Chemotherapy + Radiation for Rectal Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Virginia Commonwealth University
Disqualifiers: Cardiac disease, Infection, Inflammatory bowel, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment mFOLFOX and short-course radiation therapy for rectal cancer?
Research shows that using short-course radiation therapy followed by mFOLFOX chemotherapy can improve local control of rectal cancer and maintain quality of life for patients. This combination has been effective in managing rectal cancer, even in cases with liver-only metastases.
12345Is the combination of chemotherapy and radiation therapy safe for rectal cancer?
Studies have shown that the combination of mFOLFOX chemotherapy and short-course radiation therapy is generally safe for patients with rectal cancer, with research focusing on both quality of life and safety outcomes. Some studies also report on early side effects, which are important for understanding the treatment's safety profile.
13678How is the treatment of mFOLFOX and short-course radiation therapy unique for rectal cancer?
This treatment combines a short-course radiation therapy (5 sessions of 5 Gy each) with mFOLFOX chemotherapy before surgery, which is different from the standard long-course chemoradiotherapy. It aims to reduce treatment time and improve patient tolerance while maintaining effectiveness.
125910Eligibility Criteria
This trial is for adults with resectable rectal cancer, without distant metastases. Participants must have adequate organ function and no serious recent illnesses or surgeries. They should not be pregnant or breastfeeding and must agree to use birth control during the study.Inclusion Criteria
I am fully active and can carry on all pre-disease activities without restriction.
My cancer is in an advanced local stage but hasn't spread to distant parts.
I was diagnosed with rectal cancer in the last 3 months.
+12 more
Exclusion Criteria
My cancer has spread to distant parts of my body.
You have a health, mental, or social condition that may make it more risky for you to participate in the study or make it difficult for you to follow the study's requirements.
I have liver problems causing jaundice or blood clotting issues.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Chemotherapy
Participants receive 4 cycles of systemic chemotherapy with mFOLFOX6 before CRT starts
8 weeks
4 visits (in-person)
Radiation
Participants undergo short-course pelvic IMRT with concurrent continuous infusion of 5-FU
1 week
5 visits (in-person)
Consolidation Chemotherapy
Participants receive 4 additional cycles of systemic chemotherapy with mFOLFOX6 after CRT ends
8 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 years
Participant Groups
The trial tests a combination of chemotherapy (mFOLFOX) and short-course radiation therapy as initial treatment before surgery in patients with rectal cancer. It's designed to see if this approach is effective in treating the disease.
1Treatment groups
Experimental Treatment
Group I: Concurrent Chemotherapy/ Radiation TherapyExperimental Treatment2 Interventions
5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) four 14-day cycles will be given before CRT starts. Pelvic Intensity-modulated radiation therapy (IMRT): 25 Gy in 5 fractions over 5 days + Continuous infusion 5-fluorouracil (5-FU) for 4 days (96 hours) followed by four 14-day cycles of (mFOLFOX6) to be given after CRT ends.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Virginia Commonwealth University Massey Cancer CenterRichmond, VA
Virginia Cancer InstituteRichmond, VA
VCU Community Memorial HealthcenterSouth Hill, VA
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Who Is Running the Clinical Trial?
Virginia Commonwealth UniversityLead Sponsor
References
Quality of Life Outcomes From a Phase 2 Trial of Short-Course Radiation Therapy Followed by FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer. [2022]A prospective phase 2 trial of short-course (SC) radiation therapy (RT) with 25 Gy over 5 fractions, followed by 4 cycles of 5-fluorouracil, oxaliplatin, and leucovorin (mFOLFOX6) before surgery was recently completed at our institution. We present here the patient-reported quality of life (QOL) outcomes from this trial.
Neoadjuvant Short-Course Radiation Therapy for Rectal Cancer: Trends and Controversies. [2019]For patients with locally advanced rectal cancer, neoadjuvant hypofractionated short-course radiation remains an underutilized regimen in the USA. We review the current clinical literature highlighting the relative merits of short-course radiation, along with modern neoadjuvant strategies that incorporate its use.
A phase II study of preoperative mFOLFOX6 with short-course radiotherapy in patients with locally advanced rectal cancer and liver-only metastasis. [2022]To evaluate the efficacy and safety of upfront mFOLFOX6 followed by short-course radiotherapy (SCRT) and surgery in patients with locally advanced rectal cancer and liver-only metastases.
Short-course preoperative radiation therapy for operable rectal cancer. [2019]Short course neoadjuvant radiation has been shown to provide improved local control of rectal cancer in a clinical trial population even in the presence of standardized surgical techniques. However, this use of hypofractionated radiotherapy has been limited in North America owing to concerns over toxicity.
Nonoperative Rectal Cancer Management With Short-Course Radiation Followed by Chemotherapy: A Nonrandomized Control Trial. [2022]Short-course radiation therapy (SCRT) and nonoperative management are emerging paradigms for rectal cancer treatment. This clinical trial is the first to evaluate SCRT followed by chemotherapy as a nonoperative treatment modality.
NRG Oncology/RTOG 0438: A Phase 1 Trial of Highly Conformal Radiation Therapy for Liver Metastases. [2020]This study aimed to determine the feasibility and maximally tolerated dose of hypofractionated, conformal radiation therapy (RT) in patients with liver metastases.
Phase II study of a four-week hypofractionated external beam radiotherapy regimen for prostate cancer: report on acute toxicity. [2018]To evaluate the early side effects of a short course hypofractionated radiotherapy regimen in prostate cancer.
Adjuvant modified FOLFOX-4 in patients with stage III rectum adenocarcinoma. [2017]The aim of this study was to investigate efficacy and toxicity of a modified 5-fluorouracil (5-FU), folinic acid, oxaliplatin (mFOLFOX-4) regimen followed by infusional 5-FU concomitant with radiotherapy for curatively resected stage III rectum adenocarcinoma patients.
Oligometastatic Rectal Adenocarcinoma Treated With Short-Course Radiation Therapy and Chemotherapy With Nonoperative Intent of the Primary for Locoregional Complete Responders. [2022]Nonoperative management with short-course radiation therapy (SCRT) as a component of definitive therapy for oligometastatic rectal cancer has not been previously reported. This single-institution retrospective analysis evaluates treatment with SCRT in combination with chemotherapy (SCRT-CTX) with nonoperative intent for patients with a locoregional clinical complete response (cCR).
[Radiotherapy standard and progress in locally advanced rectal cancer]. [2018]Recently, treatment strategy optimization for neoadjuvant therapy of rectal cancer includes two aspects: (1) Increasing treatment intensity may improve pathological complete response rate, including increasing radiation dose or concurrent chemotherapy intensity, or shifting adjuvant chemotherapy; (2) Short-course radiotherapy or neoadjuvant chemotherapy which can promise treatment efficacy will decrease toxicity and lead to better tolerance. Long-course chemoradiotherapy is the recent treatment standard for locally advanced rectal cancer. NCCN guidelines do not recommend combined chemotherapy in the radiotherapy period. However, it is important for individualized treatment of rectal cancer if appropriate patients who may benefit from the combined concurrent chemotherapy can be selected. Short-course radiotherapy is defined as 5 Gy × 5. It is recommended for T3 or N+ rectal cancer in NCCN guidelines, but not for T4 patients. In ESMO guidelines, stratified patients of intermediate risk by MRI can be treated with either short-course or long-course radiotherapy, but short-course radiotherapy is not recommended for T4 or positive mesorectum fascia (MRF+) patients with high risk. Neoadjuvant chemotherapy incorporated in the neoadjuvant part has been a therapeutic choice in NCCN guidelines. However, It is still unclear whether chemotherapy upfront as a component of neoadjuvant treatment or even completion of chemotherapy before surgery can improve treatment outcome or not. There are phase II( studies focused on this issue and final results are pending.