Recruiting PHASE3 Locally Advanced Rectal Carcinoma

New treatment option for Locally Advanced Rectal Carcinoma

Official title Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer

ClinicalTrials.gov ID: NCT07372300

What this study is testing

What it's testing
The goal of this clinical trial is to investigate if the addition of modulated electro-hyperthermia (mEHT) improves tumor down-staging and pathological response in adult patients (20 years and above) with locally advanced rectal adenocarcinoma (cT3N0M0 with high risk of recurrence, cT3N1-2M0, or cT4N0-2M0). The main questions it aims to answer are: Does the addition of mEHT to the Total Neoadjuvant Therapy (TNT) regimen significantly increase the rate of tumor down-staging (ypT and ypN) compared to TNT alone?
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 20 and older

You may be able to join if

  • Age: 20 years and above
  • Gender: Not restricted
  • Initial pathological diagnosis of adenocarcinoma of the rectum
  • Expected survival ≥ six months
  • Clinical staging of cT3N0 with high recurrence risk or cT3N1-2 or cT4N0-2 rectal cancer, requiring neoadjuvant therapy, without distant metastasis...

You likely can't join if

  • (e) Active infection or severe underlying disease making the patient unsuitable for the trial treatments
  • Known HIV infection
  • Untreated thyroid disease
  • Active Crohn's disease or ulcerative colitis
  • Other systemic autoimmune diseases 9. History of any physical or mental disorder resulting the patient unable to understand or comply with trial...
See the full eligibility criteria
Who can join
  • Age: 20 years and above
  • Gender: Not restricted
  • Initial pathological diagnosis of adenocarcinoma of the rectum
  • Expected survival ≥ six months
  • Clinical staging of cT3N0 with high recurrence risk or cT3N1-2 or cT4N0-2 rectal cancer, requiring neoadjuvant therapy, without distant metastasis; must meet the following tumor definitions [staging system according to...
  • cT3: Tumor invades through the muscularis propria into pericolorectal tissues
  • cT4a: Tumor invades through the visceral peritoneum (including gross perforation of the bowel through tumor and continuous invasion of tumor through areas of inflammation to the surface of the visceral peritoneum)
  • cT4b: Tumor directly invades or adheres to adjacent organs or structures \ High recurrence risk factors: cT3 tumor ≤ 5 cm from the anal verge or MRI showing circumferential resection margin (CRM) \< 0.2 cm; cT4 tumor or...
What rules you out
  • (e) Active infection or severe underlying disease making the patient unsuitable for the trial treatments
  • Known HIV infection
  • Untreated thyroid disease
  • Active Crohn's disease or ulcerative colitis
  • Other systemic autoimmune diseases 9. History of any physical or mental disorder resulting the patient unable to understand or comply with trial requirements, or diminished social communication ability, or unable to...

The study team makes the final eligibility decision.

Where it's taking place

  • Chiayi City, Dalin Township, Taiwan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chiayi City, Dalin Township, Taiwan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.