Colorectal CancerPhase 2NCT03725254
CRT Versus Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of CRC
A Phase 2 study testing lymphadenectomy and chemoradiotherapy in people with Colorectal Cancer and Retroperitoneal Lymph Node Metastasis, run by Fudan University at 1 site in China.
Trial summary
The study aims to compare the effects of chemoradiation versus radical surgery in treating retro-peritoneal or para-aortic lymph node metastasis in colorectal cancer. By prolonging patients' progression-free survival, local control rate and overall survival, investigators can conclude the best regimen for colorectal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Retroperitoneal Lymph Node Metastasis, Para-aortic Lymph Node Metastasis
- What is being tested?
- lymphadenectomy and chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2018to 1 Oct 2024
- Phase
- Phase 2
- 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
- A medical history of colorectal cancer
- Pathological or clinical diagnosis of retroperitoneal/para-vascular lymph node metastases, and located below the level of renal veins.
- The treatment target is no evidence of disease (NED), including 3 cohorts:
- Initial treatment (primary lesion + retroperitoneal LN oligometastasis); B. Postoperative retroperitoneal/paravascular LN oligometastase; C. Postoperative retroperitoneal/paravascular LN metastasis with other organ metastases (up to NED)
- ECOG PS 0-2
- Ability to follow the program during the study period
- Signing written informed consent
Who cannot join
- Retroperitoneal LN metastasis is above the level of the renal vein.
- Unable to reach NED.
- Previous pelvic radiotherapy, the field of irradiation overlaps with this time.
- Pregnancy or breastfeeding women.
- Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
- If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
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- Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months
- Organ transplantation requires immunosuppressive therapy
- Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- Subjects Blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets ≥ 100 × 109 / L; ALT, AST≤2.5 times normal upper limit; ALP≤2.5 times normal upper limit; serum total bilirubin <1.5 times normal upper limit; serum creatinine <1 times normal upper limit; serum albumin ≥30g/L
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Ji Zhu, MD
About this study
Official title: Curative Chemoradiotherapy Versus Radical Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of Colorectal Cancer
The study aims to compare the effects of chemoradiation versus radical surgery in treating retro-peritoneal or para-aortic lymph node metastasis in colorectal cancer. By prolonging patients' progression-free survival, local control rate and overall survival, investigators can conclude the best regimen for colorectal cancer patients.
- Conditions
- Colorectal Cancer, Retroperitoneal Lymph Node Metastasis, Para-aortic Lymph Node Metastasis
- Being tested
- lymphadenectomy, chemoradiotherapy
- Keywords
- Chemoradiotherapy, retroperitoneal lymphadenectomy, IMRT, SBRT
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphadenectomyProcedure or surgery
The retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space.
chemoradiotherapyRadiation
Radiation therapy is highly appropriate, based on the characteristics of the lesion and the surrounding critical organs, and select IMRT or stereotactic radiotherapy (SBRT).
| Study group | Role | What they receive |
|---|---|---|
| radical surgery | Active comparator | In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery. Receives: Procedure: lymphadenectomy |
| radical chemoradiotherapy | Experimental | In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy. Receives: Radiation: chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Also called PFS.
Measured: From date of randomization until the date of disease progressed for any reason, assessed up to 5 years
Secondary outcomes (2)
overall survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. Also called OS.
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years
local control rate
no recurrence of the retroperitoneal or paraaortic lymph node region.
Measured: From date of randomization until the date of disease recurrece, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start20 Oct 2018
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Ji, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725254
- Sponsor's protocol ID
- FDRT-008
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curative Chemoradiotherapy Versus Radical Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03725254
- Acronym / sponsor ID
- FDRT-008
- Conditions
- Colorectal Cancer, Retroperitoneal Lymph Node Metastasis, Para-aortic Lymph Node Metastasis
- Keywords
- Chemoradiotherapy, retroperitoneal lymphadenectomy, IMRT, SBRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 31 Oct 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 study aims to compare the effects of chemoradiation versus radical surgery in treating retro-peritoneal or para-aortic lymph node metastasis in colorectal cancer. By prolonging patients' progression-free survival, local control rate and overall survival, investigators can conclude the best regimen for colorectal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radical surgery | Active comparator | Procedure: lymphadenectomyIn this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery. |
| radical chemoradiotherapy | Experimental | Radiation: chemoradiotherapyIn this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A medical history of colorectal cancer
- Pathological or clinical diagnosis of retroperitoneal/para-vascular lymph node metastases, and located below the level of renal veins.
- The treatment target is no evidence of disease (NED), including 3 cohorts:
- Initial treatment (primary lesion + retroperitoneal LN oligometastasis); B. Postoperative retroperitoneal/paravascular LN oligometastase; C. Postoperative retroperitoneal/paravascular LN metastasis with other organ metastases (up to NED)
- ECOG PS 0-2
Key exclusion criteria (10 listed)
- Retroperitoneal LN metastasis is above the level of the renal vein.
- Unable to reach NED.
- Previous pelvic radiotherapy, the field of irradiation overlaps with this time.
- Pregnancy or breastfeeding women.
- Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
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 |
|---|---|---|
| lymphadenectomyThe retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space. | Procedure or surgery | radical surgery |
| chemoradiotherapyRadiation therapy is highly appropriate, based on the characteristics of the lesion and the surrounding critical organs, and select IMRT or stereotactic radiotherapy (SBRT). | Radiation | radical chemoradiotherapy |
Primary outcome
Progression-free survival
Time frame: From date of randomization until the date of disease progressed for any reason, assessed up to 5 years
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Also called PFS.
2 secondary outcomes
overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
local control rate
Time frame: From date of randomization until the date of disease recurrece, assessed up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lymphadenectomy and chemoradiotherapy in people with Colorectal Cancer and Retroperitoneal Lymph Node Metastasis, run by Fudan 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 7 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: status not confirmed, as of the sponsor's last update on 23 Jan 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ji Zhu, MD (+86-2164175590 ext. 81607, leo.zhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of randomization until the date of disease progressed for any reason, assessed up to 5 years). 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 23 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.