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FOLFIRI3 plus panitumumab or FOLFIRI3 plus bevacizumab as consolidation chemotherapy after preoperative chemoradiotherapy in patients with locally advanced rectal cancer; a phase II trial (consolidation trial)

Consolidation chemotherapy after chemoradiotherapy for rectal cancer (consolidation trial)

Matsubara Hisahiro

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba, Japan

matsuhm@faculty.chiba-u.jp

Imanishi Shunsuke

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba, Japan

+81-432262109

shun_imanishi@chiba-u.jp

Recruiting

April. 20, 2019

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) Rectal cancer at the lower edge of the tumor up to Rb
2) The primary rectum is diagnosed histologically as adenocarcinoma.
3) The stage before preoperative treatment is cT3-4 N-any M0 or cT1-2 N1-3 M0
4) Age at the time of study registration is over 20 years old and 75 years old
5) Performance Status (ECOG) is either 0 or 1
6) No history of chemotherapy or pelvic radiation therapy.
7) Have sufficient organ function.
(1) White blood cell count> 3,000 / mm3
(2) platelets> 100,000 / mm3
(3) Hemoglobin> 8.0 g / dl
(4) AST <100 IU / L
(5) ALT <100 IU / L
(6) Total bilirubin <2.0 mg / dl
(7) Cr <1.5 mg / dl
(8) Prothrombin time (activity)> 50%
8) Written informed consent has been obtained from patients themselves regarding study participation.

1) Active multiple cancer, double cancer (synchronous double cancer and double cancer with disease-free period within 5 years). However, lesions equivalent to carcinoma in situ or mucosal carcinoma that are judged to be cured by local treatment are not included in active multiple / dual cancer.
2) Cases with the following serious complications
(1) Cases with psychotic or psychiatric symptoms that are judged to be unsuitable for participation in this study.
(2) Uncontrolled diabetes
(3) Uncontrolled hypertension
(4) Interstitial pneumonia, pulmonary fibrosis, severe emphysema
3) Chronic active hepatitis B or C virus positive cases
4) Cases in which either UGT1A1 * 6 or UGT1A1 * 28 is homozygous or both heterozygous
5) Cases judged as inappropriate by the doctor.

Both

rectal cancer

[RAS wild group]
Total of 4 courses of 3 therapies of FOLFIRI + Panitumumab method of treatment will be performed as reinforcement chemotherapy from 5 weeks later after the chemical radiotherapy.

[RAS mutation group]
Total of 4 courses of 3 therapies of FOLFIRI + Bevacizumab method of treatment will be performed as reinforcement chemotherapy from 5 weeks later after the chemical radiotherapy.

rectal cancer

012

Clinical complete response rate

[The secondary evaluation item of the effectivity]
The pathological effectual rate
The whole life time in 3 and 3 year recurrence survival rate and 3 year accumulation local recurrence rate-lessness
R0 removal rate, the CRM negative rate (1 mm of>=), the pDM negative rate (>0mm) and the pathological therapeutic effect
The defecation function (CCFIS) Urination function (IPSS) QOL (EORTC QLQ-CR38)

[The secondary evaluation item of the safety]
The treatment accomplishment rate and the adverse event occurrence rate

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