Colon NeoplasmNCT05279612
Effect Analysis of Neoadjuvant Chemoradiotherapy Combined With Surgery in Laparoscope for Advanced Colon Cancer
An observational study of Colon Neoplasm, run by Tang-Du Hospital at 1 site in China.
Trial summary
In this study, a randomized controlled trial was conducted on advanced colon cancer patients with preoperative tumor staging T1-4/N1-2/M0 or T4/N0/M0 to determine the effectiveness of preoperative short-term radiotherapy combined with chemotherapy and whether it can effectively reduce the postoperative local… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Neoplasm
- What is being tested?
- Short-term neoadjuvant chemoradiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 May 2025
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of colon neoplasm, 18 years to 70 years, Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2, thoraco-abdomina CT showed no obvious metastasis（The CT of liver and lung show uncertainty tubercle,suggestive performed PET-CT), cT4,cN0-2,M0 radiography Inclusion Criteria（according postoperative enhanced CT or MRI）
Who may be able to join
- Diagnosis of colon neoplasm
- 18 years to 70 years
- Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2
- ECOGS score≤2
- thoraco-abdomina CT showed no obvious metastasis（The CT of liver and lung show uncertainty tubercle,suggestive performed PET-CT) cT4,cN0-2,M0 radiography Inclusion Criteria（according postoperative enhanced CT or MRI）
- progress tubercle penetrate peritoneotome base
- progress tubercle penetrate serous surface of neighboring organ
- progress tubercle development by late mesentery or side abdominis
Who cannot join
- Appeared other system cancer
- Patient with postoperative recurrent of colon cancer
- Patient with malignancies history in recent 5 years
- Pregnant or female of suckle period
- The patient have adjuvant radiotherapy record in other system cancer before this time treatment，and Patient with surgical contraindications.
- The patient have accepted adjuvant chemoradiotherapy before this time treatment.
Show all 9Show fewer
- Distant metastasis found during surgery
- Patients with poor radiotherapy compliance and difficulty in coordination
- Patients with mental disorders
Trial locations and contacts
1 site in 1 country.
China1 site
General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University
Xi’an, Shanxi
About this study
Official title: Effect Analysis of Neoadjuvant Chemoradiotherapy Combined With Radical Surgery ( CME + D3 ) for Advanced Colon Cancer : Prospective, a Single-arm, Single Central, Clinical Trial Research
In this study, a randomized controlled trial was conducted on advanced colon cancer patients with preoperative tumor staging T1-4/N1-2/M0 or T4/N0/M0 to determine the effectiveness of preoperative short-term radiotherapy combined with chemotherapy and whether it can effectively reduce the postoperative local recurrence rate, so as to provide better treatment for colon cancer patients and improve the oncological treatment effect of colon cancer.
Read the detailed description
This is prospective,a single-arm, single center, clinical trail study.The patient entered the study after meeting that criteria.The ORR, R0 resection, OS and DFS of patients and neoplasm down-staging status,etc would be compared.
- Conditions
- Colon Neoplasm
- Being tested
- Short-term neoadjuvant chemoradiotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term neoadjuvant chemoradiotherapyRadiation
Short-term radiotherapy ( 25 Gy, 5f ) + XELOX regimen was performed before operation for two cycles. After the condition was evaluated by enhanced CT, whether the patients belonged to PD, SD, PR and CR was analyzed (reference RECIST 1.1). Surgery was performed four weeks after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemoradiotherapy group | preoperative 1 circle chemotherapy(CapeOX) combined with short-course radiotherapy ，Surgical treatment(CME+D3) after four weeks of 2 circle chemotherapy(CapeOX). Receives: Radiation: Short-term neoadjuvant chemoradiotherapy | |
| neadjuvant chemotherapy group | preoperative 3 circle chemotherapy(CapeOX) combined with surgical treatment(CME+D3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate patients ORR
Investigate patients ORR(objective response rate ) include CR(complete response) and PR(partial response)
Measured: 7 days after surgery
Secondary outcomes (6)
neoplasm down-staging status
Observation of neoplasm down-staging status in patients according to RECIST 1.1
Measured: one month after surgery
Investigate operation safety score
Operation safety reference Clavien degree of postoperative complication
Measured: one month after surgery
local recurrent rate of neoplasm
Observation local recurrent rate of neoplasm in patients
Measured: 2 years after surgery
Quality of life score
Investigate postoperative Quality of life in patients after surgery
Measured: one month after surgery
Investigate patience pRR (pathologic response rate)
According to the English version of the Japanese Gastric Cancer Classification (JCGC) 3rd edition, pRR is defined as survival of tumor cells remaining in less than 2/3 of the tumor area (level Ib or higher)
Measured: 7 days after surgery
R0 resection
R0 resection indicates a microscopically margin-negative resection,in which no gross or microscopic tumor remains in the primary tumor bed
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Oct 2021
- Primary completion30 Oct 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon NeoplasmStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nan Wang, Doctor, Study director, General Surgery,Tang-Du of Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279612
- Sponsor's protocol ID
- K202012-12
- Status last verified
- Nov 2022
- First submitted
- 6 Feb 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Analysis of Neoadjuvant Chemoradiotherapy Combined With Radical Surgery ( CME + D3 ) for Advanced Colon Cancer : Prospective, a Single-arm, Single Central, Clinical Trial Research
- ClinicalTrials.gov ID
- NCT05279612
- Acronym / sponsor ID
- K202012-12
- Conditions
- Colon Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 15 Mar 2022 (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.
In this study, a randomized controlled trial was conducted on advanced colon cancer patients with preoperative tumor staging T1-4/N1-2/M0 or T4/N0/M0 to determine the effectiveness of preoperative short-term radiotherapy combined with chemotherapy and whether it can effectively reduce the postoperative local recurrence rate, so as to provide better treatment for colon cancer patients and improve the oncological treatment effect of colon cancer.
Detailed description
This is prospective,a single-arm, single center, clinical trail study.The patient entered the study after meeting that criteria.The ORR, R0 resection, OS and DFS of patients and neoplasm down-staging status,etc would be compared.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemoradiotherapy group | – | Radiation: Short-term neoadjuvant chemoradiotherapypreoperative 1 circle chemotherapy(CapeOX) combined with short-course radiotherapy ，Surgical treatment(CME+D3) after four weeks of 2 circle chemotherapy(CapeOX). |
| neadjuvant chemotherapy group | – | –preoperative 3 circle chemotherapy(CapeOX) combined with surgical treatment(CME+D3) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of colon neoplasm, 18 years to 70 years, Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2, thoraco-abdomina CT showed no obvious metastasis（The CT of liver and lung show uncertainty tubercle,suggestive performed PET-CT), cT4,cN0-2,M0 radiography Inclusion Criteria（according postoperative enhanced CT or MRI）
Key inclusion criteria (8 listed)
- Diagnosis of colon neoplasm
- 18 years to 70 years
- Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2
- ECOGS score≤2
- thoraco-abdomina CT showed no obvious metastasis（The CT of liver and lung show uncertainty tubercle,suggestive performed PET-CT) cT4,cN0-2,M0 radiography Inclusion Criteria（according postoperative enhanced CT or MRI）
Key exclusion criteria (9 listed)
- Appeared other system cancer
- Patient with postoperative recurrent of colon cancer
- Patient with malignancies history in recent 5 years
- Pregnant or female of suckle period
- The patient have adjuvant radiotherapy record in other system cancer before this time treatment，and Patient with surgical contraindications.
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 |
|---|---|---|
| Short-term neoadjuvant chemoradiotherapyShort-term radiotherapy ( 25 Gy, 5f ) + XELOX regimen was performed before operation for two cycles. After the condition was evaluated by enhanced CT, whether the patients belonged to PD, SD, PR and CR was analyzed (reference RECIST 1.1). Surgery was performed four weeks after chemotherapy. | Radiation | neoadjuvant chemoradiotherapy group |
Primary outcome
Investigate patients ORR
Time frame: 7 days after surgery
Investigate patients ORR(objective response rate ) include CR(complete response) and PR(partial response)
6 secondary outcomes
neoplasm down-staging status
Time frame: one month after surgery
Investigate operation safety score
Time frame: one month after surgery
local recurrent rate of neoplasm
Time frame: 2 years after surgery
Quality of life score
Time frame: one month after surgery
Investigate patience pRR (pathologic response rate)
Time frame: 7 days after surgery
R0 resection
Time frame: immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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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. This study is not recruiting at the moment.
Nan Wang, Doctor study director
General Surgery,Tang-Du of Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Neoplasm, run by Tang-Du Hospital 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 8 inclusion and 9 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 14 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate patients ORR (time frame: 7 days after surgery). 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 14 Nov 2022.