Chemo-Radiation for Rectal Cancer

Overseen By Eleanor Brown

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Antibiotics, Antiretrovirals, Investigational agents, others

Disqualifiers: Infections, Heart failure, Angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of chemotherapy and radiotherapy to determine if it can safely preserve the organ and improve the quality of life for people with rectal cancer. The study aims to discover if these treatments together can serve as an alternative to surgery. Individuals with a confirmed diagnosis of rectal cancer who have been advised to undergo surgery might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments FOLFOXIRI, FOLFOX, and XELOX are generally well-tolerated for rectal cancer. Common side effects include nausea, and more serious side effects occur in about half of the patients. However, many patients complete their treatment successfully.

For the radiation part of the treatment, the method used is IMRT (Intensity-Modulated Radiation Therapy). Studies have found that IMRT causes fewer bowel side effects compared to other methods. Most patients manage the treatment well, and very few need to stop because of side effects.

In summary, while side effects can occur, these treatments are manageable for many patients. It is important to discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the chemo-radiation treatment for rectal cancer because it combines innovative techniques that could improve patient outcomes. Unlike the standard approach, which typically involves conventional chemotherapies and surgeries like total mesorectal excision (TME), this treatment uses a combination of advanced radiation therapy (IMRT) and chemotherapy regimens (FOLFOXIRI, FOLFOX, or XELOX) to boost effectiveness. One of the standout features is the potential for an organ preservation approach in patients who respond well, potentially sparing them more invasive surgeries. Additionally, the use of FOLFOXIRI offers a robust chemotherapy option that could enhance tumor shrinkage and control, setting the stage for better long-term results.

What evidence suggests that this trial's treatments could be effective for rectal cancer?

In this trial, participants will receive different treatment combinations to evaluate their effectiveness for rectal cancer. Research has shown that certain chemotherapy treatments, such as FOLFOXIRI, FOLFOX, and XELOX, yield promising results for colorectal cancer. For instance, FOLFOX has been linked to a 23% reduction in cancer recurrence in some cases. Studies also indicate that FOLFOXIRI performs as well as other treatments like XELOX. Regarding radiation, Intensity-Modulated Radiation Therapy (IMRT) causes fewer severe side effects than older methods, making it a potentially safer choice for patients. These treatments aim to improve patient outcomes and help preserve organs in those with rectal cancer. Participants in this trial may receive a combination of these treatments, including radiation and chemotherapy, to assess their effectiveness and safety. ^{1 6 7 8 9}

Who Is on the Research Team?

Erqi L Pollom

Principal Investigator

Stanford Universiy

Are You a Good Fit for This Trial?

Adults with rectal cancer that requires surgery, who can sign consent and have no metastases. They must be in good physical condition (ECOG 0-2), not pregnant or breastfeeding, willing to use contraception, and have adequate organ function. Excluded are those with prior treatments for rectal cancer, other active cancers except certain skin cancers/cervical carcinoma in situ, uncontrolled illnesses, known hypersensitivity to treatment drugs, detectable HIV load or on anti-retroviral therapy.

Inclusion Criteria

I can take care of myself and perform daily activities.

Ability to understand and sign the informed consent document

My organs and bone marrow are functioning well.

Exclusion Criteria

Known HIV-positive patients with detectable viral loads and/or receiving combination anti-retroviral therapy

I am currently being treated for an infection.

I have had radiation or chemotherapy for rectal cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive 6 daily fractions of radiotherapy at 5 Gy per fraction

1 week

Chemotherapy

Participants receive 4 months of FOLFOXIRI chemotherapy

16 weeks

Follow-up

Participants are monitored for clinical complete response and safety

9 months

Long-term Follow-up

Participants are monitored for local regrowth, disease-free survival, colostomy-free survival, and overall survival

24-27 months

What Are the Treatments Tested in This Trial?

Interventions

• FOLFOXIRI
• FOLFOX Regimen
• IMRT
• XELOX

Trial Overview The trial tests if a combination of chemotherapy (FOLFOXIRI) and radiotherapy (IMRT) increases the chance of preserving organs in patients with rectal cancer compared to standard treatment. It also assesses the quality of life after this combined treatment approach.

How Is the Trial Designed?

Group I: Radiation/FOLFOXIRI Experimental Treatment 4 Interventions

Treatment will comprise 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI. Patients who have performance status or conditions that may preclude use of FOLFOXIRI may be treated with FOLFOX or XELOX. Those who achieve a clinical complete response will be considered for organ preservation approach. All other patients will receive standard of care total mesorectal excision (TME).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12384374/

CAPOX vs. FOLFOX for Colorectal Cancer—Real World ... The primary outcomes were rates of Emergency Department visits and/or hospitalizations (ED/H) and overall survival (OS). CAPOX was used less frequently (8.4%) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8045118/

Retrospective Comparison of mFOLFOXIRI With XELOX/SOX ... Our data shows that the rates of pathological response (defined as over two-third affected tumor area) are comparable between the mFOLFOXIRI group with 36.7% ( ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP-24-00492

Three Versus Six Months of Adjuvant Oxaliplatin ... This study showed that outcomes with 3 months of CAPOX were very similar to the conventional 6-month regimen of CAPOX or FOLFOX with regards to ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2303269

Preoperative Treatment of Locally Advanced Rectal Cancer In the FOLFOX group, the most frequent grade 3 or higher toxic effects of neoadjuvant therapy were neutropenia, pain, and hypertension, reported ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S101595842100484X

Comparison between oxaliplatin therapy and capecitabine ... The MOSAIC trial favored FOLFOX over 5-fluorouracil/leucovorin (FU/LV) for stage III colon cancer because of a 23% decrease in recurrence and an increase in 5- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965198/

The Kanagawa Yokohama Colorectal Cancer ... FOLFOXIRI therapy was well tolerated and showed comparable efficacy results, providing potential R0 resection in patients with marginally unresectable locally ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2059702925014206

Neoadjuvant chemotherapy with FOLFOXIRI for high-risk ... The most common adverse event (AE) was nausea (86.1%, 62/72), and grade 3-4 AEs occurred in 37 of 72 patients (51.4%). R0 resection was achieved in 61 of 61 ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1403108

Initial Therapy with FOLFOXIRI and Bevacizumab for ... This phase 3, randomized study showed improved progression-free survival among patients with metastatic colorectal cancer after treatment with ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.21.02628

Final Analysis of 3 Versus 6 Months of Adjuvant Oxaliplatin ... 11; Data Supplement). For patients with high-risk disease, outcomes were similar for 3 and 6 months of treatment with mFOLFOX6 (HR, 1.01; 95% CI ...