotherapy. Radiotherapy damages the DNA of cancer cells, leading to cell death and modulating the immune response, which can enhance the body's ability to fight cancer. Chemotherapy, such as oxaliplatin-based regimens like FOLFOX, disrupts DNA replication and repair, causing cancer cell death. These mechanisms are important for patients to understand as they explain how treatments target cancer cells and the potential side effects.

What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as chemotherapy and radiotherapy, have several known side effects. Chemotherapy can cause neuropathy, diarrhea, nausea, vomiting, stomatitis, fatigue, and partial alopecia. Radiotherapy, which damages the DNA of cancer cells, can lead to skin irritation, fatigue, and gastrointestinal issues like diarrhea and abdominal pain. Both treatments may also weaken the immune system, increasing the risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer that align with the mechanisms of radiotherapy. Chemotherapy agents such as fluorouracil (5-FU) and oxaliplatin are commonly used, often in combination regimens like FOLFOX (5-FU, leucovorin, and oxaliplatin). Additionally, immunotherapy drugs such as pembrolizumab (Keytruda) and nivolumab (Opdivo), which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells, have been approved for use in certain cases of colorectal cancer, particularly those with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors.

What other types of research exist?

Promising novel alternatives to radiotherapy for colorectal cancer patients in 2024 include: 1) Immunotherapy, particularly immune checkpoint inhibitors like pembrolizumab for patients with dMMR or high TMB tumors. 2) Targeted therapies, such as those involving BRAF or KRAS inhibitors for patients with specific genetic mutations. 3) Investigational therapies, including CAR-T cell therapy and novel combinations of immunotherapy with other agents. These alternatives offer potential benefits in terms of efficacy and safety, and ongoing clinical trials are expected to provide further insights.

← Back to Search

Radiation

Radiotherapy for Rectal Cancer (ROBIN Trial)

N/A

Recruiting

Led By Encouse Golden, M.D., Ph.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1, week 6

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a specific treatment can help the body's defenses fight a type of cancer more effectively. It focuses on patients who usually receive this treatment as part of their care. The study aims to see if the treatment not only targets cancer cells but also helps the body's defenses attack them.

Who is the study for?

Adults over 18 with a specific type of rectal cancer that hasn't spread far or been treated yet. They must be in good health, not pregnant, and willing to use birth control. People can't join if they've had certain treatments before, have more advanced cancer, are on strong immune system drugs, or have other serious health issues.

What is being tested?

The trial is testing how standard short course radiation therapy affects the immune response in rectal cancer patients who will also undergo surgery called Total Mesenteric Excision. It's for those whose cancer hasn't spread too much and aims to understand treatment effects better.

What are the potential side effects?

Short course radiation may cause side effects like skin irritation at the treatment site, fatigue, bowel changes such as diarrhea or discomfort, and possibly bladder symptoms. Surgery risks include bleeding, infection, pain and potential impacts on bowel function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1, week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of research specimens obtained after RT.

Number of research specimens obtained at the time of surgery.

Number of research specimens obtained before RT.

+1 more

Secondary study objectives

Changes in Cellular stress (quantification of reactive Oxygen species (ROS))

Changes in enhancement kinetics from pre-treatment and post-treatment CT will be measured.

Changes in enhancement kinetics from pre-treatment and post-treatment MRI will be measured.

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single cohortExperimental Treatment2 Interventions

Eligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days (fractions) for their localized rectal cancer. Research bloods stool and tissue will be collected at three time points: Baseline, end of radiation therapy and at surgery.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include radiotherapy and chemotherapy. Radiotherapy damages the DNA of cancer cells, leading to cell death and modulating the immune response, which can enhance the body's ability to fight cancer. Chemotherapy, such as oxaliplatin-based regimens like FOLFOX, disrupts DNA replication and repair, causing cancer cell death. These mechanisms are important for patients to understand as they explain how treatments target cancer cells and the potential side effects.