Stage II Rectal Cancer study: Chemoradiation + EBRT Boost vs Chemoradiation + HDRBT Boost
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
- This study aims to find out which of two radiation boost techniques is better for treating rectal cancer without needing surgery.
- Who it's for
- People with stage II or III rectal cancer that has not spread to distant parts of the body.
- What's involved
- Participants will receive standard chemotherapy and radiation, followed by either an external radiation boost or an internal radiation boost (brachytherapy).
- Time commitment
- The study involves a course of radiation and chemotherapy, with specific follow-up visits to monitor the treatment's effect.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Dallas, Texas, United States; Montreal, Quebec, Canada; Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.