Rectal carcinoma
Conditions
Interventions
mFOLFOX6 (Levofolinate 200 mg/m2, L-OHP 85 mg/m2, 5-FU/bolus 400 mg/m2, 5-FU/continuous 2,400 mg/m2) Alpha beta T cell therapy
Sponsors
Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
Nippon Medical School Hospital Fukuoka University Hospital Seta Clinic Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient musy be diagnosed as adenocarcinoma pathologically including papillary adenocarcinoma, tubular adenocarcinoma, anaplastic adenocarcinoma, colloid carcinoma, signet ring cell adenocarcinoma and medullar cancer, by endoscopic biopsy from primary lesion in rectum. 2) Tumor must exist in either Ra or Rb mainly. 3) Patient must be included one criteria below: a) diagnosed as above cT3 by either abdominal or pelvis contrast-enhanced CT or contrast-enhanced MRI. b) diagnosed as above cN1, that is, lymph mode metastasis has detected by pelvis contrast-enhanced CT with slice thickness of below 5mm. However, patient of cT4b must be excluded if infiltration is suspected to either trigon of bladder, urethra or sacred bone. 4) Patient must be diagnosed bas cM0, that is, distant metastases have not been detected by either chest CT, abdominal or pelvis contrast-enhanced CT or contrast enhanced MRI of slice thickness of below 5mm 5) Patient must be between 20 and 80 years old at registration. 6) Patient must be 0, 1 of ECOG PS score. 7) Patient must have no previous chemotherapy, no proctectomy, but local excision, no pelvis lymphadenectomy for any cancers. 8) Patient must not have multicentric cancer according to comprehensive diagnosis using colonoscopy and imaging, that is barium enema examination or abdomen/pelvis contrast-enhanced CT, or CT colonography. 9) Test results within 14 days before the registration satisfies all the requirements 10) Either abdominal operation or laparoscopic surgery must be planned. 11) Patient must have given written consent to the study
Exclusion criteria
Exclusion criteria: 1) Patient must not have active multiple cancer. Active multiple cancer means concurrent multiple cancer or multi centric cancer and non-concurrent multiple or multi centric cancer which has intervals within 5 years without disease. However carsinoma in situ and intramucosal carcinoma are not included in active cancer as they are curable by local treatment. 2) Patient must not have infectious disease which requires systemic therapy. 3) Patient must not be HIV positive, nor HTLV-1 positive. 4) Patient must not be microsatellite instability (MSI) positive. 5) Patient must not have fever over 38 degrees centigrade at registration. 6) Pregnant woman, woman possible to be pregnant, woman within 28 days after delivery and nursing woman must be excluded. 7) Patient that has mental disorders or neurologic manifestation must be excluded. 8) Patient that continuous whole body oral or intravenous administration of steroid or other immunosuppressive drug 9) Patient that has one or mutiple of diseases among interstitial pneumonia, pulmonary fibrosis, intense pneumonectasia diagnosed by chest CT must be excluded.. 10) Patient that has active autoimmune disease must be excluded. 11) Patient that has diabetes either during continuous insulin treatment or under poor control must be excluded. 12) Patient that has insecurity angina pectoris, that is, angina pectoris which occurs or aggravates within 3 weeks, and patient that has previous heart infarction within 6 months. 13) Patient that doctor(s), either principal researcher or member of the project has judged inappropriate to join this study must be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study aims at evaluating the safety by combination of adjuvant integrated immune-cell therapy for progressive rectal cancer patients with immune-cell therapy using activated lymphocytes and chemotherapy using mFOLFOX6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy | — |
Countries
Japan
Contacts
Public ContactKiichi Sugimoto
Juntendo University Hospital Department of Coloproctological Surgery
Outcome results
None listed