Phase II Study of Up-front Chemotherapy and Neo-adjuvant Short-course Radiotherapy for Resectable Rectal Carcinoma (COLORE)

Summary

Phase II study of up-front chemotherapy and neo-adjuvant shortcourse radiotherapy for resectable rectal carcinoma. Study Design: Phase II, open-label, single-arm, multi-centre study. STUDY PRODUCT,DOSE,ROUTE,REGIMEN AND DURATION OF ADMINISTRATION: 1. Neoadjuvant Treatment (pre-operative chemo-radiotherapy regimen): FOLFOX4\* 2 cycles (WK1+WK3) - Tomotherapy\*\* (WK5) - FOLFOX4\* 2 cycles (WK7+WK9) \* Oxaliplatin 85 mg/m2 iv: day 1 Levofolinate 100 mg/m2 iv: day 1-2 5-fluorouracil 400 mg/m2 iv in bolus and 600 mg/m2 iv infusion over 22h: day 1-2 Every cycle will last 2 weeks (approximately 48 hours of treatment infusion and 12 days of rest). \*\* 25 Gy in 5 consecutive fractions, one fraction per day in 5 days on CTV (Clinical Target Volume) at the isodose of the 95% of the total dose. The treatment plan will be elaborated at the work-station dedicated to the Helicoidal Tomotherapy. The treatment could be planned also with linear accelerator with IGRT-IMRT technique or VMAT technique. 2. Restaging (week 11) 3. Surgery (week 12-16) with Total Mesorectal Excision (TME) 4. End Of Treatment (week 16-32) 5. Adjuvant therapy (The maximum interval between surgery and start of adjuvant therapy should be 8 weeks): 6. FOLFOX4\* 8 cycles (every 2 weeks) Study Duration: about 5 years. Enrollment period: 36 months. Treatment period: about 8 months. Follow-up: 1 year. NUMBER OF SUBJECTs: · Step A: a maximum of 6 patients. 6 evaluable patients are needed to assess toxicity. If 1 toxicity resulting in discontinuation of treatment will be observed in 6 patients, the treatment can be considered safe (with a confidence \> 90%). If 2 or more toxicity resulting in discontinuation of treatment on 6 patients, the study will be stopped because not safe and another type of radiotherapy schedule must be designed. · Step B: a total of 50 patients is required to be recruited in 2 years (including patients enrolled in Step A). The goal is to achieve a proportion of at least 15% of patients with a complete pathological response with the new radiochemotherapeutic treatment.

Timeline

Start

2013-10-11

Primary completion

2019-03-15

Completion

2019-03-15

Publications

• Results Passardi A, Rapposelli IG, Scarpi E, Neri E, Parisi E, Ghigi G, Ercolani G, Avanzolini A, Cavaliere D, Rudnas B, Valgiusti M, Barone D, Ferroni F, Frassineti GL, Romeo A. Neoadjuvant treatment (FOLFOX4 plus hypofractionated tomotherapy) for patients with locally advanced rectal cancer: a multicenter phase II trial. Ther Adv Med Oncol. 2020 Dec 8;12:1758835920977139. doi: 10.1177/1758835920977139. eCollection 2020.

Drugs

Indications