Title

RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).
Randomized Phase II Study of SOX vs mFOLFOX6 as Neoadjuvant Chemotherapy in Patients With Resectable Rectal Cancer (KSCC1301).
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Unknown status
  • Intervention/Treatment

    creatinine fluorouracil s-1 gimeracil oteracil oxaliplatin tegafur levoleucovorin ...
  • Study Participants

    110
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.
1. 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.

2. 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 Started
Sep 30
2013
Primary Completion
Aug 31
2018
Anticipated
Study Completion
Aug 31
2020
Anticipated
Last Update
Oct 31
2014
Estimate

Drug L-OHP (85 mg/m2)

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.

  • Other names: Oxaliplatin

Drug S-1

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.

  • Other names: Tegafur, gimeracil, potassium oteracil potassium

Drug L-OHP (130mg/m2)

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.

  • Other names: Oxaliplatin

Other Laboratory test

Leukocyte, neutrophil (ANC :stab + seg), hemoglobin, platlet, albumin, total birrilubin, AST, ALT, LDH, Creatinine, Na, K, CRP, fast blood sugar

  • Other names: Hematologic test and blood chemistry

Other Medical history and physical examination

medical history and physical examination

Other BW and height

Body weight (kg) and height (cm)

Other Performance status

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

  • Other names: PS

Other Creatinine clearance

Creatinine clearance (CCr, mL/min) was estimated by Cockcroft & Gault method using serum creatinine (mg/dL), age and body weight (kg).

  • Other names: CCr

Other Biomarker

Carcinoembryonic antigen and carbohydrate antigen 19-9

  • Other names: CEA and CA19-9

Radiation Contrasting CT

Computed tomography

  • Other names: CT

Other Adverse event

AE was evaluated using Common Terminology Criteria for Adverse Events (CTCAE v4.0).

  • Other names: AE

Other HBs antigen and HCV antibody

check for exclusion criteria

Other Endoscopy

Endoscopy for lower digestive tract

Other HBs antibody and HBc antibody

Check according to hepatitis B guideline

Drug l-LV

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.

  • Other names: l-isomer of leucovorin

Drug 5-FU

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.

  • Other names: 5-fluorouracil

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

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

Criteria

Inclusion Criteria:

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)]
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

Exclusion Criteria:

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
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
No Results Posted