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RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).

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ClinicalTrials.gov Identifier: NCT02280070
Recruitment Status : Recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Yoshito Akagi, Kurume University

Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer 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) Drug: L-OHP (85 mg/m2) Drug: l-LV Drug: 5-FU Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of SOX vs mFOLFOX6 as Neoadjuvant Chemotherapy in Patients With Resectable Rectal Cancer (KSCC1301).
Study Start Date : September 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Active Comparator: SOX (S-1 + L-OHP)

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

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

Other: Biomarker
Carcinoembryonic antigen and carbohydrate antigen 19-9
Other Name: CEA and CA19-9

Radiation: Contrasting CT
Computed tomography
Other Name: CT

Other: Adverse event
AE was evaluated using Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Other Name: 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: 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 Name: 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 Name: Oxaliplatin

Active Comparator: mFOLFOX6

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

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

Other: Biomarker
Carcinoembryonic antigen and carbohydrate antigen 19-9
Other Name: CEA and CA19-9

Radiation: Contrasting CT
Computed tomography
Other Name: CT

Other: Adverse event
AE was evaluated using Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Other Name: 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-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 Name: Oxaliplatin

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 Name: 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 Name: 5-fluorouracil




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pathological Effect [ Time Frame: After operation, up to 5 years after the last subject enrollment. ]
    The pathological effect of protocol treatment as FAS a denominator is evaluated according to the criteria of Japanese Classification of Colorectal Carcinoma 7th revision

  2. R0 resection rate [ Time Frame: At operation, up to 5 years after the last subject enrollment. ]
    The R0 resection rate is defined as a ratio of case that conducted R0 resection in FAS.

  3. 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. ]
    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

  4. Overall survival (OS) [ Time Frame: Up to 5 years after the last subject enrollment. ]
    Overall survival is defined as a period from an enrollment date to a death from every cause in FAS.

  5. 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. ]
    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.

  6. OS in patients with R0 resection [ Time Frame: At the date of death, up to 5 years after the last subject enrollment. ]
    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.

  7. 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. ]
    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.

  8. Transition rate to Operation [ Time Frame: At the operation, up to 5 years after the last subject enrollment. ]
    The transition rate to operation is defined as the rate of case transited to the resection operation in FAS.

  9. local recurrence rate (per operated population) [ Time Frame: After the operation, up to 5 years after the last subject enrollment. ]
    The local recurrence rate is defined as the recurrence rate of operated population.

  10. Safety [ Time Frame: Within protocol treatment, up to 5 years after the last subject enrollment. ]
    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

  11. Pattern of first recurrence [ Time Frame: At the study completion, up to 5 years after the last subject enrollment. ]
    Pattern of first recurrence is investigated in FAS.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280070


Contacts
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Contact: Yasunori Emi, MD, PhD emi-y@saiseikai-hp.chuo.fukuoka.jp
Contact: Eiji Oki, MD, PhD okieiji@surg2.med.kyusyu-u.ac.jp

Locations
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Japan
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Contact: Eiji Oki, MD, PhD    092-642-5466    okieiji@surg2.med.kyushu-u.ac.jp   
Principal Investigator: Eiji Oki, MD, PhD         
Kurume University Hospital Recruiting
Kurume, Japan, 830-0011
Contact: Yoshito Akagi, MD, PhD         
Principal Investigator: Yoshito Akagi, MD, PhD         
Sponsors and Collaborators
Clinical Research Support Center Kyush
Investigators
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Study Director: Yasunori Emi, MD, PhD Saiseikai Fukuoka General Hospital
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Responsible Party: Yoshito Akagi, Professor, Kurume University
ClinicalTrials.gov Identifier: NCT02280070    
Other Study ID Numbers: KSCC1301
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Keywords provided by Yoshito Akagi, Kurume University:
resectable rectal cancer
SOX
mFOLFOX6
neoadjuvant
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Fluorouracil
Tegafur
Oxaliplatin
Antibodies
Immunoglobulins
Hepatitis C Antibodies
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients