Almost-cCRPhase 3NCT03431428
Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients
A Phase 3 study testing transanal surgery, Miles surgery and Preoperative chemoradiotherapy in people with Almost-cCR and Surgery, run by Zhang Rui at 1 site in China.
Trial summary
The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Almost-cCR, Surgery, Rectal Cancer
- What is being tested?
- transanal surgery, Miles surgery and Preoperative chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 477 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Histology is confirmed as rectal adenocarcinoma.
- 18 to 75 years old.
- Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）.
- The anus couldn't be retained after TME.
- Almost-cCR or cCR recurrence during observation.
Who cannot join
- Patients were unable to tolerate the operation.
- Preoperative stage: T4b or progress during the treatment.
- HIV infection stage or chronic hepatitis B.
- Active clinical severe infections.
- Evil liquid state or decompensation of organ function.
- Other malignant tumor history in five years.
- Other primary carcinoma.
- Unstable condition and incompliance of the patient
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liaoning cancer Hospital
Shenyang, Liaoning
Rui Zhang, doctor, 13898872185, zzzrrr1234@sina.com
About this study
Official title: Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients: A Case-matched Study
The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.
Read the detailed description
Patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of XELOX at the interval. All almost-cCRs after neoadjuvant treatment were randomly divided into minimal operation group or Mile's group. All cCRs were treated with "watch and wait". Patients after local recurrence were randomly divided into minimal operation group or Mile's group. If pathological result was pathological staging 3 after neoadjuvant therapy（ypT3） in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (APR). With 3 years follow-up，the main research goals are 3 years of progression-free survival(PFS) and overall survival(OS). Secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.
- Conditions
- Almost-cCR, Surgery, Rectal Cancer
- Being tested
- transanal surgery, Miles surgery, Preoperative chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transanal surgeryProcedure or surgery
Transanal surgery could Preserve anus to reduce trauma and improve the quality of life
Miles surgeryProcedure or surgery
Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.
Preoperative chemoradiotherapyDrug
After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.
| Study group | Role | What they receive |
|---|---|---|
| transanal surgery | Experimental | To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm.
The intestinal wall was sutured to ensure the integrity of the bowel. Receives: Procedure: transanal surgery; Drug: Preoperative chemoradiotherapy |
| Miles surgery | Placebo comparator | According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed. Receives: Procedure: Miles surgery; Drug: Preoperative chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The progression-free survival of 3 years
Measured: three years
OS
3 years of overall survival time
Measured: three years
Secondary outcomes (7)
carcinoembryonic antigen（CEA）
The level of carcinoembryonic antigen in blood
Measured: every 3 months,for 2 years
carbohydrate antigen 19-9（CA-199）
The level of carbohydrate antigen 19-9 in blood
Measured: every 3 months,for 2 years
International Index of Erectile Function-15
Describe the function of Erectile ,only for male patients
Measured: every 3 months ,for 2 years
International prostate symptom score
Describe the function of prostate,only for male patients
Measured: every 3 months ,for 2 years
Female sexual function index
Describe the function of sexual for female patients
Measured: every 3 months,for 2 years
Wexner incontinence score
Describe the degree of Anus incontinence
Measured: every 3 months,for 2 years
QOL
Describe the quality of life for tumor patients
Measured: every 3 months,for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Almost-cCRStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 477 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang Rui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Rui, Liaoning Cancer Hospital & Institute
- Investigators
- peirong ding, doctor, Principal investigator, Sun Yat-Sen University Cancer Centerji zhu, doctor, Principal investigator, Fudan Universityzhenning wang, doctor, Principal investigator, First Hospital of China Medical Universityhong zhang, doctor, Principal investigator, Shengjing Hospitalyu han, doctor, Principal investigator, The Second Affiliated Hospital of Harbin Medical Universityzhaocheng chi, doctor, Principal investigator, Jilin Provincial Tumor Hospitalquan wang, doctor, Principal investigator, The First Bethune Hospital of Jilin Universityge liu, doctor, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431428
- Sponsor's protocol ID
- 20171112
- Status last verified
- Dec 2017
- First submitted
- 13 Jan 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Motamedi MAK, Mak NT, Brown CJ, Raval MJ, Karimuddin AA, Giustini D, Phang PT. Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy. Cochrane Database Syst Rev. 2023 Jun 13;6(6):CD002198. doi: 10.1002/14651858.CD002198.pub3.
PubMed 37310167
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients: A Case-matched Study
- ClinicalTrials.gov ID
- NCT03431428
- Acronym / sponsor ID
- 20171112
- Conditions
- Almost-cCR, Surgery, Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 477 participants (estimated)
- Lead sponsor
- Zhang RuiUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Feb 2018 (actual)
- 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.
The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.
Detailed description
Patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of XELOX at the interval. All almost-cCRs after neoadjuvant treatment were randomly divided into minimal operation group or Mile's group. All cCRs were treated with "watch and wait". Patients after local recurrence were randomly divided into minimal operation group or Mile's group. If pathological result was pathological staging 3 after neoadjuvant therapy（ypT3） in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (APR). With 3 years follow-up，the main research goals are 3 years of progression-free survival(PFS) and overall survival(OS). Secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transanal surgery | Experimental | Procedure: transanal surgery, Drug: Preoperative chemoradiotherapyTo ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm. The intestinal wall was sutured to ensure the integrity of the bowel. |
| Miles surgery | Placebo comparator | Procedure: Miles surgery, Drug: Preoperative chemoradiotherapyAccording to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histology is confirmed as rectal adenocarcinoma.
- 18 to 75 years old.
- Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）.
- The anus couldn't be retained after TME.
- Almost-cCR or cCR recurrence during observation.
Key exclusion criteria (8 listed)
- Patients were unable to tolerate the operation.
- Preoperative stage: T4b or progress during the treatment.
- HIV infection stage or chronic hepatitis B.
- Active clinical severe infections.
- Evil liquid state or decompensation of organ function.
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 |
|---|---|---|
| transanal surgeryTransanal surgery could Preserve anus to reduce trauma and improve the quality of life | Procedure or surgery | transanal surgery |
| Miles surgeryMiles surgery cut off the anus, enlarge the trauma and reduce the quality of life. | Procedure or surgery | Miles surgery |
| Preoperative chemoradiotherapyAfter preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation. | Drug | Miles surgery, transanal surgery |
Primary outcome
PFS
Time frame: three years
The progression-free survival of 3 years
OS
Time frame: three years
3 years of overall survival time
7 secondary outcomes
carcinoembryonic antigen（CEA）
Time frame: every 3 months,for 2 years
carbohydrate antigen 19-9（CA-199）
Time frame: every 3 months,for 2 years
International Index of Erectile Function-15
Time frame: every 3 months ,for 2 years
International prostate symptom score
Time frame: every 3 months ,for 2 years
Female sexual function index
Time frame: every 3 months,for 2 years
Wexner incontinence score
Time frame: every 3 months,for 2 years
QOL
Time frame: every 3 months,for 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Derived from this study: PubMed 37310167Motamedi MAK, Mak NT, Brown CJ, Raval MJ, Karimuddin AA, Giustini D, Phang PT. Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy. Cochrane Database Syst Rev. 2023 Jun 13;6(6):CD002198. doi: 10.1002/14651858.CD002198.pub3.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
peirong ding, doctor principal investigator
Sun Yat-Sen University Cancer Center
ji zhu, doctor principal investigator
Fudan University
zhenning wang, doctor principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transanal surgery, Miles surgery and Preoperative chemoradiotherapy in people with Almost-cCR and Surgery, run by Zhang Rui 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Feb 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rui zhang, doctor (8613898872185, zzzrrr1234@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431428, which also lists 1 linked publication.
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 13 Feb 2018.