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Chemotherapy

Radiation Therapy for Rectal Cancer

Phase 1

Waitlist Available

Led By Nageshwara V Dasari

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a new immunotherapy drug in combination with chemotherapy and radiation before surgery to see if it is effective in treating rectal cancer.

Eligible Conditions

Rectal Cancer

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

Incidence of dose limiting toxicities of TVEC

Pharmacotherapy

Secondary outcome measures

Disease free survival

Overall survival

Pathological complete response

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (T-VEC, capecitabine, chemoradiation)Experimental Treatment6 Interventions

Patients receive talimogene laherparepvec intralesionally via endoscopy on weeks 1, 4, 6, and 8. Patients receive 5-fluorouracil IV by bolus and over 46 hours, leucovorin IV bolus, and oxaliplatin IV over 2 hours on weeks 2 and 4. Patients also receive capecitabine orally PO BID followed by radiation therapy for 28 fractions on days 1-5 of weeks 8-13. Patients undergo resection surgery on weeks 21-25.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Capecitabine

2013

Completed Phase 3

~3420

Fluorouracil

2014

Completed Phase 3

~11540

Leucovorin

2005

Completed Phase 4

~5730

Oxaliplatin

2011

Completed Phase 4

~2560

Talimogene Laherparepvec

2008

Completed Phase 3

~640

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,680 Previous Clinical Trials

40,928,516 Total Patients Enrolled

Nageshwara V DasariPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO

2 Previous Clinical Trials

57 Total Patients Enrolled

Frequently Asked Questions

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

What effects is this clinical trial attempting to achieve?

"This study's primary objective, to be assessed in the four weeks after surgery, is to record any dose-limiting toxicities of TVEC. Secondary objectives include Disease Free Survival (reported with Kaplan-Meier method), Pathological Complete Response (with proportions and confidence intervals) and Overall Survival (also reported using Kaplan-Meier)."

Answered by AI

Could you please provide me with a rundown of past experiments related to Radiation Therapy?

"Presently, there are 747 medical trials being conducted to examine the efficacy of Radiation Therapy. Of those in progress, 249 have reached Phase 3 and encompass 30035 sites worldwide with a concentration in Guangzhou, Guangdong."

Answered by AI

Has Radiation Therapy achieved official sanction from the FDA?

"Due to the paucity of evidence surrounding radiation therapy's efficacy and safety, this treatment was assessed as a 1 on our scale."

Answered by AI

For which medical conditions is Radiation Therapy usually administered?

"Radiation Therapy is the usual treatment for rectal carcinoma, and has also been used to combat metastatic colorectal carcinoma, pancreatic endocrine carcinomas, and advanced esophageal cancers."

Answered by AI

What is the current participant count of this experiment?

"Unfortunately, this research trial is no longer accepting subjects. It was initially opened on September 20th 2017 and last revised October 18th 2022. If you are still in search of a clinical trial, there are currently 1049 trials recruiting for rectal carcinoma patients and 747 studies actively enrolling individuals that require Radiation Therapy."

Answered by AI

Are there opportunities for participation in this experiment still available?

"According to clinicaltrials.gov, this medical trial is not currently accepting patients. The initial posting was on September 20th 2017 and the latest update occurred October 18th 2022. While this research endeavour is inactive in terms of recruitment, there are 1,796 other trials actively looking for participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer

2017. "Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03300544.

All > Rectal Cancer