Rectal CancerPCARNCT03601156
Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer
A study testing intraarterial chemoembolization and intravenous chemotherapy in people with Rectal Cancer, run by Third Military Medical University at 3 sites in China.
Trial summary
Compared to postoperative chemotherapy combined with radiotherapy, preoperative chemotherapy combined with radiotherapy shows higher sphincter preservation rate and lower local recurrence rate in locally advanced rectal cancer. 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?
- intraarterial chemoembolization and intravenous chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2014to Nov 2020
- Phase
- Interventional
- 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
- Histologic or cytologic diagnosis of rectal cancer, Stage IV.
- Males or females between 18 Years to 75 Years.
- No prior cisplatin-based chemotherapy or radiotherapy.
- Performance status of 0～2 on the ECOG criteria.
- Adequate hematologic (Leukocyte count >= 4,000/uL, neutrophil count >= 1,500/uL, hemoglobin >= 10 g/dL, platelets >= 100,000/uL), hepatic (AST \& ALT =< upper normal limit(UNL)x1.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL x1.5 or creatinine clearance rate ≥60 ml/min) function.
- Patient can take oral medicine
- Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
Who cannot join
- Patient with allergic to S-1 or ingredient of Oxaliplatin
- Patient with Peripheral neuropathy
- Diagnosed fibrosis of lung;pulmonary fibrosis or interstitial pneumonia within 28 days.
- Medically uncontrolled serious heart, renal failure, liver failure, hemorrhagic peptic ulcer, paralysis of intestine , ileus, poor controlled diabetes.
- Enrollment in other study.
- Pregnant or breast-feeding.
- Seriously psyche or intelligence problem.
- Inability to comply with protocol or study procedures.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Dong Wang, PH.D., 86-23-68757151, dongwang64@hotmail.com
Dong Wang, PH.D.
- Recruiting
Chongqing Zhongshan Hospital
Chongqing, Chongqing Municipality
Zhixiang Yang, M.D., 86-13032372491
Zhixiang Yang, M.D.
- Recruiting
Jiangjin Central Hospital
Chongqing, Chongqing Municipality
Debing Xiang, M.D., 86-13320336639
Debing Xiang, M.D.
About this study
Official title: Multi-center Study of Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in the Management of Locally Advanced Rectal Cancer
Compared to postoperative chemotherapy combined with radiotherapy, preoperative chemotherapy combined with radiotherapy shows higher sphincter preservation rate and lower local recurrence rate in locally advanced rectal cancer. The purpose of this study is to evaluate the response and prognosis of intraarterial chemoembolization and intravenous infusion chemotherapy in patients with rectal T3-T4 and/or N+ rectal cancer before operation.
- Conditions
- Rectal Cancer
- Being tested
- intraarterial chemoembolization, intravenous chemotherapy
- Keywords
- rectal cancer, intraarterial chemoembolization, radiotherpy, Oxaliplatin, Tegafur Gimeracil and Oteracil Porassium Capsule
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraarterial chemoembolizationDevice
intravenous chemotherapyDevice
| Study group | Role | What they receive |
|---|---|---|
| NATACE-RT | Experimental | Patients receive Oxaliplatin 130mg/m2 intraarterial chemoembolization on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA < 1.25 mm2 receive 80 mg/day; 1.25 mm2 < BSA < 1.5mm2 recive 100 mg/day, BSA>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks) Receives: Device: intraarterial chemoembolization |
| NACT-RT | Active comparator | Patients receive Oxaliplatin 130mg/m2 intravenous chemotherapy on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA < 1.25 mm2 receive 80 mg/day; 1.25 mm2 < BSA < 1.5mm2 recive 100 mg/day, BSA>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks) Receives: Device: intravenous chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Pathological complete response (pCR) was determined on tumor resection specimens after completion of neoadjuvant therapy, and was defined as no evidence of residual invasive and ductal disease in the rectum and lymph nodes
Measured: pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy
Secondary outcomes (6)
the Sphincter Preservation Rate
Measured: 3 month
Disease-free survival
Measured: Following surgery, 5 years
Overall Survival
Measured: the first day of treatment to death or last survival confirm date; assesed up to 5 years
Down Staging Rate
Measured: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Number of Participants with Adverse Events
Measured: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Number of Postoperative Complication
Measured: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startJun 2014
- Primary completionDec 2018 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Wang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601156
- Sponsor's protocol ID
- PCAR
- Acronym
- PCAR
- Status last verified
- Jul 2018
- First submitted
- 23 Apr 2015
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qian C, Yang W, Li M, Feng Y, Dai N, Luo H, Jian D, Li X, Yang Y, He Y, Wang D, Li C, Xiao H. Negative prognostic impact of Co-mutations in TGFbeta and TP53 pathways in surgically resected rectal tumors following neoadjuvant chemoradiotherapy. Eur J Surg Oncol. 2024 Apr;50(4):108242. doi: 10.1016/j.ejso.2024.108242. Epub 2024 Mar 6.
PubMed 38460248Yang B, Shan J, Feng Y, Dai N, Li M, Chen C, He S, Wang G, Xiao H, Li C, Wang D. Transcatheter rectal arterial chemoembolization with oxaliplatin plus S-1 concurrent chemoradiotherapy can improve the pathological remission rate in locally advanced rectal cancer: a comparative study. Radiat Oncol. 2020 May 6;15(1):94. doi: 10.1186/s13014-020-01540-4.
PubMed 32375814
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study of Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in the Management of Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT03601156
- Acronym / sponsor ID
- PCAR / PCAR
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, intraarterial chemoembolization, radiotherpy, Oxaliplatin, Tegafur Gimeracil and Oteracil Porassium Capsule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 26 Jul 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.
Compared to postoperative chemotherapy combined with radiotherapy, preoperative chemotherapy combined with radiotherapy shows higher sphincter preservation rate and lower local recurrence rate in locally advanced rectal cancer. The purpose of this study is to evaluate the response and prognosis of intraarterial chemoembolization and intravenous infusion chemotherapy in patients with rectal T3-T4 and/or N+ rectal cancer before operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NATACE-RT | Experimental | Device: intraarterial chemoembolizationPatients receive Oxaliplatin 130mg/m2 intraarterial chemoembolization on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA < 1.25 mm2 receive 80 mg/day; 1.25 mm2 < BSA < 1.5mm2 recive 100 mg/day, BSA>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks) |
| NACT-RT | Active comparator | Device: intravenous chemotherapyPatients receive Oxaliplatin 130mg/m2 intravenous chemotherapy on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA < 1.25 mm2 receive 80 mg/day; 1.25 mm2 < BSA < 1.5mm2 recive 100 mg/day, BSA>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic or cytologic diagnosis of rectal cancer, Stage IV.
- Males or females between 18 Years to 75 Years.
- No prior cisplatin-based chemotherapy or radiotherapy.
- Performance status of 0～2 on the ECOG criteria.
- Adequate hematologic (Leukocyte count >= 4,000/uL, neutrophil count >= 1,500/uL, hemoglobin >= 10 g/dL, platelets >= 100,000/uL), hepatic (AST \& ALT =< upper normal limit(UNL)x1.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL x1.5 or creatinine clearance rate ≥60 ml/min) function.
Key exclusion criteria (8 listed)
- Patient with allergic to S-1 or ingredient of Oxaliplatin
- Patient with Peripheral neuropathy
- Diagnosed fibrosis of lung;pulmonary fibrosis or interstitial pneumonia within 28 days.
- Medically uncontrolled serious heart, renal failure, liver failure, hemorrhagic peptic ulcer, paralysis of intestine , ileus, poor controlled diabetes.
- Enrollment in other study.
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 |
|---|---|---|
| intraarterial chemoembolization | Device | NATACE-RT |
| intravenous chemotherapy | Device | NACT-RT |
Primary outcome
Pathological Complete Response (pCR)
Time frame: pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy
Pathological complete response (pCR) was determined on tumor resection specimens after completion of neoadjuvant therapy, and was defined as no evidence of residual invasive and ductal disease in the rectum and lymph nodes
6 secondary outcomes
the Sphincter Preservation Rate
Time frame: 3 month
Disease-free survival
Time frame: Following surgery, 5 years
Overall Survival
Time frame: the first day of treatment to death or last survival confirm date; assesed up to 5 years
Down Staging Rate
Time frame: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Number of Participants with Adverse Events
Time frame: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Number of Postoperative Complication
Time frame: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Derived from this study: PubMed 38460248Qian C, Yang W, Li M, Feng Y, Dai N, Luo H, Jian D, Li X, Yang Y, He Y, Wang D, Li C, Xiao H. Negative prognostic impact of Co-mutations in TGFbeta and TP53 pathways in surgically resected rectal tumors following neoadjuvant chemoradiotherapy. Eur J Surg Oncol. 2024 Apr;50(4):108242. doi: 10.1016/j.ejso.2024.108242. Epub 2024 Mar 6.
- Derived from this study: PubMed 32375814Yang B, Shan J, Feng Y, Dai N, Li M, Chen C, He S, Wang G, Xiao H, Li C, Wang D. Transcatheter rectal arterial chemoembolization with oxaliplatin plus S-1 concurrent chemoradiotherapy can improve the pathological remission rate in locally advanced rectal cancer: a comparative study. Radiat Oncol. 2020 May 6;15(1):94. doi: 10.1186/s13014-020-01540-4.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraarterial chemoembolization and intravenous chemotherapy in people with Rectal Cancer, run by Third Military Medical University at 3 sites 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 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 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Dong Wang, PH.D. (86-23-68757151, dongwang64@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy). 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 NCT03601156, which also lists 2 linked publications.
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 10 Aug 2018.