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Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer. (INCAGI004)

Primary Purpose

Rectal Neoplasm Malignant

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Capecitabine Oral Product

5Fluorouracil

About this trial

This is an interventional treatment trial for Rectal Neoplasm Malignant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with histologically proven locally advanced rectal cancer (cT3-4 or positive regional lymph node) on endorectal ultrasonography (EUS) or pelvic Magnetic Resonance Imaging (MRI) were qualified for this study. Distance from anal verge (AV) should not exceed 10 cm measured with rigid proctoscopy. Thorax and abdominal computer tomography (CT) exams were taken to rule out distant metastasis. Performance Status ECOG 0-1.

Exclusion Criteria:

Previous treatment for rectal cancer (RT, chemotherapy or surgical resection). Previous diagnosis of other cancers except nonmelanoma skin cancer. Uncontrolled comorbities including heart failure and miocardial infarction in the previous 6 months. Hepatic insufficiency and renal failure. Pregnancy. Serious neurologic or psyquiatric disturbances that could affect comprehension of informed consent.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Capecitabine

5-Flourouracil

Arm Description

Neoadjuvant capecitabine plus RT

Neoadjuvant 5-Fluorouracil plus RT

Outcomes

Primary Outcome Measures

Clinical downstaging

Clinical downstaging after neoadjuvant treatment

Secondary Outcome Measures

Pathological downstaging

Patholgical downstaging after neoadjuvant treatment

Full Information

NCT ID

NCT03428529

First Posted

February 5, 2018

Last Updated

February 5, 2018

Sponsor

Instituto Nacional de Cancer, Brazil

1. Study Identification

Unique Protocol Identification Number

NCT03428529

Brief Title

Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.

Acronym

INCAGI004

Official Title

Estudo Randomizado de Fase II Com Capecitabina Versus 5-Fluorouracil/Leucovorin em Bolus Associados à Radioterapia no Tratamento Neoadjuvante de câncer de Reto Localmente avançado: INCAGI004.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 12, 2011 (Actual)

Primary Completion Date

October 13, 2016 (Actual)

Study Completion Date

December 13, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Nacional de Cancer, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A randomized two-arm study comparing preoperative CRT using oral capecitabine versus bolus 5-FU/LV concomitant to external beam radiation (50.5 Gy/28 fractions) for locally advanced rectal cancer. Main outcome was clinical response assessed using MRI and endorectal US 6-8 weeks after CRT. Secondary endpoints were pathological response, adverse effects, sphyncter preservation, quality of life, OS and DFS.

Detailed Description

Patients harbouring rectal adenocarcinoma T3-4 or N>0 M0 within 10 cm to anal verge were randomized in two treatment arms: (1) capecitabina orally 825mg/m2 bid. 5 days a week for 5 weeks and (2) bolus intravenous 5-FU/LV 350mg/m2/20 mg/m2 D1-D5 on the first and fifth weeks, both combined to pelvic radiotherapy, total dose 50.4 Gy in 28 fractions. Clinical stage before and after CRT was determined using pelvic Magnetic Resonance Imaging (MRI), endorectal ultrasonography (ERUS) and chest, abdominal and pelvic Computer Tomography. Surgery was planned 6 to 8 weeks after CRT. Sphincter preservation was always considered when negative margins were possible. Pathological assessment included stage (TNM 7th Ed.) and Mandard's Tumor Regression Grade (TRG). QOL questionnaires QLQ-C30 and CR38 were completed by patients before and after CRT, after surgery and during follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Neoplasm Malignant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

1:1 randomization

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine

Arm Type

Experimental

Arm Description

Neoadjuvant capecitabine plus RT

Arm Title

5-Flourouracil

Arm Type

Active Comparator

Arm Description

Neoadjuvant 5-Fluorouracil plus RT

Intervention Type

Drug

Intervention Name(s)

Capecitabine Oral Product

Other Intervention Name(s)

Xeloda

Intervention Description

Neoadjuvant Capecitabine concomitant to external beam radiotherapy

Intervention Type

Drug

Intervention Name(s)

5Fluorouracil

Other Intervention Name(s)

5-Fu

Intervention Description

Neoadjuvant bolus 5-Fluorouracil concomitante to external beam radiotherapy

Primary Outcome Measure Information:

Title

Clinical downstaging

Description

Clinical downstaging after neoadjuvant treatment

Time Frame

6-8 weeks after CRT

Secondary Outcome Measure Information:

Title

Pathological downstaging

Description

Patholgical downstaging after neoadjuvant treatment

Time Frame

8 weeks after CRT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with histologically proven locally advanced rectal cancer (cT3-4 or positive regional lymph node) on endorectal ultrasonography (EUS) or pelvic Magnetic Resonance Imaging (MRI) were qualified for this study. Distance from anal verge (AV) should not exceed 10 cm measured with rigid proctoscopy. Thorax and abdominal computer tomography (CT) exams were taken to rule out distant metastasis. Performance Status ECOG 0-1. Exclusion Criteria: Previous treatment for rectal cancer (RT, chemotherapy or surgical resection). Previous diagnosis of other cancers except nonmelanoma skin cancer. Uncontrolled comorbities including heart failure and miocardial infarction in the previous 6 months. Hepatic insufficiency and renal failure. Pregnancy. Serious neurologic or psyquiatric disturbances that could affect comprehension of informed consent. -

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD could be shared if requested after IRB approval.

Citations:

PubMed Identifier

17909820

Citation

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Results Reference

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Citation

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Results Reference

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Citation

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Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.

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