Rectal CarcinomaPhase 2COLORENCT02000050

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

A Phase 2 study testing FOLFOX4, Tomotherapy and TME (Total Mesorectal Excision) in people with Rectal Carcinoma, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Rectal Carcinoma
What is being tested?: FOLFOX4, Tomotherapy and TME (Total Mesorectal Excision)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 2 sitesItaly
Study dates: 11 Oct 2013to 15 Mar 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with histologically or cytologically confirmed diagnosis of adenocarcinoma of the mid-low rectum (within 12 cm from the anal verge)
Stage: lowT2N0, T2N+M0, T3-4 N-/+M0 (N+ = ≥ 3 nodes >0,5 cm diameter or ≥ 1 nodes > 1 cm diameter)
Age ≥18 and ≤ 80 years
ECOG performance status 0-1
Patients must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3,000/mL

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- Absolute neutrophil count ≥ 1,500/mL
- Platelets ≥ 100,000/mL
- Total bilirubin ≤ 1.5 X ULN
- AST (SGOT)/ALT (SGPT) ≤ 2.5 X ULN
- Creatinine ≤ 1.5 X ULN
Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
Participant is willing and able to give informed consent for participation in the study.

Who cannot join

Metastatic disease
Patients who have had any chemotherapy or radiotherapy prior to entering the study
Acute or sub-acute gastrointestinal occlusion
Participation in another clinical trial, with any investigational agent within 30 days prior the study screening
Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma, superficial bladder tumor and in situ carcinoma of the uterine cervix)
History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study
Uncontrolled concomitant illness, including but not limited to: ongoing or active infections; congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance to study requirements

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

UO Oncologia Medica IRCCS IRST
Meldola, FC, 47014
Oncologia Medica PO RAVENNA; FAENZA; LUGO
Ravenna, RA, 48121

Other trials in Italy

About this study

Official title: Phase II Study of Up-front Chemotherapy and Neo-adjuvant Short-course Radiotherapy for Resectable Rectal Carcinoma

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:

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.

Restaging (week 11)
Surgery (week 12-16) with Total Mesorectal Excision (TME)
End Of Treatment (week 16-32)
Adjuvant therapy (The maximum interval between surgery and start of adjuvant therapy should be 8 weeks):
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.

Read the 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:

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.

Restaging (week 11)
Surgery (week 12-16) with Total Mesorectal Excision (TME)
End Of Treatment (week 16-32)
Adjuvant therapy (The maximum interval between surgery and start of adjuvant therapy should be 8 weeks):
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.

Conditions: Rectal Carcinoma
Being tested: FOLFOX4, Tomotherapy, TME (Total Mesorectal Excision)
Keywords: resectable rectal cancer, up-front chemotherapy, neo-adjuvant short course radiotherapy, short course radiotherapy
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FOLFOX4Drug
FOLFOX4
TomotherapyRadiation
Tomotherapy
TME (Total Mesorectal Excision)Procedure or surgery
Also called surgery
TME (Total Mesorectal Excision)

Study groups in NCT02000050
Study group	Role	What they receive
Single Arm	Experimental	* Neoadjuvant therapy: FOLFOX4 2 cycles + Tomotherapy + FOLFOX4 2 cycles * Surgery * Adjuvant therapy: FOLFOX4 8 cycles * TME (Total Mesorectal Excision) Receives: Drug: FOLFOX4; Radiation: Tomotherapy; Procedure: TME (Total Mesorectal Excision)

What is being measured

The primary outcome is the main question the study is designed to answer.

Toxicity events
6 evaluable patients are needed to assess toxicity. If one toxicity resulting in discontinuation of treatment will be observed in 6 patients, we can conclude that the true probability of toxicity is less than 45% with a confidence >90% and the treatment can be considered safe. If 2 or more toxicity resulting in discontinuation of treatment on 6 patients we can conclude that the true probability of toxicity is greater than 10% with a confidence >90%, and the study will be stopped because not safe and another type of radiotherapy schedule must be designed.
Measured: 15 months
The Simon optimal two-stage design (Richard Simon, Controlled Clinical Trials 1989)
It's a two-stage design that use for P1(the proportion of pCR with the new radio-chemotherapeutic treatment) - P0 (the expected proportion of pCR) =0.15. It's used to understand if a treatment is active or not.
Measured: 15 months
Complete pathological response (pCR)
According to pathological response criteria, a total regression is considered a complete response. This parameter is used to understand if a treatment is active or not ( if at least 7 patients out of 50 enrolled will achieve a pCR, the treatment could be considered active).
Measured: 3 years

Secondary outcomes (5)

Objective tumor response rate (ORR)
It is the proportion of the intention-to-treat (ITT) population showing a complete or partial response, if confirmed ≥ 4 weeks later.
It will be assessed using RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Measured: 5 years
Pathological Downstaging Rate
The proportion of subjects with an improved histopathological response by one or more grade relative to baseline following rectal surgery with Total Mesorectal Excision (TME).
Measured: 5 years
Disease-free survival time (DFS)
The time from enrolment date to date of first observed progression, relapse or death.
Measured: 5 years
Overall survival time (OS)
Time from enrolment to the date of death.
Measured: 5 years
Intention-to-treat (ITT) population
The population of all enrolled patients with baseline assessment of disease, receiving 2 cycles of treatment of FOLFOX4 and at least 1 day of radiotherapy.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 201315 Mar 2019

First posted3 Dec 2013 (estimated)
Study start11 Oct 2013
Primary completion15 Mar 2019
Study completion15 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rectal CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02000050
Sponsor's protocol ID: IRST154.01
Other IDs: 2013-000770-30
Acronym: COLORE
Status last verified: Jan 2025
First submitted: 26 Nov 2013
Last updated: 30 Jan 2025
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 33343722

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rectal Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Up-front Chemotherapy and Neo-adjuvant Short-course Radiotherapy for Resectable Rectal Carcinoma
ClinicalTrials.gov ID: NCT02000050
Acronym / sponsor ID: COLORE / IRST154.01
Conditions: Rectal Carcinoma
Keywords: resectable rectal cancer, up-front chemotherapy, neo-adjuvant short course radiotherapy, short course radiotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
Study start: 11 Oct 2013 (actual)
Primary completion: 15 Mar 2019 (actual)
Study completion: 15 Mar 2019 (actual)
First posted: 3 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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.

Restaging (week 11)
Surgery (week 12-16) with Total Mesorectal Excision (TME)
End Of Treatment (week 16-32)
Adjuvant therapy (The maximum interval between surgery and start of adjuvant therapy should be 8 weeks):
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:

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.

Restaging (week 11)
Surgery (week 12-16) with Total Mesorectal Excision (TME)
End Of Treatment (week 16-32)
Adjuvant therapy (The maximum interval between surgery and start of adjuvant therapy should be 8 weeks):
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.

No interim analysis will be performed. The 95% confidence intervals should also be provided.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Drug: FOLFOX4, Radiation: Tomotherapy, Procedure: TME (Total Mesorectal Excision)* Neoadjuvant therapy: FOLFOX4 2 cycles + Tomotherapy + FOLFOX4 2 cycles * Surgery * Adjuvant therapy: FOLFOX4 8 cycles * TME (Total Mesorectal Excision)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Patients with histologically or cytologically confirmed diagnosis of adenocarcinoma of the mid-low rectum (within 12 cm from the anal verge)
Stage: lowT2N0, T2N+M0, T3-4 N-/+M0 (N+ = ≥ 3 nodes >0,5 cm diameter or ≥ 1 nodes > 1 cm diameter)
Age ≥18 and ≤ 80 years
ECOG performance status 0-1
Patients must have normal organ and marrow function as defined below:

Key exclusion criteria (7 listed)

Metastatic disease
Patients who have had any chemotherapy or radiotherapy prior to entering the study
Acute or sub-acute gastrointestinal occlusion
Participation in another clinical trial, with any investigational agent within 30 days prior the study screening
Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma, superficial bladder tumor and in situ carcinoma of the uterine cervix)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FOLFOX4FOLFOX4	Drug	Single Arm
TomotherapyTomotherapy	Radiation	Single Arm
TME (Total Mesorectal Excision)Also: surgeryTME (Total Mesorectal Excision)	Procedure or surgery	Single Arm

Primary outcome

Toxicity events
Time frame: 15 months
6 evaluable patients are needed to assess toxicity. If one toxicity resulting in discontinuation of treatment will be observed in 6 patients, we can conclude that the true probability of toxicity is less than 45% with a confidence >90% and the treatment can be considered safe. If 2 or more toxicity resulting in discontinuation of treatment on 6 patients we can conclude that the true probability of toxicity is greater than 10% with a confidence >90%, and the study will be stopped because not safe and another type of radiotherapy schedule must be designed.
The Simon optimal two-stage design (Richard Simon, Controlled Clinical Trials 1989)
Time frame: 15 months
It's a two-stage design that use for P1(the proportion of pCR with the new radio-chemotherapeutic treatment) - P0 (the expected proportion of pCR) =0.15. It's used to understand if a treatment is active or not.
Complete pathological response (pCR)
Time frame: 3 years
According to pathological response criteria, a total regression is considered a complete response. This parameter is used to understand if a treatment is active or not ( if at least 7 patients out of 50 enrolled will achieve a pCR, the treatment could be considered active).

5 secondary outcomes

Objective tumor response rate (ORR)
Time frame: 5 years
Pathological Downstaging Rate
Time frame: 5 years
Disease-free survival time (DFS)
Time frame: 5 years
Overall survival time (OS)
Time frame: 5 years
Intention-to-treat (ITT) population
Time frame: 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
Results publication: PubMed 33343722Passardi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alessandro Passardi, MD principal investigator

IRST IRCCS, Meldola

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity events (time frame: 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02000050, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.