Rectal CancerPhase 2NCT02280070
RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).
A Phase 2 study testing Laboratory test, Medical history and physical examination and BW and height in people with Rectal Cancer, run by Clinical Research Support Center Kyush at 2 sites in Japan.
Trial summary
To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Laboratory test, Medical history and physical examination and BW and height
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2013to Aug 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Patients who are judged to be suitable for receiving this protocol therapy by physician
- Distal border of tumor is located under the peritoneal reflection
- Histologically confirmed rectal adenocarcinoma
- Previously untreated rectal cancer
- Within 28 days before registration, the tumor is considered by the surgeon to be amenable to curative resection [T category: cSS and cSE, cSI, cA, cAI. N category: cN0-2 and cN3(#253 lymph node)]
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- Within 28 days before registration, there is no evidence of distant metastasis by contrast-enhanced CT
- >= 20 years old
- PS (ECOG) 0-1
- Be able to take oral drugs
- Required baseline laboratory parameters (within 14 days before registration): WBC >= 3000 ,<12000/mm3, Neu >= 1,500/ mm3, Hb >= 9.0g/dl, Plt >= 100,000/ mm3, T-Bil <= 2.0mg/dl, AST,ALT <= 100U/L, Cre <1.5mg/dl, Ccr >= 60mL/min
- Considered to survive for more than 3 months
Who cannot join
- History of serious drug hypersensitivity or a history of drug allergy
- Pregnant or lactating woman and man who hope for Partner's pregnant
- Active infection(over 38 degree)
- Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, serious diabetes, serious hypertension)
- Clinically significant abnormal electrocardiogram or heart disease
- Serious diarrhea
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- Pleural effusion, peritoneal fluid that needs treatment
- Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema )
- Hemorrhagic diathesis, coagulation disorder
- Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less)
- Patients who need flucytosine, phenytoin or warfarin potassium
- Requiring steroid drug
- Patients with contraindication to therapy
- History of allergy to contrast material
- Serious stricture (exclude the patients who are put in stoma)
- Positive for HBs antigen and HCV antibody
- Not appropriate for the study at the physician's assessment
Trial locations and contacts
2 sites in 1 country.
Yasunori Emi, MD, PhD contact
Eiji Oki, MD, PhD contact
Japan2 sites, 2 recruiting
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
Eiji Oki, MD, PhD, 092-642-5466, okieiji@surg2.med.kyushu-u.ac.jp
Eiji Oki, MD, PhD
- Recruiting
Kurume University Hospital
Kurume, 830-0011
Yoshito Akagi, MD, PhD
Yoshito Akagi, MD, PhD
About this study
Official title: Randomized Phase II Study of SOX vs mFOLFOX6 as Neoadjuvant Chemotherapy in Patients With Resectable Rectal Cancer (KSCC1301).
To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.
Read the detailed description
- Patient registration procedure
If it is confirmed that the subject meets the inclusion criteria and correspondent none of the exclusion criteria, the subject is registered by using CReS Kyushu registration/allocation system (CK-RAS). The registration with CK-RAS is available for 24hr (URL: https://reg.cres-kyushu.or.jp/qmin/login/) and needs for individual ID and password.
- Quality management
- Monitoring A central monitoring or in-site monitoring are carried out based on the data from case report form (CRF) collecting at data coordinating center. In principle, an on-site monitoring is not carried out, but it may be carried out when the on-site monitoring is determined to need by Kyushu Study group of Clinical Cancer (KSCC) steering committee from the results of the central monitoring so on.
- Data Monitoring Committee A Data Monitoring Committee (DMC) has been established.
- Data entry All data will be entered by the double entry method. Referential data rules, valid values, range checks, and consistency checks against data already stored in the database will be supported. Checks will be applied at the time of data entry into a specific field. Additional errors will be detected by programs designed to detect missing data or specific errors in the data. The investigator who receives the inquiry will respond by checking the original forms for inconsistency, checking other sources to determine the correction, modifying the original paper form entering a response to the query.
- Regular monitoring report A regular monitoring report generated by data coordinating center is submitted to KSCC Steering Committee, principal investigator, the DMC etc and it is reviewed according to "KSCC regulation on the monitoring". The information on the status of site EC approval and the achievement of enrollment: number of enrollment- total/per periodical, total/per site, is reported monthly using e-mail.
- Contents of monitoring report
- Study abstract: schema/purpose/subject/endpoint/definition of treatment/anticipated enrollment number/progress of the study
- Enrollment status: per participating site/total
- Monitoring activity: contents of activity/CRF collection per site/uncollected CRF, inquiry
- Review of the eligible treatment case：the case of ineligible possibility/the case determined as ineligible/number of eligible case/the case determined as non-treatment/total number of treatment case
- Review of a target population for analysis: the number of cases targeted for efficacy analysis/safety analysis
- Patient background
- Treatment time-course: summary of on-treatment and discontinuation/summary of reason for discontinuation/list of reason for discontinuation
- Protocol violation/deviation
- Safety evaluation: serious adverse reaction, event/the case which was notified to the study group among the adverse reactions, events with an ordinary report/general adverse events
- Others
- Audit
A site audit is carried out by the audit members of KSCC Coordinating Center, data coordinating center, medical staff of other site under the approval of the site director according to "KSCC regulation for site audit". The results of the audit are reported to the site director, KSCC Steering Committee, principal investigator etc. (if required, to DMC).
- Conditions
- Rectal Cancer
- Being tested
- Laboratory test, Medical history and physical examination, BW and height, Performance status, Creatinine clearance
- Keywords
- resectable rectal cancer, SOX, mFOLFOX6, neoadjuvant
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory testOther
Also called Hematologic test and blood chemistry
Leukocyte, neutrophil (ANC ：stab + seg), hemoglobin, platlet, albumin, total birrilubin, AST, ALT, LDH, Creatinine, Na, K, CRP, fast blood sugar
Medical history and physical examinationOther
medical history and physical examination
BW and heightOther
Body weight (kg) and height (cm)
Performance statusOther
Also called PS
ECOG performance status, 0: Fully active, able to carry on all pre-disease performance without restriction, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5: Dead
Creatinine clearanceOther
Also called CCr
Creatinine clearance (CCr, mL/min) was estimated by Cockcroft \& Gault method using serum creatinine (mg/dL), age and body weight (kg).
BiomarkerOther
Also called CEA and CA19-9
Carcinoembryonic antigen and carbohydrate antigen 19-9
Contrasting CTRadiation
Also called CT
Computed tomography
Adverse eventOther
Also called AE
AE was evaluated using Common Terminology Criteria for Adverse Events (CTCAE v4.0).
HBs antigen and HCV antibodyOther
check for exclusion criteria
EndoscopyOther
Endoscopy for lower digestive tract
HBs antibody and HBc antibodyOther
Check according to hepatitis B guideline
S-1Drug
Also called Tegafur, gimeracil, potassium oteracil potassium
S-1 (80 mg/m2, p.o.) is administered at day 1 -14 of the course and repeated every 3 weeks until 4 courses or meet discontinuation criteria.
L-OHP (130mg/m2)Drug
Also called Oxaliplatin
L-OHP (130mg/m2 intravenously) is administered at day 1 of the course and repeated every 3 weeks until 4 courses or meet discontinuation criteria.
L-OHP (85 mg/m2)Drug
Also called Oxaliplatin
L-OHP (85mg/m2) is administered by IV infusion drip for 2hr at day 1 of the course and repeated every 2 weeks until 6 courses or meet discontinuation criteria.
l-LVDrug
Also called l-isomer of leucovorin
l-LV (200 mg/m2) is administered by IV infusion drip for 2hr at day 1 of the course and repeated every 2 weeks until 6 courses or meet discontinuation criteria.
5-FUDrug
Also called 5-fluorouracil
5-FU (400 mg/m2) by bolus IV administration just after the L-OHP and l-LV administration. 5-FU (2,400 mg/m2) by IV continuous infusion for 46 hours using infuser pump afterwards and repeated every 2 weeks until 6 courses or meet discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| SOX (S-1 + L-OHP) | Active comparator | S-1 (80 mg/m2, p.o.) (day1-14）, L-OHP (130 mg/m2)(day 1): repeated every 3 weeks until 4 courses or meet discontinuation criteria.
Medical history and physical examination, BW and height, performance status, laboratory test, creatinine clearance, biomarker, contrasting CT, adverse event, HBs antigen and HCV antibody, endoscopy, HBs antibody and HBc antibody Receives: Other: Laboratory test; Other: Medical history and physical examination; Other: BW and height; Other: Performance status; Other: Creatinine clearance; Other: Biomarker; Radiation: Contrasting CT; Other: Adverse event; Other: HBs antigen and HCV antibody; Other: Endoscopy; Other: HBs antibody and HBc antibody; Drug: S-1; Drug: L-OHP (130mg/m2) |
| mFOLFOX6 | Active comparator | L-OHP (85 mg/m2) and l-LV (200 mg/m2) by IV infusion drip for 2hr at day 1. 5-FU (400 mg/m2) by bolus IV administration just after the L-OHP and l-LV administration. 5-FU (2,400 mg/m2) by IV continuous infusion for 46 hours using infuser pump afterwards (day 1-2: repeated every 2 weeks until 6 courses or meet discontinuation criteria.
Medical history and physical examination, BW and height, performance status, laboratory test, creatinine clearance, biomarker, contrasting CT, adverse event, HBs antigen and HCV antibody, endoscopy, HBs antibody and HBc antibody Receives: Other: Laboratory test; Other: Medical history and physical examination; Other: BW and height; Other: Performance status; Other: Creatinine clearance; Other: Biomarker; Radiation: Contrasting CT; Other: Adverse event; Other: HBs antigen and HCV antibody; Other: Endoscopy; Other: HBs antibody and HBc antibody; Drug: L-OHP (85 mg/m2); Drug: l-LV; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-years Disease Free Survival rate
The last analysis after the follow-up period is conducted. The disease-free survival ratio that assumed full analysis set (FAS) as a denominator is estimating by Kaplan-Meier method at 3 year, up to 5 years after the last subject enrollment.
Measured: 3 years from the enrollment
Secondary outcomes (11)
Pathological Effect
The pathological effect of protocol treatment as FAS a denominator is evaluated according to the criteria of Japanese Classification of Colorectal Carcinoma 7th revision
Measured: After operation, up to 5 years after the last subject enrollment.
R0 resection rate
The R0 resection rate is defined as a ratio of case that conducted R0 resection in FAS.
Measured: At operation, up to 5 years after the last subject enrollment.
Completion rate of each modality (neoadjuvant chemotherapy, operation and adjuvant chemotherapy)
The rate completed 4 courses of neo-adjuvant chemotherapy within protocol treatment is defined as the completion rate of neo-adjuvant therapy in FAS. Among the cases that an resection operation are enforced and that adjuvant chemotherapy is planned after the operation, the rate completed 4 courses of adjuvant chemotherapy within protocol treatment is defined as the completion rate of adjuvant therapy
Measured: After completion of protocol treatment, up to 5 years after the last subject enrollment.
Overall survival (OS)
Overall survival is defined as a period from an enrollment date to a death from every cause in FAS.
Measured: Up to 5 years after the last subject enrollment.
Disease Free survival (DFS)
DFS is defined as the period from a registration day to the day of recurrence, the day of diagnosis of secondary cancer and the day of the death of every cause in FAS.
Measured: The date of recurrence, occurrence of secondary cancer and death, up to 5 years after the last subject enrollment.
OS in patients with R0 resection
OS in patients with R0 resection is defined as a period from a enrollment day to the date of death from every cause in patients with R0 resection in FAS.
Measured: At the date of death, up to 5 years after the last subject enrollment.
DFS in patients with R0 resection
DFS in patients with R0 resection is defined as the period from a enrollment day to the day of recurrence, the day of diagnosis of secondary cancer and the day of the death of every cause in patients with R0 resection in FAS.
Measured: The date of recurrence, occurrence of secondary cancer and death, up to 5 years after the last subject enrollment.
Transition rate to Operation
The transition rate to operation is defined as the rate of case transited to the resection operation in FAS.
Measured: At the operation, up to 5 years after the last subject enrollment.
local recurrence rate (per operated population)
The local recurrence rate is defined as the recurrence rate of operated population.
Measured: After the operation, up to 5 years after the last subject enrollment.
Safety
The frequency of worst Grade of the adverse event (toxicity) in all courses with the CTCAE v4.0 Japanese translated JCOG version is calculated in each group about the cases for the safety analysis a denominator
Measured: Within protocol treatment, up to 5 years after the last subject enrollment.
Pattern of first recurrence
Pattern of first recurrence is investigated in FAS.
Measured: At the study completion, up to 5 years after the last subject enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2018 (estimated)
- Study completionAug 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.
- 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Support Center Kyush
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshito Akagi, Kurume University
- Investigators
- Yasunori Emi, MD, PhD, Study director, Saiseikai Fukuoka General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280070
- Sponsor's protocol ID
- KSCC1301
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of SOX vs mFOLFOX6 as Neoadjuvant Chemotherapy in Patients With Resectable Rectal Cancer (KSCC1301).
- ClinicalTrials.gov ID
- NCT02280070
- Acronym / sponsor ID
- KSCC1301
- Conditions
- Rectal Cancer
- Keywords
- resectable rectal cancer, SOX, mFOLFOX6, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Clinical Research Support Center KyushUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 31 Oct 2014 (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.
To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.
Detailed description
- Patient registration procedure
If it is confirmed that the subject meets the inclusion criteria and correspondent none of the exclusion criteria, the subject is registered by using CReS Kyushu registration/allocation system (CK-RAS). The registration with CK-RAS is available for 24hr (URL: https://reg.cres-kyushu.or.jp/qmin/login/) and needs for individual ID and password.
- Quality management
- Monitoring A central monitoring or in-site monitoring are carried out based on the data from case report form (CRF) collecting at data coordinating center. In principle, an on-site monitoring is not carried out, but it may be carried out when the on-site monitoring is determined to need by Kyushu Study group of Clinical Cancer (KSCC) steering committee from the results of the central monitoring so on.
- Data Monitoring Committee A Data Monitoring Committee (DMC) has been established.
- Data entry All data will be entered by the double entry method. Referential data rules, valid values, range checks, and consistency checks against data already stored in the database will be supported. Checks will be applied at the time of data entry into a specific field. Additional errors will be detected by programs designed to detect missing data or specific errors in the data. The investigator who receives the inquiry will respond by checking the original forms for inconsistency, checking other sources to determine the correction, modifying the original paper form entering a response to the query.
- Regular monitoring report A regular monitoring report generated by data coordinating center is submitted to KSCC Steering Committee, principal investigator, the DMC etc and it is reviewed according to "KSCC regulation on the monitoring". The information on the status of site EC approval and the achievement of enrollment: number of enrollment- total/per periodical, total/per site, is reported monthly using e-mail.
- Contents of monitoring report
- Study abstract: schema/purpose/subject/endpoint/definition of treatment/anticipated enrollment number/progress of the study
- Enrollment status: per participating site/total
- Monitoring activity: contents of activity/CRF collection per site/uncollected CRF, inquiry
- Review of the eligible treatment case：the case of ineligible possibility/the case determined as ineligible/number of eligible case/the case determined as non-treatment/total number of treatment case
- Review of a target population for analysis: the number of cases targeted for efficacy analysis/safety analysis
- Patient background
- Treatment time-course: summary of on-treatment and discontinuation/summary of reason for discontinuation/list of reason for discontinuation
- Protocol violation/deviation
- Safety evaluation: serious adverse reaction, event/the case which was notified to the study group among the adverse reactions, events with an ordinary report/general adverse events
- Others
- Audit
A site audit is carried out by the audit members of KSCC Coordinating Center, data coordinating center, medical staff of other site under the approval of the site director according to "KSCC regulation for site audit". The results of the audit are reported to the site director, KSCC Steering Committee, principal investigator etc. (if required, to DMC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOX (S-1 + L-OHP) | Active comparator | Other: Laboratory test, Other: Medical history and physical examination, Other: BW and height, Other: Performance status, Other: Creatinine clearance, Other: Biomarker, Radiation: Contrasting CT, Other: Adverse event, Other: HBs antigen and HCV antibody, Other: Endoscopy, Other: HBs antibody and HBc antibody, Drug: S-1, Drug: L-OHP (130mg/m2)S-1 (80 mg/m2, p.o.) (day1-14）, L-OHP (130 mg/m2)(day 1): repeated every 3 weeks until 4 courses or meet discontinuation criteria. Medical history and physical examination, BW and height, performance status, laboratory test, creatinine clearance, biomarker, contrasting CT, adverse event, HBs antigen and HCV antibody, endoscopy, HBs antibody and HBc antibody |
| mFOLFOX6 | Active comparator | Other: Laboratory test, Other: Medical history and physical examination, Other: BW and height, Other: Performance status, Other: Creatinine clearance, Other: Biomarker, Radiation: Contrasting CT, Other: Adverse event, Other: HBs antigen and HCV antibody, Other: Endoscopy, Other: HBs antibody and HBc antibody, Drug: L-OHP (85 mg/m2), Drug: l-LV, Drug: 5-FUL-OHP (85 mg/m2) and l-LV (200 mg/m2) by IV infusion drip for 2hr at day 1. 5-FU (400 mg/m2) by bolus IV administration just after the L-OHP and l-LV administration. 5-FU (2,400 mg/m2) by IV continuous infusion for 46 hours using infuser pump afterwards (day 1-2: repeated every 2 weeks until 6 courses or meet discontinuation criteria. Medical history and physical examination, BW and height, performance status, laboratory test, creatinine clearance, biomarker, contrasting CT, adverse event, HBs antigen and HCV antibody, endoscopy, HBs antibody and HBc antibody |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent
- Patients who are judged to be suitable for receiving this protocol therapy by physician
- Distal border of tumor is located under the peritoneal reflection
- Histologically confirmed rectal adenocarcinoma
- Previously untreated rectal cancer
Key exclusion criteria (17 listed)
- History of serious drug hypersensitivity or a history of drug allergy
- Pregnant or lactating woman and man who hope for Partner's pregnant
- Active infection(over 38 degree)
- Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, serious diabetes, serious hypertension)
- Clinically significant abnormal electrocardiogram or heart 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 |
|---|---|---|
| Laboratory testAlso: Hematologic test and blood chemistryLeukocyte, neutrophil (ANC ：stab + seg), hemoglobin, platlet, albumin, total birrilubin, AST, ALT, LDH, Creatinine, Na, K, CRP, fast blood sugar | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| Medical history and physical examinationmedical history and physical examination | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| BW and heightBody weight (kg) and height (cm) | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| Performance statusAlso: PSECOG performance status, 0: Fully active, able to carry on all pre-disease performance without restriction, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5: Dead | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| Creatinine clearanceAlso: CCrCreatinine clearance (CCr, mL/min) was estimated by Cockcroft \& Gault method using serum creatinine (mg/dL), age and body weight (kg). | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| BiomarkerAlso: CEA and CA19-9Carcinoembryonic antigen and carbohydrate antigen 19-9 | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| Contrasting CTAlso: CTComputed tomography | Radiation | SOX (S-1 + L-OHP), mFOLFOX6 |
| Adverse eventAlso: AEAE was evaluated using Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| HBs antigen and HCV antibodycheck for exclusion criteria | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| EndoscopyEndoscopy for lower digestive tract | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| HBs antibody and HBc antibodyCheck according to hepatitis B guideline | Other | SOX (S-1 + L-OHP), mFOLFOX6 |
| S-1Also: Tegafur, gimeracil, potassium oteracil potassiumS-1 (80 mg/m2, p.o.) is administered at day 1 -14 of the course and repeated every 3 weeks until 4 courses or meet discontinuation criteria. | Drug | SOX (S-1 + L-OHP) |
| L-OHP (130mg/m2)Also: OxaliplatinL-OHP (130mg/m2 intravenously) is administered at day 1 of the course and repeated every 3 weeks until 4 courses or meet discontinuation criteria. | Drug | SOX (S-1 + L-OHP) |
| L-OHP (85 mg/m2)Also: OxaliplatinL-OHP (85mg/m2) is administered by IV infusion drip for 2hr at day 1 of the course and repeated every 2 weeks until 6 courses or meet discontinuation criteria. | Drug | mFOLFOX6 |
| l-LVAlso: l-isomer of leucovorinl-LV (200 mg/m2) is administered by IV infusion drip for 2hr at day 1 of the course and repeated every 2 weeks until 6 courses or meet discontinuation criteria. | Drug | mFOLFOX6 |
| 5-FUAlso: 5-fluorouracil5-FU (400 mg/m2) by bolus IV administration just after the L-OHP and l-LV administration. 5-FU (2,400 mg/m2) by IV continuous infusion for 46 hours using infuser pump afterwards and repeated every 2 weeks until 6 courses or meet discontinuation criteria. | Drug | mFOLFOX6 |
Primary outcome
3-years Disease Free Survival rate
Time frame: 3 years from the enrollment
The last analysis after the follow-up period is conducted. The disease-free survival ratio that assumed full analysis set (FAS) as a denominator is estimating by Kaplan-Meier method at 3 year, up to 5 years after the last subject enrollment.
11 secondary outcomes
Pathological Effect
Time frame: After operation, up to 5 years after the last subject enrollment.
R0 resection rate
Time frame: At operation, up to 5 years after the last subject enrollment.
Completion rate of each modality (neoadjuvant chemotherapy, operation and adjuvant chemotherapy)
Time frame: After completion of protocol treatment, up to 5 years after the last subject enrollment.
Overall survival (OS)
Time frame: Up to 5 years after the last subject enrollment.
Disease Free survival (DFS)
Time frame: The date of recurrence, occurrence of secondary cancer and death, up to 5 years after the last subject enrollment.
OS in patients with R0 resection
Time frame: At the date of death, up to 5 years after the last subject enrollment.
DFS in patients with R0 resection
Time frame: The date of recurrence, occurrence of secondary cancer and death, up to 5 years after the last subject enrollment.
Transition rate to Operation
Time frame: At the operation, up to 5 years after the last subject enrollment.
local recurrence rate (per operated population)
Time frame: After the operation, up to 5 years after the last subject enrollment.
Safety
Time frame: Within protocol treatment, up to 5 years after the last subject enrollment.
Pattern of first recurrence
Time frame: At the study completion, up to 5 years after the last subject enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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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.
Yasunori Emi, MD, PhD contact
Eiji Oki, MD, PhD contact
Yasunori Emi, MD, PhD study director
Saiseikai Fukuoka General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory test, Medical history and physical examination and BW and height in people with Rectal Cancer, run by Clinical Research Support Center Kyush at 2 sites in Japan.
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 12 inclusion and 17 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 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 Yasunori Emi, MD, PhD (emi-y@saiseikai-hp.chuo.fukuoka.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-years Disease Free Survival rate (time frame: 3 years from the enrollment). 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 31 Oct 2014.