Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer

Preoperative radiotherapy followed by total mesorectal excision (TME) has been recommended as the preferred treatment method for locally advanced rectal cancer. Similar rates of local control, survival and toxicity were observed in preoperative long-course radiotherapy (LCRT) (45-50.4 Gy in 25-28 fractions) and short-course radiotherapy (SCRT) of 25 Gy in five fractions. For the convenience of SCRT, a growing number of patients tend to receive SCRT as preoperative radiotherapy. Although SCRT can shorten treatment interval and cut down the cost of treatment, it's pathological complete response (pCR) rate is relatively low (SCRT vs. LCRT: 0.7% vs. 16%). Hence, the optimal pattern of preoperative therapy of locally advanced rectal cancer still deserves to be explored. Previous studies have confirmed the feasibility and safety of 30Gy/5 fractions in SCRT of rectal cancer and verified that SCRT followed by mFOLFOX6 chemotherapy can improve the pCR rates. Therefore, investigators aimed to establish a dose escalation mode of SCRT (5×6Gy/7Gy/8Gy) followed by four cycles of modified FOLFOX6(mFOLFOX6) chemotherapy to test the safety and efficacy in treating locally advanced rectal cancer.

Sex

All

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

* Previously untreated, biopsy-proven stage T3-4 and/or N+，resectable rectal adenocarcinoma with the tumors near anal verge within 12 cm;
* Male or non-pregnant female;
* Between 18 and 70 years of age;
* Adequate hematologic function: white blood cell(WBC) counts≥4,000/mm3, neutrophils counts ≥ 1,500/mm3, platelet counts ≥ 100,000/µL, hemoglobin ≥ 9g/L;
* Adequate renal function: creatinine ≤ 1.5×upper normal limit;
* Adequate hepatic function: total bilirubin, glutamic oxalacetic transaminase, glutamate pyruvate transaminase level \< 2.0×upper normal limit);
* Satisfactory performance status: Karnofsky Performance Status(KPS)≥70;
* Approval from the ethics committee and prior written informed consents from all patients before registration were obtained.

Exclusion Criteria:

* the evidence of relapse or distant metastasis;
* receiving treatment of other anti-cancer drugs or methods;
* Patients have low compliance and are not able to complete the entire trial;
* the presence of uncontrolled life-threatening diseases;
* dysfunction of heart, brain, lung and et al.

• DERIVEDZhang MX, Li XB, Guan BJ, Guan GX, Lin XY, Wu XD, Chi P, Xu BH. Dose escalation of preoperative short-course radiotherapy followed by neoadjuvant chemotherapy in locally advanced rectal cancer: protocol for an open-label, single-centre, phase I clinical trial. BMJ Open. 2019 Mar 23;9(3):e025944. doi: 10.1136/bmjopen-2018-025944. PMID 30904869