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Anti-metabolites

Combination Chemotherapy + Radiation for Rectal Cancer

Phase 1

Recruiting

Led By Ann Raldow

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2

Histologically confirmed rectal adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing how well radiation therapy and chemotherapy work together to treat rectal cancer.

Who is the study for?

This trial is for adults with stage II-III rectal adenocarcinoma confirmed by lab tests, without metastatic disease. They should be in good enough health to perform daily activities (KPS >= 70 or ECOG 0-2) and have normal blood counts and liver function tests. Pregnant or breastfeeding individuals, those with other active cancers, prior radiation in the same area, or conditions preventing MRI are excluded.Check my eligibility

What is being tested?

The study is testing if a short course of high-energy x-ray radiation followed by chemotherapy drugs like leucovorin, fluorouracil, oxaliplatin, and capecitabine can shrink tumors in rectal cancer patients without immediate surgery. The goal is to see if this approach improves quality of life by delaying or avoiding surgery.See study design

What are the potential side effects?

Possible side effects include skin irritation from radiation; nausea, vomiting, diarrhea from chemotherapy; increased risk of infection due to low blood cell counts; fatigue; and potential liver enzyme elevation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself and am up more than 50% of my waking hours.

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My cancer is a type of rectal cancer confirmed by tissue analysis.

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My cancer can be surgically removed.

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My cancer has not spread to other parts of my body.

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My cancer is at stage II or III according to MRI results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete clinical response rate

Secondary outcome measures

Anorectal function

Health-related quality of life

Incidence of adverse events

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (IMRT, mFOLFOX6, CapeOX, TME)Experimental Treatment8 Interventions

Patients undergo SCRT in the form of IMRT over 5 fractions daily for 5 consecutive days. Beginning 11-18 days after the last day of radiation therapy, patients receive either oxaliplatin IV and leucovorin IV on day 1 and fluorouracil IV on days 1-3 (mFOLFOX6) or oxaliplatin IV on day 1 and capecitabine PO BID on days 1-14 (CapeOX). Treatment with mFOLFOX6 repeats every 2 weeks for up to 8 cycles, and treatment with CapeOX repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. At 8-12 weeks after completion of all therapy, patients with residual tumor undergo TME. Patients with cCR undergo NOM.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surveillance

2010

Completed Phase 3

~2330

Total Mesorectal Excision

2016

Completed Phase 3

~250

Capecitabine

2013

Completed Phase 3

~3420

Fluorouracil

2014

Completed Phase 3

~11540

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Leucovorin

2005

Completed Phase 4

~5730

Oxaliplatin

2011

Completed Phase 4

~2560

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Joseph Drown FoundationUNKNOWN

Jonsson Comprehensive Cancer CenterLead Sponsor

360 Previous Clinical Trials

27,687 Total Patients Enrolled

Natera, Inc.Industry Sponsor

47 Previous Clinical Trials

42,342 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04703101 — Phase 1

Rectal Cancer Research Study Groups: Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Rectal Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04703101 — Phase 1

Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04703101 — Phase 1

Frequently Asked Questions

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

In which conditions is Intensity-Modulated Radiation Therapy usually applied?

"Intensity-Modulated Radiation Therapy is customarily employed in rectal carcinoma treatment, but can also be utilized to treat metastatic colorectal carcinoma, pancreatic endocrine carcinoma, and advanced esophageal cancers."

Answered by AI

What potential risks can be associated with Intensity-Modulated Radiation Therapy?

"As this is an early-stage Phase 1 trial, our team at Power assigned Intensity-Modulated Radiation Therapy a score of 1 on the safety scale—lowest because there is limited evidence for its efficacy and safety."

Answered by AI

What is the scope of participants in this investigation?

"Affirmative. Per the information available on clinicaltrials.gov, this medical study is actively recruiting participants with its initial post date of February 11th 2021 and latest update occurring on January 13th 2022. The trial requires 25 patients from 1 site to complete enrollment."

Answered by AI

Has Intensity-Modulated Radiation Therapy undergone any other clinical testing prior to this?

"Currently, 726 trials are taking place to investigate the efficacy of Intensity-Modulated Radiation Therapy. Of these studies, 249 have reached Phase 3. In regards to location, while the majority of clinical research is being conducted in Guangzhou, Guangdong province, 29794 sites worldwide are running IMRT based experiments."

Answered by AI

Are there any opportunities to join this experiment at present?

"Affirmative. The clinical trials website lists that this experiment is recruiting as of now - it was initially posted on February 11th 2021 and updated most recently on January 13rd 2022. 25 individuals are needed for the study at one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer

2021. "Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04703101.

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