Rectal CancerPhase 2/3NCT01064999
A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
A Phase 2/3 study testing Oxaliplatin, Capecitabine and Radiotherapy in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal cancer. Pathological complete response (pCR) is an important prognostic factor for local control and survival. A high intensity CRT increases not only the pCR rate, but also toxicity, especially diarrhea. 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?
- Oxaliplatin, Capecitabine and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Dec 2014
- Phase
- Phase 2/3
- 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
- Patients with rectal adenocarcinoma
- Clinical staged T3/4 or any node-positive disease
- Age: 18-75 years
- Karnofsky Performance Status > 80
- Adequate bone marrow reserve, renal and hepatic functions
- Without previous antitumoural chemotherapy
- No evidence of metastatic disease
- Written informed consent before randomization
Who cannot join
- Previous pelvis radiotherapy.
- Previous antitumoural chemotherapy
- Clinically significant internal disease
Trial locations and contacts
1 site in 1 country.
Ji Zhu, MD contact
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Zhen Zhang, MD
Ji Zhu, MD
About this study
Official title: An Open Label, Randomized, Multi-center, Phase II/III Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy With Intensity-modified Radiation Therapy (IMRT) in Local Advanced Rectal Cancer
Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal cancer. Pathological complete response (pCR) is an important prognostic factor for local control and survival. A high intensity CRT increases not only the pCR rate, but also toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8 weeks after CRT.
- Conditions
- Rectal Cancer
- Being tested
- Oxaliplatin, Capecitabine, Radiotherapy, Surgery
- Keywords
- Neoadjuvant chemotherapy, locally advanced rectal cancer, intensity-modulated radiation therapy, pathological complete response
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
CRT:50mg/m2,IV,weekly*5 cycle CT: 130mg/m2,IV,d1,q 21 day
CapecitabineDrug
CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks
RadiotherapyRadiation
High intensity group:55Gy Low intensity group:50Gy
SurgeryProcedure or surgery
Lower anterior resection or abdominoperineal resection
| Study group | Role | What they receive |
|---|---|---|
| High intensity group | Experimental | (RT 55Gy + CapOx) + a cycle of Xelox + Surgery Receives: Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Radiotherapy; Procedure: Surgery |
| Low instensity group | Active comparator | (RT 50Gy + CapOx) + Surgery Receives: Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Radiotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of pathological complete response (pCR)
Measured: within 14days after surgery
toxicity
Measured: every week during radiotherapy
Secondary outcomes (3)
local recurrence
Measured: every half year after surgery
disease-free survival
Measured: every half year after surgery
overall survival
Measured: every half year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionDec 2014 (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 Rectal 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, First People Hospital of Zhejiang, RenJi Hospital
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064999
- Sponsor's protocol ID
- FDRT-002
- Status last verified
- Mar 2012
- First submitted
- 5 Feb 2010
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang J, Guan Y, Gu W, Yan S, Zhou J, Huang D, Tong T, Li C, Cai S, Zhang Z, Zhu J. Long-course neoadjuvant chemoradiotherapy with versus without a concomitant boost in locally advanced rectal cancer: a randomized, multicenter, phase II trial (FDRT-002). Radiat Oncol. 2019 Nov 29;14(1):215. doi: 10.1186/s13014-019-1420-z.
PubMed 31783766
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Multi-center, Phase II/III Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy With Intensity-modified Radiation Therapy (IMRT) in Local Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT01064999
- Acronym / sponsor ID
- FDRT-002
- Conditions
- Rectal Cancer
- Keywords
- Neoadjuvant chemotherapy, locally advanced rectal cancer, intensity-modulated radiation therapy, pathological complete response
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, First People Hospital of Zhejiang, RenJi Hospital
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 9 Feb 2010 (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 (CRT) has been the standard therapy for local advanced rectal cancer. Pathological complete response (pCR) is an important prognostic factor for local control and survival. A high intensity CRT increases not only the pCR rate, but also toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8 weeks after CRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity group | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Radiation: Radiotherapy, Procedure: Surgery(RT 55Gy + CapOx) + a cycle of Xelox + Surgery |
| Low instensity group | Active comparator | Drug: Oxaliplatin, Drug: Capecitabine, Radiation: Radiotherapy, Procedure: Surgery(RT 50Gy + CapOx) + Surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with rectal adenocarcinoma
- Clinical staged T3/4 or any node-positive disease
- Age: 18-75 years
- Karnofsky Performance Status > 80
- Adequate bone marrow reserve, renal and hepatic functions
Key exclusion criteria (3 listed)
- Previous pelvis radiotherapy.
- Previous antitumoural chemotherapy
- Clinically significant internal disease
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 |
|---|---|---|
| OxaliplatinCRT:50mg/m2,IV,weekly*5 cycle CT: 130mg/m2,IV,d1,q 21 day | Drug | High intensity group, Low instensity group |
| CapecitabineCRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks | Drug | High intensity group, Low instensity group |
| RadiotherapyHigh intensity group:55Gy Low intensity group:50Gy | Radiation | High intensity group, Low instensity group |
| SurgeryLower anterior resection or abdominoperineal resection | Procedure or surgery | High intensity group, Low instensity group |
Primary outcome
the rate of pathological complete response (pCR)
Time frame: within 14days after surgery
toxicity
Time frame: every week during radiotherapy
3 secondary outcomes
local recurrence
Time frame: every half year after surgery
disease-free survival
Time frame: every half year after surgery
overall survival
Time frame: every half year 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 Mar 2012.
- Derived from this study: PubMed 31783766Wang J, Guan Y, Gu W, Yan S, Zhou J, Huang D, Tong T, Li C, Cai S, Zhang Z, Zhu J. Long-course neoadjuvant chemoradiotherapy with versus without a concomitant boost in locally advanced rectal cancer: a randomized, multicenter, phase II trial (FDRT-002). Radiat Oncol. 2019 Nov 29;14(1):215. doi: 10.1186/s13014-019-1420-z.
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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.
Ji Zhu, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxaliplatin, Capecitabine and Radiotherapy in people with Rectal Cancer, 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 8 inclusion and 3 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 Mar 2012. 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 combined 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.
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 Ji Zhu, MD (leo.zhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of pathological complete response (pCR) (time frame: within 14days after surgery). 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 NCT01064999, 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 14 Mar 2012.