BridgeMD
New treatment option for Stage II Rectal Cancer
Official title Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery
ClinicalTrials.gov ID: NCT03051464
What this study is testing
- What it's testing
- A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).
- 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 18 to 80
You may be able to join if
- Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound
- Rectal cancer staged as N0-1 by MRI or EUS/TRUS
- No metastatic lesion
- Rectal tumor occupying less than half of the circumference
- Tumor less than 5 cm on its largest dimension
You likely can't join if
- Patients with previous pelvic radiation
- Evidence of distant metastasis
- Extension of malignant disease to the anal canal
- Tumors staged as T4
- Tumors larger than 5 cm in length
See the full eligibility criteria
- Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound
- Rectal cancer staged as N0-1 by MRI or EUS/TRUS
- No metastatic lesion
- Rectal tumor occupying less than half of the circumference
- Tumor less than 5 cm on its largest dimension
- Tumor located at less than 10 cm from the anal verge
- Tumor penetration less than 5 mm in the mesorectal fat
- Tumor accessible for brachytherapy
- Lumen accessible for colonoscopy
- Patient should be a suitable candidate for brachytherapy and chemotherapy
- Older than 18 years of age
- Adequate birth control measures in women of childbearing potential
- Written informed consent
- Patients with previous pelvic radiation
- Evidence of distant metastasis
- Extension of malignant disease to the anal canal
- Tumors staged as T4
- Tumors larger than 5 cm in length
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States; Montreal, Quebec, Canada; Québec, Quebec, Canada. 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.