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New treatment option for Rectal Cancer
Official title Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy
ClinicalTrials.gov ID: NCT02649647
What this study is testing
- What it's testing
- Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of bowel dysfunction after sphincter-preserving surgery, for which patients suffer from incontinence, urgency, and unpredictability defecation problems.
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 75
You may be able to join if
- Age: 18-75 years old
- ECOG performance status: 0-2
- Histologically confirmed adenocarcinoma of the rectum
- Distal border of the tumor located ≤ 12 cm from the anal verge
- Primary stage T3-4 or any node-positive disease
You likely can't join if
- Prior or concurrent malignancies within the past 5 years except for effectively treated squamous cell or basal cell skin cancer, melanoma in situ, or...
- Synchronous colon cancer
- History of colorectal resection except appendectomy
- Acute intestinal obstruction or perforation
- Multiple visceral resection
- Abdominoperineal resection
See the full eligibility criteria
- Age: 18-75 years old
- ECOG performance status: 0-2
- Histologically confirmed adenocarcinoma of the rectum
- Distal border of the tumor located ≤ 12 cm from the anal verge
- Primary stage T3-4 or any node-positive disease
- Undergoing long-course 5-fluorouracil based neoadjuvant chemoradiotherapy
- Conventional fractionated radiotherapy of at least 45 Gy
- Resectable disease after neoadjuvant chemoradiotherapy
- No evidence of distant metastasis
- Amenable to sphincter-preserving surgery
- Tolerable to general anesthesia
- Provision of written informed consent
- Prior or concurrent malignancies within the past 5 years except for effectively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
- Synchronous colon cancer
- History of colorectal resection except appendectomy
- Acute intestinal obstruction or perforation
- Multiple visceral resection
- Abdominoperineal resection
- American Society of Anesthesiologists (ASA) class Ⅳ or Ⅴ
- Pregnant or nursing, fertile patients do not use effective contraception
- Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
- Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. 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.