Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-28 @ 11:33 AM
Study NCT ID:
NCT02000050
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Up-front Chemotherapy and Neo-adjuvant Short-course Radiotherapy for Resectable Rectal Carcinoma (COLORE)
Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Organization:
Study Overview
Official Title:
Phase II Study of Up-front Chemotherapy and Neo-adjuvant Short-course Radiotherapy for Resectable Rectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLORE
Brief 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.
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.
Detailed Description:
Title: Phase II study of up-front chemotherapy and neo-adjuvant shortcourse radiotherapy for resectable rectal carcinoma.
Short Title/Acronym: COLORE
Protocol Code: IRST154.01
Phase: 2
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.
OBJECTIVES
Primary objectives:
Step A: to evaluate the feasibility and safety of the chemoradiotherapy regimen.
Step B: to evaluate the proportion of patients with pathological complete remission after combined radio-chemotherapy.
Secondary objectives (of Step B):
* To evaluate the safety of the neo-adjuvant treatment
* To determine pathological down-staging
* To evaluate the rate of R0 resection
* To evaluate the sphincter saving resection rate
* To evaluate median disease free survival and overall survival
* To evaluate the correlation between biomarker, pathological response and outcome (auxiliary\\subsidiary Biological Study)
NUMBER OF SUBJECT:
· 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.
STATISTICAL METHODOLOGY:
The primary analysis will be performed on the ITT (Intention-To-Treat) population, while the secondary analysis will be conducted on the PP (Per Protocol) population.
The number and percentage of treated patients undergoing grade 1 to 4 adverse events (CTC-AE, version 4.0) will be tabulated in the ITT and PP population. No statistical inference will be performed.
Step A: Patients, tumor characteristics and toxicity events observed will be described.
Step B: The proportion of patients with pathological Complete Response will be calculated. Safety profile will be analyzed. OS (Overall Survival) and DFS (Disease Free Survival) will be estimated with Kaplan-Meier method (Kaplan El, Meier P., J Am Stat Assoc 1958).
No interim analysis will be performed. The 95% confidence intervals should also be provided.
Short Title/Acronym: COLORE
Protocol Code: IRST154.01
Phase: 2
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.
OBJECTIVES
Primary objectives:
Step A: to evaluate the feasibility and safety of the chemoradiotherapy regimen.
Step B: to evaluate the proportion of patients with pathological complete remission after combined radio-chemotherapy.
Secondary objectives (of Step B):
* To evaluate the safety of the neo-adjuvant treatment
* To determine pathological down-staging
* To evaluate the rate of R0 resection
* To evaluate the sphincter saving resection rate
* To evaluate median disease free survival and overall survival
* To evaluate the correlation between biomarker, pathological response and outcome (auxiliary\\subsidiary Biological Study)
NUMBER OF SUBJECT:
· 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.
STATISTICAL METHODOLOGY:
The primary analysis will be performed on the ITT (Intention-To-Treat) population, while the secondary analysis will be conducted on the PP (Per Protocol) population.
The number and percentage of treated patients undergoing grade 1 to 4 adverse events (CTC-AE, version 4.0) will be tabulated in the ITT and PP population. No statistical inference will be performed.
Step A: Patients, tumor characteristics and toxicity events observed will be described.
Step B: The proportion of patients with pathological Complete Response will be calculated. Safety profile will be analyzed. OS (Overall Survival) and DFS (Disease Free Survival) will be estimated with Kaplan-Meier method (Kaplan El, Meier P., J Am Stat Assoc 1958).
No interim analysis will be performed. The 95% confidence intervals should also be provided.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-000770-30 | EUDRACT_NUMBER | None | View |