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

38 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the research is to evaluate whether both chemotherapy and radiotherapy can lead to higher rates of clinical complete response leading to organ preservation in human subjects with cancer. The objective is to learn if this treatment approach may safely be used as an alternative to the standard treatment for rectal cancer and to know the quality-of-life in these patients.

Research Team

Erqi L Pollom

Principal Investigator

Stanford Universiy

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+