Chemotherapy vs Chemoradiotherapy for Rectal Cancer
(NEO-RT Trial)
Recruiting in Palo Alto (17 mi)
+56 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Canadian Cancer Trials Group
Disqualifiers: High-risk biopsy, Pelvic nodes, Prior radiation, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?
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 for rectal cancer?
Research shows that using capecitabine (Xeloda) or 5-fluorouracil (5-FU) with radiation can effectively reduce the chance of cancer coming back in rectal cancer patients. These drugs, when combined with radiation, have been found to be as effective as each other, and adding oxaliplatin may improve results further.
12345Is the combination of chemotherapy and radiation generally safe for treating rectal cancer?
The combination of chemotherapy drugs like capecitabine (Xeloda) or 5-fluorouracil (5-FU) with radiation is generally considered safe for treating rectal cancer, with some patients experiencing side effects like diarrhea and low white blood cell counts. These treatments are well-tolerated and have been shown to be effective in reducing cancer recurrence.
12456How does chemoradiotherapy differ from chemotherapy for rectal cancer?
Chemoradiotherapy for rectal cancer combines chemotherapy with radiation therapy, which can enhance the effectiveness of treatment by shrinking tumors before surgery and potentially improving survival rates. This approach often uses oral capecitabine, which is more convenient than the traditional intravenous 5-fluorouracil (5-FU), and has shown similar effectiveness in reducing tumor size and recurrence.
12378Eligibility Criteria
This trial is for adults with mid to low-lying rectal cancer that's suitable for limited surgery, not spread elsewhere (M0), and without certain blood vessel involvement. Patients must be fit for major surgery, able to complete questionnaires in English, French or Spanish, and have no issues with the chemotherapy drugs planned.Inclusion Criteria
Must be accessible for treatment and follow-up
My cancer is at a stage where it cannot be removed through surgery via the anus or is at stage cT2.
I can complete quality of life surveys in English, French, or Spanish.
+11 more
Exclusion Criteria
I have had radiation therapy to my pelvic area before.
Patients with visible pelvic sidewall nodes on MRI
My primary cancer lesion has been surgically removed.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either FOLFOX or CAPOX chemotherapy for up to 12 weeks, or chemotherapy with radiation therapy for up to 6 weeks
6-12 weeks
Surgery
After treatment, surgery is performed based on the study doctor's assessment
Follow-up
Participants are monitored for safety and effectiveness after surgery, with visits every 4 months for 2 years, then every 6 months for an additional year, and annually for 2 more years
5 years
Participant Groups
The study compares two pre-surgery treatments: one group receives only chemotherapy (Fluoruracil, Oxaliplatin, Leucovorin) while the other gets both chemo and radiation therapy followed by limited surgery. The goal is to see if avoiding radiation improves quality of life without affecting treatment response.
2Treatment groups
Active Control
Group I: FOLFOX OR CAPOXActive Control4 Interventions
FOLFOX= Six cycles of modified FOLFOX consisting of leucovorin, oxaliplatin and bolus fluoruracil (optional), infusional fluorouracil.
CAPOX= Capecitabine twice daily for 14 days and Oxaliplatin on day 1
Group II: ChemoRTActive Control3 Interventions
Standard dose of infusional 5-Fluorouracil/capecitabine and radiation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Legacy Meridian Park HospitalTualatin, OR
Cancer Center at Saint Joseph'sPhoenix, AZ
University Medical Center New OrleansNew Orleans, LA
West Michigan Cancer CenterKalamazoo, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Canadian Cancer Trials GroupLead Sponsor
NRG OncologyCollaborator
ECOG-ACRIN Cancer Research GroupCollaborator
Alliance for Clinical Trials in OncologyCollaborator
SWOG Cancer Research NetworkCollaborator
References
Neoadjuvant chemoradiation for rectal cancer: is more better? [2018]Neoadjuvant chemoradiation is now considered the clear preferable adjuvant standard of care in the management of stage II/III rectal cancer. Neoadjuvant fluorouracil (5-FU) plus radiation results in a decrease in local relapse rates and a favorable toxicity profile in comparison with postoperative adjuvant 5-FU plus radiation therapy. Recent nonrandomized comparative studies have shown that capecitabine (Xeloda) plus radiation result in downstaging and pathologic complete responses equivalent to those of 5-FU plus radiation, making this combination an acceptable alternative neoadjuvant treatment. The addition of oxaliplatin (Eloxatin) or irinotecan (Camptosar) to 5-FU or capecitabine concurrently with radiation therapy appears to result in more favorable pathologic responses in phase I/II trials. These combinations should be investigated further in larger phase III studies before they are endorsed in the routine neoadjuvant treatment of rectal cancer. This article will review the progress of chemoradiation over the past 2 decades, current standards of care, and investigational treatments in the neoadjuvant treatment of rectal cancer.
Comparison of protracted infusion 5-fluorouracil and capecitabine in adjuvant chemoradiotherapy for rectal cancer. [2015]5-Fluorouracil-based chemoradiotherapy is the most widely used treatment modality in the adjuvant treatment of rectal cancer. Capecitabine represents a valuable alternative to 5-Fluorouracil in this situation.
A prospective randomized trial comparing intravenous 5-fluorouracil and oral doxifluridine as postoperative adjuvant treatment for advanced rectal cancer. [2022]Postoperative adjuvant chemoradiation treatment after curative resection for rectal cancer was needed to reduce recurrence and improve a survival rate. Intravenous 5-fluorouracil (5-FU) and leucovorin has been a mainstay of chemotherapy, but oral 5-FU derivatives have been shown a comparable antitumor activity. Intravenous 5-FU and oral doxifluridine were compared with respect to therapeutic efficacy, drug toxicity, and quality of life.
Phase II study of capecitabine (Xeloda) and concomitant boost radiotherapy in patients with locally advanced rectal cancer. [2022]The aim of this study was to determine the efficacy of capecitabine (Xeloda), an oral fluoropyrimidine, as a radiosensitizer in the neoadjuvant treatment of locally advanced rectal cancer (LARC).
Retrospective Comparison of mFOLFOXIRI With XELOX/SOX as Neoadjuvant Chemotherapy for Locally Advanced Rectal Cancer. [2021]Neoadjuvant chemotherapy without radiation (NAC) shows favorable outcomes for locally advanced rectal cancer (LARC), however, the optimal regimen has not been determined yet. This study aimed to compare the efficacy and safety of oxaliplatin, irinotecan, folinic acid, and 5-fluorouracil (mFOLFOXIRI) with capecitabine/S-1 and oxaliplatin (XELOX/SOX) in rectal cancer patients.
Capecitabine chemoradiation for rectal cancer after curative surgery. [2015]This study reports the tolerability and feasibility of capecitabine, an oral fluoropyrimidine, chemoradiation as postoperative treatment. Stage II-III rectal cancer patients received 2 cycles of bolus 5-FU (425 mg/m2) and leucovorin (LV) (20 mg/m2) on days 1-5 q3w followed by oral capecitabine (800 mg/m2 bid) continuously during pelvic radiotherapy (total 50.4 Gy). Two additional cycles of 5-FU/LV were finally administered. Forty-one radically resected patients (median age: 61 years) were enrolled. All patients were evaluable for safety. Grade 3 adverse events included: proctitis (n = 3, 7%), diarrhea (n = 5, 12%), and leukopenia (n = 1, 2%). The overall rate of grade 3 diarrhea and leukopenia was 15% (95% confidence interval, 5-29%). Capecitabine chemoradiation in the adjuvant setting is well tolerated and is convenient to administer. These results support the use and further study of capecitabine chemoradiation in radically resected rectal cancer patients.
Comparing pathological complete response rate using oral capecitabine versus infusional 5-fluorouracil with preoperative radiotherapy in rectal cancer treatment. [2018]Infusional 5-fluorouracil (5-FU) has been the standard radiation sensitizer in patients undergoing preoperative long-course chemoradiotherapy (CRT) for locally advanced rectal cancer in Australia. Capecitabine (Xeloda) is an oral 5-FU prodrug of comparable pharmacodynamic activity, currently preferred in place of 5-FU infusion, its established counterpart in neoadjuvant CRT for rectal cancer. The few studies quantifying pathological complete response (pCR) of Xeloda versus 5-FU have produced inconsistent results. We reviewed our own data to determine if the rates of pCR of oral capecitabine were non-inferior to intravenous 5-FU in patients undergoing neoadjuvant CRT for rectal cancer.
Improving chemoradiotherapy in rectal cancer. [2019]The optimal management of rectal cancer remains a major challenge for oncologists. The treatment of stage II/III rectal cancer has historically been associated with a high risk of local recurrence and poor survival, which led to the development of adjuvant treatments in the hope of improving outcomes. The approach to adjuvant therapy for rectal cancer currently varies widely between Europe and the U.S. Postoperative adjuvant chemoradiation is the standard of care in the U.S. In contrast, in Europe, because there is a greater emphasis placed on preoperative imaging, meticulous surgical technique, and accurate pathologic reporting of the circumferential or radial margin, preoperative treatment (radiotherapy and chemoradiation) is used widely. The aims of preoperative radiotherapy and chemoradiation are to facilitate a curative resection (R0) and to increase the chance of performing sphincter-sparing procedures, and, therefore, to improve both survival and quality of life. This article reviews the clinical trials that led to these diverging standards of care. An interesting new approach in chemoradiation is the use of the oral fluoropyrimidine capecitabine as a combination partner for radiotherapy. Preclinical studies have demonstrated that the combination of capecitabine and radiotherapy has highly enhanced antitumor activity. This is most likely attributable to the upregulation of thymidine phosphorylase (the rate-limiting enzyme needed to convert capecitabine to 5-fluorouracil [5-FU]) in tumor cells following radiotherapy. A phase I study has consequently been performed to establish a feasible chemoradiotherapy combination. Capecitabine has the potential to replace bolus or continuous infusion 5-FU as the standard treatment for rectal cancer and offers a potentially enhanced therapeutic ratio. Oral chemotherapy has the additional advantage of simplifying chemoradiation and providing a treatment that is more appealing to patients.