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AzTrials

Rectal CancerPhase 2NCT04380337

Organ Preservation Program Using Short-Course Radiation & FOLFOXIRI in Rectal Cancer

A Phase 2 study testing FOLFOXIRI, FOLFOX regimen and XELOX in people with Rectal Cancer, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
FOLFOXIRI, FOLFOX regimen and XELOX
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
21 May 2020to 17 Jan 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of rectum requiring total mesorectal excision as deemed by multidisciplinary evaluation
  • 2.At least 18 years of age
  • 3.For women of childbearing potential or who are not postmenopausal (see Appendix B for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done. Also, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for up to 4 weeks following the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • 4.ECOG 0, 1, or 2
  • 5.Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
  • 6.Patients must have acceptable organ and marrow function as defined below:
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  • Absolute neutrophil count (ANC) >1,500/uL
  • Hg > 8.0 g/dL; if blood transfusion is performed for achieving adequate hemoglobin level, the level should stay above goal for at least 1 week after transfusion
  • Platelets >100,000/uL
  • Total bilirubin <1.5X normal institutional limits
  • aspartate aminotransferase (AST) (SGOT) / alanine aminotransferase (ALT)(SGPT) < 3X upper limit of normal
  • Creatinine <1.5X upper limit of normal or creatinine clearance (CrCL)>50 by Cockcroft-Gault
  • 7 Clinical stage >T2N0 or low T2N0 rectal cancer (AJCC, 8th ed.) including no metastases based on the following diagnostic workup:
  • General history and physical examination with DRE (if deemed appropriate by treating physician) within 45 days prior to enrollment
  • Sigmoidoscopy within 90 days prior to enrollment
  • The following imaging studies are required within 45 days prior to enrollment:
  • CT chest/abdomen/pelvis
  • MRI Pelvis

Who cannot join

  • 1.Prior pelvic RT or chemotherapy for rectal cancer.
  • 2.Upper T2N0 rectal cancers eligible for sphincter-preservation surgery
  • 3.Use of other investigational agents.
  • 4.Ongoing or active infections requiring systemic antibiotic treatment or uncontrolled intercurrent illness including but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • 5.Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with any previous malignancy without evidence of disease for >3 years will be allowed to enter the trial.
  • 6.Known hypersensitivity to 5-FU compounds.
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  • 7.Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. (This applies to women who have experienced menarche and have not undergone successful surgical sterilization or are not postmenopausal).
  • Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients with detectable viral loads and/or receiving combination anti-retroviral therapy are excluded from the study.
  • 8.Primary unresectable rectal cancer (tumor invading adjacent organs and en bloc resection will not achieve negative margins).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94304

Other trials in United States

About this study

Official title: Phase II Trial of Organ Preservation Program Using Short-Course Radiation and FOLFOXIRI for Rectal Cancer (SHORT-FOX)

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.

Read the detailed description

Primary Objective: To assess clinical complete response of an organ preservation approach using short course radiation followed by intensified chemotherapy.

Secondary Objective: To assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach

Conditions
Rectal Cancer
Being tested
FOLFOXIRI, FOLFOX regimen, XELOX, IMRT
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFOXIRIDrug

    Chemotherapy regimen of Oxaliplatin 85mg/m2 , Leucovorin 400 mg/m2 , Irinotecan 165mg/m2 , 5-Fluorouracil

  • FOLFOX regimenDrug

    Chemotherapy regimen of Oxaliplatin 85mg/m2, Leucovorin 400 mg/m2, 5-Fluorouracil 2400mg/m2

  • XELOXDrug

    Chemotherapy regimen of Oxaliplatin 130 mg/m2, Capecitabine 1000mg/m2

  • IMRTRadiation

    Also called Intensity-modulated radiotherapy (IMRT)

    Radiotherapy (5 Gy x 5 fractions) with an additional boost fraction (5 Gy x 1 fraction) delivered sequentially

Study groups in NCT04380337
Study groupRoleWhat they receive
Radiation/FOLFOXIRIExperimentalTreatment 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).
Receives: Drug: FOLFOXIRI; Drug: FOLFOX regimen; Drug: XELOX; Radiation: IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Complete Response (cCR)

    Proportion of patients who achieve a clinical complete response following therapy, expressed as a number and proportion without dispersion.

    Measured: 8 (+/-4 ) weeks following completion of RT and chemotherapy, an average of 9 months

Secondary outcomes (5)

  1. Number of Participants With Toxicity

    Toxicity defined as non-hematologic grade 4 adverse events using CTCAE v5 or higher toxicity at least possibly related to treatment, and assessed up to 3 months after completion of radiotherapy (RT) and chemotherapy.

    Measured: 8 (+/- 4) weeks following completion of RT and chemotherapy, an average of 3 months

  2. Local Regrowth Rate

    Local regrowth is defined as the presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology, expressed as a percentage with its 95% confidence interval.

    Measured: 22 (+/- 2) months following completion of RT and chemotherapy, an average of 24 months (2 years)

  3. Disease Free Survival (DFS)

    DFS defined as the time from the start date of RT to the date of the first documented progression or death due to any cause assessed up to 2 years after completion of chemotherapy. Patients will be censored at the last date of follow-up if lost to follow-up prior to two years, expressed as a median with interquartile range.

    Measured: 22 (+/- 2) months following completion of RT and chemotherapy, an average of 24 months (2 years)

  4. Colostomy-free Survival

    Colostomy-free survival defined as the time from the start date of RT to the date of colostomy or death due to any cause assessed up to 2 years after completion of chemotherapy, expressed as a median with interquartile range. Patients will be censored at the last date of follow-up if lost to follow-up prior to two years.

    Measured: 22 (+/- 2) months following completion of RT and chemotherapy, an average of 24 months (2 years)

  5. Overall Survival (OS)

    OS defined as death from any cause from start date of RT until death, study completion, or loss to follow-up, whichever occurs first. This will be reported as median survival time with interquartile range.

    Measured: 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2020
  2. Study start21 May 2020
  3. Primary completion17 Jan 2024
  4. Study completion17 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04380337
Sponsor's protocol ID
IRB-56027
Other IDs
IRB-56027, COR0019
Status last verified
Feb 2025
First submitted
5 May 2020
Last updated
25 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brown E, Fisher GA Jr, Shelton A, Chang DT, Pollom E. Advancing clinical trial equity through integration of telehealth and decentralized treatment. JNCI Cancer Spectr. 2024 Jul 1;8(4):pkae050. doi: 10.1093/jncics/pkae050.

    PubMed 38902952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOXIRI, FOLFOX regimen and XELOX in people with Rectal Cancer, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Complete Response (cCR) (time frame: 8 (+/-4 ) weeks following completion of RT and chemotherapy, an average of 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04380337, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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