Rectal CancerPERNNCT02649647
Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy
A study testing Conventional resection and Proximally extended resection in people with Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Conventional resection and Proximally extended resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Qiyuan Qin, M.D., 86-20-38254052, qinqy3@mail.sysu.edu.cn
About this study
Official title: Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
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. Furthermore, preoperative chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal cancer surgery.
Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a major concern. When conventional surgical procedures would retain part of sigmoid colon that has been included in the radiation target, sphincter-preserving surgery with proximally extended resection margin could provide an intact proximal colon limb for the anastomosis.
It is not known yet whether proximally extended resection improves postoperative bowel function or anastomotic integrity for patients with rectal cancer after neoadjuvant chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and without proximally extended resection margin, to observe the postoperative bowel function, as well as the incidence of anastomotic complication. This study will examine a new surgical strategy, which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.
- Conditions
- Rectal Cancer
- Being tested
- Conventional resection, Proximally extended resection
- Keywords
- Rectal cancer, Neoadjuvant therapy, Chemoradiotherapy, Resection margin, Bowel function, Anastomosis
- Medical subject headings
- Rectal Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional resectionProcedure or surgery
The conventional technique requests an excision of at least 10 cm of bowel proximal to the tumor, and the sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.
Proximally extended resectionProcedure or surgery
The modified technique requests an excision of the whole sigmoid colon and rectum proximal to the tumor, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Resection | Active comparator | Patients receive conventional resection with standard proximal excision margin. The sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed. Receives: Procedure: Conventional resection |
| Proximally Extended Resection | Experimental | Patients receive proximally extended resection. The whole sigmoid colon and rectum proximal to the tumor is removed, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed. Receives: Procedure: Proximally extended resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major bowel dysfunction
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function. Number of participants with major LARS will be calculated for the incidence of major bowel dysfunction.
Measured: at the time of 12 months after the restoration of defunctioning stoma
Secondary outcomes (13)
Incidence of anastomotic leakage
Measured: up to 6 months postoperatively
Incidence of anastomotic stenosis
Measured: 12 months postoperatively
Incidence of major bowel dysfunction
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.
Measured: at the time of 36 months after the restoration of defunctioning stoma
Incidence of major bowel dysfunction
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.
Measured: at the time of 60 months after the restoration of defunctioning stoma
3-year disease free survival
Measured: 3 years
5-year overall survival
Measured: 5 years
Incidence of anastomotic haemorrhage
Measured: up to 1 month postoperatively
Incidence of intraoperative complication
Measured: at the time of surgery
Postoperative morbidity
Measured: up to 30 days postoperatively
Postoperative mortality
Measured: up to 30 days postoperatively
Quality of life impairment
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Measured: at the time of 12 months after the restoration of defunctioning stoma
Quality of life impairment
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Measured: at the time of 36 months after the restoration of defunctioning stoma
Quality of life impairment
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Measured: at the time of 60 months after the restoration of defunctioning stoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Wang, MD, PhD, Study director, Sixth Affiliated Hospital, Sun Yat-sen UniversityHui Wang, M.D., Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649647
- Sponsor's protocol ID
- PERN2015019
- Acronym
- PERN
- Status last verified
- Nov 2023
- First submitted
- 5 Jan 2016
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02649647
- Acronym / sponsor ID
- PERN / PERN2015019
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Neoadjuvant therapy, Chemoradiotherapy, Resection margin, Bowel function, Anastomosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shanghai Changzheng Hospital, Peking Union Medical College Hospital
- Study start
- Feb 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Furthermore, preoperative chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal cancer surgery.
Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a major concern. When conventional surgical procedures would retain part of sigmoid colon that has been included in the radiation target, sphincter-preserving surgery with proximally extended resection margin could provide an intact proximal colon limb for the anastomosis.
It is not known yet whether proximally extended resection improves postoperative bowel function or anastomotic integrity for patients with rectal cancer after neoadjuvant chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and without proximally extended resection margin, to observe the postoperative bowel function, as well as the incidence of anastomotic complication. This study will examine a new surgical strategy, which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Resection | Active comparator | Procedure: Conventional resectionPatients receive conventional resection with standard proximal excision margin. The sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed. |
| Proximally Extended Resection | Experimental | Procedure: Proximally extended resectionPatients receive proximally extended resection. The whole sigmoid colon and rectum proximal to the tumor is removed, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional resectionThe conventional technique requests an excision of at least 10 cm of bowel proximal to the tumor, and the sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed. | Procedure or surgery | Conventional Resection |
| Proximally extended resectionThe modified technique requests an excision of the whole sigmoid colon and rectum proximal to the tumor, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed. | Procedure or surgery | Proximally Extended Resection |
Primary outcome
Incidence of major bowel dysfunction
Time frame: at the time of 12 months after the restoration of defunctioning stoma
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function. Number of participants with major LARS will be calculated for the incidence of major bowel dysfunction.
13 secondary outcomes
Incidence of anastomotic leakage
Time frame: up to 6 months postoperatively
Incidence of anastomotic stenosis
Time frame: 12 months postoperatively
Incidence of major bowel dysfunction
Time frame: at the time of 36 months after the restoration of defunctioning stoma
Incidence of major bowel dysfunction
Time frame: at the time of 60 months after the restoration of defunctioning stoma
3-year disease free survival
Time frame: 3 years
5-year overall survival
Time frame: 5 years
Incidence of anastomotic haemorrhage
Time frame: up to 1 month postoperatively
Incidence of intraoperative complication
Time frame: at the time of surgery
Postoperative morbidity
Time frame: up to 30 days postoperatively
Postoperative mortality
Time frame: up to 30 days postoperatively
Quality of life impairment
Time frame: at the time of 12 months after the restoration of defunctioning stoma
Quality of life impairment
Time frame: at the time of 36 months after the restoration of defunctioning stoma
Quality of life impairment
Time frame: at the time of 60 months after the restoration of defunctioning stoma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Wang, MD, PhD study director
Sixth Affiliated Hospital, Sun Yat-sen University
Hui Wang, M.D. principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional resection and Proximally extended resection in people with Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiyuan Qin, M.D. (86-20-38254052, qinqy3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major bowel dysfunction (time frame: at the time of 12 months after the restoration of defunctioning stoma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.