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

NCT02000050 | Completed Phase 2

• 2 other identifiers: IRST154.012013-000770-30
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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. 1.Neoadjuvant Treatment (pre-operative chemo-radiotherapy regimen):
2. 2.Restaging (week 11)
3. 3.Surgery (week 12-16) with Total Mesorectal Excision (TME)
4. 4.End Of Treatment (week 16-32)
5. 5.Adjuvant therapy (The maximum interval between surgery and start of adjuvant therapy should be 8 weeks):
6. 6.FOLFOX4\* 8 cycles (every 2 weeks)

Conditions

Rectal Carcinoma

Keywords

resectable rectal cancer; up-front chemotherapy; neo-adjuvant short course radiotherapy; short course radiotherapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  3 years

Secondary Outcomes (5)

• Objective tumor response rate (ORR)

  5 years

• Pathological Downstaging Rate

  5 years

• Disease-free survival time (DFS)

  5 years

• Overall survival time (OS)

  5 years

• Intention-to-treat (ITT) population

  5 years

Study Arms (1)

Single Arm

EXPERIMENTAL

* Neoadjuvant therapy: FOLFOX4 2 cycles + Tomotherapy + FOLFOX4 2 cycles * Surgery * Adjuvant therapy: FOLFOX4 8 cycles * TME (Total Mesorectal Excision)

Drug: FOLFOX4; Radiation: Tomotherapy; Procedure: TME (Total Mesorectal Excision)

Interventions

FOLFOX4 DRUG

FOLFOX4

Single Arm

Tomotherapy RADIATION

Tomotherapy

Single Arm

TME (Total Mesorectal Excision) PROCEDURE

TME (Total Mesorectal Excision)

Also known as: surgery

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

UO Oncologia Medica IRCCS IRST

Meldola, FC, 47014, Italy

Location

Oncologia Medica PO RAVENNA; FAENZA; LUGO

Ravenna, RA, 48121, Italy

Location

Related Publications (1)

• 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.

  PMID: 33343722 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Folfox protocol; Radiotherapy, Intensity-Modulated; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Alessandro Passardi, MD

  IRST IRCCS, Meldola

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: October 11, 2013
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

IT (2)