Rectal CancerNARCNCT01271192
Efficacy and Safety Study of Neoadjuvant in Treating Patients With Resectable Local Recurrent Rectal Cancer
A study testing surgical resection and adjuvant therapy and Neoadjuvant followed by operation in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- surgical resection and adjuvant therapy and Neoadjuvant followed by operation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Adenocarcinoma of the rectum
- Age:18-80 years old
- Received curative resection when diagnosed as rectal cancer
- Local recurrence happened >6 months after operation,without distant metastasis
- Local recurrent mass is resectable confirmed by surgeon and radiologist 6.15 days prior recruit, meet the following criteria:
- Hematopoietic
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- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hepatic
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 times ULN
- AST ≤ 2.5 times ULN
- ALT ≤ 2.5 times ULN
- No hepatic disease that would preclude study treatment or follow-up
- No uncontrolled coagulopathy
- Renal
- Creatinine clearance > 50 mL/min
- No renal disease that would preclude study treatment or follow-up
- 7.ECOG status: 0～1
Who cannot join
- Other rectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
- Synchronous colon cancer
- Hypersensitivity to fluorouracil
- No More than 4 weeks since prior participation in any investigational drug study
- Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
- History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
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- Uncontrolled hypertension
- Cardiovascular disease that would preclude study treatment or follow-up
- Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
- Pregnant or nursing, Fertile patients do not use effective contraception
- Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
- No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Pang Lan, M.D., 008613710316769, lpzm@yahoo.com
About this study
Official title: A Randomized Multicenter Clinical Trial of Direct Surgical Resection Compared to Neoadjuvant Followed by Surgical Resection in Treating Patients With Operable Local Recurrent Carcinoma Of The Rectum
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown.
PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
Secondary
- Compare the side effect of chemo radiotherapy according to the Common Toxicity Criteria(CTC) version 2.0 in patients treated with these regimens.
- Compare the postoperative complications in patients treated with these regimens.
- Compare the recurrent rate in patients treated with these regimens.
- Compare the distant metastatic rate in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter clinical trial. Patients are stratified according to participating center, gender, age. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4 weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6 weeks, from 8-12 weeks after operation.
- Arm II: Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI for 7 cycles from 2-4 weeks after operation.
After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for at least 3 years.
The side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate and 5-year survival rate will be investigated.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 5 year.
- Conditions
- Rectal Cancer
- Being tested
- surgical resection and adjuvant therapy, Neoadjuvant followed by operation
- Keywords
- local recurrent rectal cancer, surgical resection, adjuvant therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical resection and adjuvant therapyProcedure or surgery
Postoperative:
Drug: fluorouracil Given IV continuously, Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks
Neoadjuvant followed by operationProcedure or surgery
Preoperative:
Drug: fluorouracil Given IV continuously,Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks
Postoperative:
Drug: fluorouracil Given IV continuously,Irinotecan Given IV
| Study group | Role | What they receive |
|---|---|---|
| Surgical resection and adjuvant therapy | Active comparator | Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4 weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6 weeks, from 8-12 weeks after operation Receives: Procedure: surgical resection and adjuvant therapy |
| Neoadjuvant followed by operation | Experimental | Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI for 7 cycles from 2-4 weeks after operation. Receives: Procedure: Neoadjuvant followed by operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year disease free survival
Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
Measured: 5 years
Secondary outcomes (1)
Side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate,biomarkers, quality of life, toxic profile, convenience
- Compare the postoperative complications in patients treated with these regimens
- Compare the recurrent rate in these patients
- Compare the distant metastatic rate in these patients
- Compare preoperative quality of life (QOL) of patients.
- Compare the toxic effects of these regimens in these patients.
- Compare the convenience of care in patients treated with these regimens
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2015 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Second Military Medical University
- Investigators
- Ping Lan, M.D., Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271192
- Sponsor's protocol ID
- GIHSYSU02
- Acronym
- NARC
- Status last verified
- Dec 2010
- First submitted
- 5 Jan 2011
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Clinical Trial of Direct Surgical Resection Compared to Neoadjuvant Followed by Surgical Resection in Treating Patients With Operable Local Recurrent Carcinoma Of The Rectum
- ClinicalTrials.gov ID
- NCT01271192
- Acronym / sponsor ID
- NARC / GIHSYSU02
- Conditions
- Rectal Cancer
- Keywords
- local recurrent rectal cancer, surgical resection, adjuvant therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Second Military Medical University
- Study start
- Dec 2010
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Jan 2011 (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.
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown.
PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
Secondary
- Compare the side effect of chemo radiotherapy according to the Common Toxicity Criteria(CTC) version 2.0 in patients treated with these regimens.
- Compare the postoperative complications in patients treated with these regimens.
- Compare the recurrent rate in patients treated with these regimens.
- Compare the distant metastatic rate in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter clinical trial. Patients are stratified according to participating center, gender, age. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4 weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6 weeks, from 8-12 weeks after operation.
- Arm II: Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI for 7 cycles from 2-4 weeks after operation.
After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for at least 3 years.
The side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate and 5-year survival rate will be investigated.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 5 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical resection and adjuvant therapy | Active comparator | Procedure: surgical resection and adjuvant therapyPatients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4 weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6 weeks, from 8-12 weeks after operation |
| Neoadjuvant followed by operation | Experimental | Procedure: Neoadjuvant followed by operationPatients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI for 7 cycles from 2-4 weeks after operation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of Adenocarcinoma of the rectum
- Age:18-80 years old
- Received curative resection when diagnosed as rectal cancer
- Local recurrence happened >6 months after operation,without distant metastasis
- Local recurrent mass is resectable confirmed by surgeon and radiologist 6.15 days prior recruit, meet the following criteria:
Key exclusion criteria (12 listed)
- Other rectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
- Synchronous colon cancer
- Hypersensitivity to fluorouracil
- No More than 4 weeks since prior participation in any investigational drug study
- Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
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 |
|---|---|---|
| surgical resection and adjuvant therapyPostoperative: Drug: fluorouracil Given IV continuously, Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks | Procedure or surgery | Surgical resection and adjuvant therapy |
| Neoadjuvant followed by operationPreoperative: Drug: fluorouracil Given IV continuously,Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks Postoperative: Drug: fluorouracil Given IV continuously,Irinotecan Given IV | Procedure or surgery | Neoadjuvant followed by operation |
Primary outcome
5-year disease free survival
Time frame: 5 years
Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
1 secondary outcome
Side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate,biomarkers, quality of life, toxic profile, convenience
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2011.
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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.
Ping Lan, M.D. study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical resection and adjuvant therapy and Neoadjuvant followed by operation in people with Rectal Cancer, run by Sun Yat-sen 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 19 inclusion and 12 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 6 Jan 2011. 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?
Contact Ping Lan, M.D. (008613710316769, lpzm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year disease free survival (time frame: 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 6 Jan 2011.