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

NCT02000050 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-01-30

No results posted yet for this study

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.

Conditions

  • Rectal Carcinoma

Interventions

DRUG

FOLFOX4

FOLFOX4

RADIATION

Tomotherapy

Tomotherapy

PROCEDURE

TME (Total Mesorectal Excision)

TME (Total Mesorectal Excision)

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Alessandro Passardi, MD · IRST IRCCS, Meldola

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-11
Primary Completion
2019-03-15
Completion
2019-03-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000050 on ClinicalTrials.gov