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

Not Recruiting

Trial ID: NCT04380337


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.

Official Title

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

Stanford Investigator(s)

Erqi Pollom
Erqi Pollom

Associate Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery

Vipul Sheth
Vipul Sheth

Assistant Professor of Radiology (Body MRI)

John V. Gahagan, MD, FACS, FASCRS
John V. Gahagan, MD, FACS, FASCRS

Clinical Assistant Professor, Surgery - General Surgery


Inclusion Criteria:

   - 1. Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma
   of rectum requiring total mesorectal excision as deemed by multidisciplinary

   - 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:

      - 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

      - 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

   - 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

Exclusion Criteria:

   - 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.

   - 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).



drug: FOLFOX regimen

drug: XELOX

radiation: IMRT

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Eleanor Brown

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