CLINICAL TRIAL

Capecitabine for Locally Advanced Rectal Carcinoma

High Risk
Metastatic
Stage II
Recruiting · 18+ · All Sexes · Providence, RI

This study is evaluating whether a drug which makes cancer cells more sensitive to radiation therapy may help treat rectal cancer.

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About the trial for Locally Advanced Rectal Carcinoma

Eligible Conditions
Locally Advanced Rectal Carcinoma · Stage IIA Rectal Cancer AJCC v8 · Stage III Rectal Cancer AJCC v8 · Stage IIIB Rectal Cancer AJCC v8 · Stage IIC Rectal Cancer AJCC v8 · Rectal Neoplasms · Stage IIIC Rectal Cancer AJCC v8 · Stage IIIA Rectal Cancer AJCC v8 · Rectal Adenocarcinoma · Stage II Rectal Cancer AJCC v8 · Stage IIB Rectal Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Capecitabine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Capecitabine
DRUG
Ropidoxuridine
DRUG
Radiation Therapy
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
At diagnosis, patients must have had histologically proven adenocarcinoma of the rectum with no evidence of distant metastases
Distance of the lowest tumor margin from the anal verge;
Intent for sphincter sparing or non-sphincter sparing surgical resection according to the primary surgeon;
The majority of the untreated tumor must be < 12 cm from the anal verge or below the peritoneal reflection as determined by the treating surgeon
Distal location (as defined by measurement on magnetic resonance imaging [MRI], endorectal ultrasound [ERUS]/pelvic computed tomography [CT] [with intravenous (IV) contrast] scan or palpable on digital rectal exam [DRE]): cT3-4 =< 5 cm from the anal verge, any N
Bulky: Any cT4 or evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan
High risk for metastatic disease with 4 or more regional lymph nodes (cN2). Clinical Nodal or "cN" status for eligibility includes the total number of nodes (N2 = 4 or more) in the mesorectal and superior rectal stations measuring >= 1.0 cm in any axis on cross sectional or endoscopic imaging. Nodes must measure 1.0 cm or greater to be considered positive for this eligibility requirement
Not a candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy (as planned by the primary surgeon)
Patients must have received 8 cycles of neoadjuvant leucovorin, fluorouracil, and oxaliplatin (mFOLFOX) and must have completed this therapy at least 3 weeks (and no more than 6 weeks) prior to enrollment on this study
Patients must intend to undergo surgical resection of the rectal primary tumor following chemoradiotherapy
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Capecitabine will improve 2 primary outcomes, 5 secondary outcomes, and 2 other outcomes in patients with Locally Advanced Rectal Carcinoma. Measurement will happen over the course of At the time of surgery.

Pathological complete response rate at the maximum-tolerated dose
AT THE TIME OF SURGERY
In rectal cancer, the absence of viable tumor cells in the resection specimen (primary tumor mass, surrounding tissue and lymph nodes, T0 N0 M0) at the time of surgery, termed pathologic complete response. Pathologic complete response determination will be made by the pathologist at the treating institution.
AT THE TIME OF SURGERY
Maximum-tolerated dose
UP TO 38 DAYS
The maximum-tolerated dose is defined as the dose below which 2 or more of 6 patients experience dose-limiting toxicities attributable to ropidoxuridine.
UP TO 38 DAYS
Incidence of dose-limiting toxicities (Part IB)
UP TO 38 DAYS
Assessed by Common Terminology Criteria for Adverse Events version 5 and reached when any two grade 3 treatment-related non-hematologic toxicities or one grade 4 treatment-related hematologic and/or gastrointestinal toxicity are observed in two of the 6 patients enrolled at that dose level.
UP TO 38 DAYS
Percentage of ropidoxuridine incorporation in circulating granulocytes
PRIOR TO ROPIDOXURIDINE DOSE AND AT 30, 60, 120, AND 240 MINUTES AFTER ROPIDOXURIDINE DOSE ON DAY 8, THEN AT 1-2 HOURS AFTER ROPIDOXURIDINE DOSE ON DAYS 21 AND 35
Will correlate these levels with ropidoxuridine plasma pharmacokinetics. Two-sided Fisher's z-test with significance level of 0.05 and power of 80% will be used and the study will reject the null hypothesis (lack of correlation or r0 = 0) if we observe a correlation with r ranging from 0.79 for N = 10 subjects to 0.49 for N = 30 subjects.
PRIOR TO ROPIDOXURIDINE DOSE AND AT 30, 60, 120, AND 240 MINUTES AFTER ROPIDOXURIDINE DOSE ON DAY 8, THEN AT 1-2 HOURS AFTER ROPIDOXURIDINE DOSE ON DAYS 21 AND 35
Neoadjuvant rectal score at the maximum-tolerated dose
AT 6-10 WEEKS FOLLOWING COMPLETION OF THERAPY
Neoadjuvant rectal score is calculated based on the clinical T stage (cT), pathological T (pT) and pN stages as neoadjuvant rectal score = [5pN- 3 (cT- pT) + 12]2 / 9.61.
AT 6-10 WEEKS FOLLOWING COMPLETION OF THERAPY
Change in tissue biomarker levels
BASELINE UP TO 8-12 WEEKS FOLLOWING COMPLETION OF CHEMOTHERAPY
Will be measured on continuous and binary scales will be assessed using Wilcoxon signed rank or McNemar's tests, respectively (two-sided; alpha = 0.05). Associations between therapeutic response and baseline biomarker values or temporal changes in biomarkers will be explored using Fisher's exact tests or Wilcoxon rank sum tests.
BASELINE UP TO 8-12 WEEKS FOLLOWING COMPLETION OF CHEMOTHERAPY
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get locally advanced rectal carcinoma a year in the United States?

About 11,500 individuals will be diagnosed with rectal cancer and 4200 new cases will occur each year. About 4 of every 5 will receive adjuvant chemotherapy, but only 14 of every 1,000 will survive 5 year after diagnosis. The 5 year survival depends on disease stage, and this does appear to be higher than the national average. There is much variation both by disease stage and by surgical resections, which can have strong association with outcome. Patient education is needed to enable patients to make informed decisions about quality of life.

Anonymous Patient Answer

What causes locally advanced rectal carcinoma?

The data on rectal carcinoma in this study indicate that the patient's underlying factors are the most significant contributing factors to local advanced rectal carcinoma onset. Risk factors and preventive strategies should therefore be evaluated for patients presenting early with this condition.

Anonymous Patient Answer

What is locally advanced rectal carcinoma?

We can summarize locally advanced rectal carcinomas are those that have invaded the circumferential (tumor infiltrates into the anal canal lumen), above the anal verge (deeper than 5 cm from the anal verge), the distal aspect of the distal rectum/sigmoid colon, the posterior aspect of levator ani myenterial muscle, the intervesical space, and the superficial surface of the pelvic floor.

Anonymous Patient Answer

What are the signs of locally advanced rectal carcinoma?

More than 20 lesions have been found (6 were found in the rectum and 9 in the anus in patients without local recurrence) (Fig. 2.) On the basis of these findings we have confirmed the relevance of the T staging and the possibility of the existence of distant metastasis.

Anonymous Patient Answer

What are common treatments for locally advanced rectal carcinoma?

Treatment of locally advanced rectal carcinoma is dictated by the location of the tumor and other clinical factors such as local and regional spread, metastases, and treatment technique; the most frequently used treatment is chemoradiation for more than 6 weeks. Chemoradiation has been proven to increase local tumor control; metastases may remain in the resection specimen, so further radiotherapy has been recommended.

Anonymous Patient Answer

Can locally advanced rectal carcinoma be cured?

The present study shows that the survival in patients with locally advanced rectal carcinoma is affected by the degree of nodal involvement and tumor grade. Therefore, a careful follow-up after neoadjuvant chemoradiation is necessary in patients who are candidates for local resection.

Anonymous Patient Answer

Who should consider clinical trials for locally advanced rectal carcinoma?

Local therapy is a strong independent prognostic factor for survival in rectal carcinomas as well as a predictive factor for PFS that should facilitate clinical trials. Patients who will receive targeted therapy should be identified through pretreatment clinical assessment of tumour vascularization and TNM staging, preferably through endorectal ultrasound imaging.

Anonymous Patient Answer

What is capecitabine?

Capecitabine given in doses of 50 or 65 mg/m2/d has shown to be an effective and well tolerated regimen for the treatment of locally advanced carcinoma of the rectum.

Anonymous Patient Answer

Does capecitabine improve quality of life for those with locally advanced rectal carcinoma?

Capecitabine does not appear to improve overall or HRQOL. Although there are no differences between treatment groups in terms of appetite, weight, or diarrhoea, the results of this trial indicate that caution should be taken when considering the use of capecitabine as a single-agent in combination chemotherapy for patients with locally advanced rectal carcinoma. Clinicians can therefore focus on the adverse effects of capecitabine in further trials in this population. However, as it is generally well tolerated, the use of capecitabine or its fluorinated analogues should be reconsidered in the setting of metastatic colorectal carcinoma. This trial is registered with clinicaltrials.gov as NCT01627019.

Anonymous Patient Answer

What are the common side effects of capecitabine?

In a recent study, findings demonstrated that the most common side effects associated with this chemotherapy regimen were gastrointestinal, and that capecitabine did not appear to cause haematological toxicity. The most common side effect was diarrhoea, which occurred in over 40% of patients and was mainly due to nausea or vomiting (n=22 and n=37, respectively, P<0.05). It was very important to administer a standard dose to ensure that patients and caregivers were correctly educated in how to handle and treat this disease. The capecitabine has a higher oral bioavailability than the 5-FU due to its chemical structure and oral administration.

Anonymous Patient Answer

Have there been other clinical trials involving capecitabine?

Results from a recent clinical trial of the present study add further evidence that capecitabine is a highly effective agent in LARC. This result has been already demonstrated previously with gemcitabine.

Anonymous Patient Answer

What is the survival rate for locally advanced rectal carcinoma?

The 5-year overall survival rate is 49% +/- 21% for Stage III [rectal cancer](https://www.withpower.com/clinical-trials/rectal-cancer)s. The 5-year disease-specific survival rate is 55% +/- 18% for Stage III cancers. The 5-year disease-specific survival and overall survival in Stage III rectal cancers are markedly worse compared with Stage II and Stage I cancers and are similar to the 5-year disease-specific and overall survival rates reported for locally advanced rectal cancers in the current literature. This may reflect a high risk of distant spread, which may lead to early metastasis in rectal cancer.

Anonymous Patient Answer
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