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

NCT ID: NCT04380337

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-21
• Study Completion Date: 2024-01-17

Brief 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. 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation/FOLFOXIRI

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).

Group Type: EXPERIMENTAL

FOLFOXIRI

Intervention Type: DRUG

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

FOLFOX regimen

Intervention Type: DRUG

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

XELOX

Intervention Type: DRUG

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

IMRT

Intervention Type: RADIATION

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

Interventions

FOLFOXIRI

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

Intervention Type: DRUG

FOLFOX regimen

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

Intervention Type: DRUG

XELOX

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

Intervention Type: DRUG

IMRT

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

Intervention Type: RADIATION

Other Intervention Names

Intensity-modulated radiotherapy (IMRT)

Eligibility Criteria

Inclusion Criteria

• 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:

• 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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Erqi Liu Pollom

Associate Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erqi L Pollom

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38902952 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-56027

Identifier Type: OTHER

Identifier Source: secondary_id

COR0019

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-56027

Identifier Type: -

Identifier Source: org_study_id