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

NCT02280070 | Unknown Phase 2 DMC

• 1 other identifier: KSCC1301
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Rectal Cancer

Keywords

resectable rectal cancer; SOX; mFOLFOX6; neoadjuvant

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years from the enrollment

Secondary Outcomes (11)

• Pathological Effect

  After operation, up to 5 years after the last subject enrollment.

• R0 resection rate

  At operation, up to 5 years after the last subject enrollment.

• Completion rate of each modality (neoadjuvant chemotherapy, operation and adjuvant chemotherapy)

  After completion of protocol treatment, up to 5 years after the last subject enrollment.

• Overall survival (OS)

  Up to 5 years after the last subject enrollment.

• Disease Free survival (DFS)

  The date of recurrence, occurrence of secondary cancer and death, up to 5 years after the last subject enrollment.

Study Arms (2)

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

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

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

Interventions

Laboratory test OTHER

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

Also known as: Hematologic test and blood chemistry

SOX (S-1 + L-OHP); mFOLFOX6

Medical history and physical examination OTHER

medical history and physical examination

SOX (S-1 + L-OHP); mFOLFOX6

BW and height OTHER

Body weight (kg) and height (cm)

SOX (S-1 + L-OHP); mFOLFOX6

Performance status OTHER

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

Also known as: PS

SOX (S-1 + L-OHP); mFOLFOX6

Creatinine clearance OTHER

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

Also known as: CCr

SOX (S-1 + L-OHP); mFOLFOX6

Biomarker OTHER

Carcinoembryonic antigen and carbohydrate antigen 19-9

Also known as: CEA and CA19-9

SOX (S-1 + L-OHP); mFOLFOX6

Contrasting CT RADIATION

Computed tomography

Also known as: CT

SOX (S-1 + L-OHP); mFOLFOX6

Adverse event OTHER

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

Also known as: AE

SOX (S-1 + L-OHP); mFOLFOX6

HBs antigen and HCV antibody OTHER

check for exclusion criteria

SOX (S-1 + L-OHP); mFOLFOX6

Endoscopy OTHER

Endoscopy for lower digestive tract

SOX (S-1 + L-OHP); mFOLFOX6

HBs antibody and HBc antibody OTHER

Check according to hepatitis B guideline

SOX (S-1 + L-OHP); mFOLFOX6

S-1 DRUG

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.

Also known as: Tegafur, gimeracil, potassium oteracil potassium

SOX (S-1 + L-OHP)

L-OHP (130mg/m2) DRUG

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.

Also known as: Oxaliplatin

SOX (S-1 + L-OHP)

L-OHP (85 mg/m2) DRUG

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.

Also known as: Oxaliplatin

mFOLFOX6

l-LV DRUG

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.

Also known as: l-isomer of leucovorin

mFOLFOX6

5-FU DRUG

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.

Also known as: 5-fluorouracil

mFOLFOX6

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinical Research Support Center Kyush: lead

Study Sites (2)

Kyushu University Hospital

Fukuoka, 812-8582, Japan

RECRUITING

Kurume University Hospital

Kurume, 830-0011, Japan

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Clinical Laboratory Techniques; Hematologic Tests; Blood Chemical Analysis; Health Records, Personal; Restraint, Physical; Body Height; Karnofsky Performance Status; Biomarkers; CA-19-9 Antigen; Hepatitis C Antibodies; Endoscopy; S 1 (combination); Tegafur; gimeracil; Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Clinical Chemistry Tests; Medical Records; Records; Data Collection; Epidemiologic Methods; Behavior Control; Therapeutics; Immobilization; Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Physical Appearance, Body; Anthropometry; Physiological Phenomena; Growth; Growth and Development; Severity of Illness Index; Patient Acuity; Health Status Indicators; Health Surveys; Surveys and Questionnaires; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Biological Factors; Antigens, Tumor-Associated, Carbohydrate; Antigens, Neoplasm; Antigens; Lewis Blood Group Antigens; Blood Group Antigens; Antigens, Surface; Epitopes; Isoantigens; Biomarkers, Tumor; Hepatitis Antibodies; Antibodies, Viral; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Yasunori Emi, MD, PhD

  Saiseikai Fukuoka General Hospital

  STUDY DIRECTOR

Central Study Contacts

Yasunori Emi, MD, PhD

CONTACT

emi-y@saiseikai-hp.chuo.fukuoka.jp

Eiji Oki, MD, PhD

CONTACT

okieiji@surg2.med.kyusyu-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 31, 2014
• Study Start: September 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2020
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

JP (2)