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Induction Chemotherapy,Radiochemotherapy, Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer

Primary Purpose

Rectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

Slovenia

Study Type

Interventional

Intervention

intensified preoperative chemotherapy

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, capecitabine, radiotherapy, locally advanced rectal cancer

Eligibility Criteria

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

Inclusion Criteria:

Male or female patients with histologically proven adenocarcinoma of the rectum (tumour located below the peritoneum),
T3/4 or any node positive disease (clinical stage according the TNM classification system)
No evidence of metastatic disease.
The disease must be considered either resectable at the time of entry or thought to become resectable after preoperative chemoradiation.
Age 18 years and more
WHO Performance Status 0-2
No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
Adequate hematological, hepatic and renal function Ability to swallow tablets
Signed informed consent
Patients must be willing and able to comply with the protocol for duration of the study

Exclusion Criteria:

Malignancy of the rectum other than adenocarcinoma
Any unrested synchronous colon cancer
Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
Significant heart disease (uncontrolled hypertension despite of medication (> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
Pregnant or lactating patient
Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)

Sites / Locations

Institute of OncologyRecruiting

Outcomes

Primary Outcome Measures

Pathological complete remission rate (pCR)

Secondary Outcome Measures

Toxicity

Number of patients with adverse events and the grade of adverse events

Histopathological R0 resection rate

Loco-regional failure rate

Disease-free survival

Overall survival

Quality of life

We will use EORTC questionnaires QLQ C30 and C38

Full Information

NCT ID

NCT01489332

First Posted

November 11, 2011

Last Updated

December 7, 2011

Sponsor

Institute of Oncology Ljubljana

1. Study Identification

Unique Protocol Identification Number

NCT01489332

Brief Title

Induction Chemotherapy,Radiochemotherapy, Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer

Official Title

Induction Chemotherapy, Preoperative Radiochemotherapy, Consolidation Chemotherapy, Operation and Adjuvant Chemotherapy in the Treatment of Locally Advanced Rectal Cancer- OIGIT 5-01 Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2011 (undefined)

Primary Completion Date

April 2013 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Oncology Ljubljana

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is standard treatment of locally advanced rectal cancer. It has reduced local recurrence rate to less than 10%, but has only had limited effect on overall survival due to the constantly high (more than 30%) rate of distant metastasis. Complete eradication of the primary tumour observed in the histopathological specimen (pathological complete response, pCR) correlates with a favourable overall prognosis so obtaining a pCR might be beneficial. The aim of the study is to investigate whether the addition of capecitabine based chemotherapy before preoperative chemoradiation and also before the operation improves pathological complete remission rate in locally advanced rectal cancer with acceptable toxicity. Secondary objectives are to evaluate pathological downstaging rate, histopathological R0 resection rate,sphincter preservation rate, perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality of life.

6. Conditions and Keywords

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

Rectal Cancer

Keywords

rectal cancer, capecitabine, radiotherapy, locally advanced rectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

intensified preoperative chemotherapy

Intervention Description

capecitabine 1250 mg/m² p.o. twice daily for 14 consecutive days, 7 days rest for one cycle; radiotherapy: 50.4 Gy to the pelvis (25x 1.8 Gy on days 1-33, excluding weekends) plus 5.4 Gy on days 36-38 as a boost to the primary tumour (3 fractions of 1.8 Gy).Three- dimensional CT planing and a four field box technique with high energy photons (15 MV) will be used. capecitabine 825 mg/m² p.o. twice daily on days 1-38 (including weekends), One week after completion of radiochemotherapy patients receive 2 cycles of capecitabine based chemotherapy (1250 mg/m² p.o. twice daily for 14 consecutive days every three weeks). Radical surgery (TME): to be undertaken 8 weeks following completion of chemoradiation Postoperative treatment:capecitabine 1250 mg/m² p.o. twice daily for 14 consecutive days every three weeks; 3 cycles (R0 beginning 6-8 weeks after surgery

Primary Outcome Measure Information:

Title

Pathological complete remission rate (pCR)

Time Frame

after the pathological examination of surgical speciments ie within 14 days after the operation

Secondary Outcome Measure Information:

Title

Toxicity

Description

Number of patients with adverse events and the grade of adverse events

Time Frame

According to NCI-CTC (version 3.0): every week for 16 week preoperative, perioperative (0-30 days postoperative), early (30 days - 6 months postoperative), and late (more than 6 months postoperative)

Title

Histopathological R0 resection rate

Time Frame

after the pathological examination of resected speciments ie within 14 days after the operation

Title

Loco-regional failure rate

Time Frame

after 3y and 5y of operation

Title

Disease-free survival

Time Frame

after 3y and 5y of operation

Title

Overall survival

Time Frame

after 3y and 5y of the operation

Title

Quality of life

Description

We will use EORTC questionnaires QLQ C30 and C38

Time Frame

before the treatment, after 1,and 3 years of the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients with histologically proven adenocarcinoma of the rectum (tumour located below the peritoneum), T3/4 or any node positive disease (clinical stage according the TNM classification system) No evidence of metastatic disease. The disease must be considered either resectable at the time of entry or thought to become resectable after preoperative chemoradiation. Age 18 years and more WHO Performance Status 0-2 No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer Adequate hematological, hepatic and renal function Ability to swallow tablets Signed informed consent Patients must be willing and able to comply with the protocol for duration of the study Exclusion Criteria: Malignancy of the rectum other than adenocarcinoma Any unrested synchronous colon cancer Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin Significant heart disease (uncontrolled hypertension despite of medication (> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment) Pregnant or lactating patient Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vaneja Velenik, Prof.assist

Phone

+386 1 5879297

vvelenik@onko-i.si

First Name & Middle Initial & Last Name or Official Title & Degree

Franc Anderluh, MD

Phone

+386 1 5879297

fanderluh@onko/i.si

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vaneja Velenik, Prof.assist

Organizational Affiliation

Institute of Oncology Ljubljana, Slovenia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Oncology

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vaneja Velenik, Prof.assist

Phone

+386 1 5879297

vvelenik@onko/i.si

First Name & Middle Initial & Last Name & Degree

Franc Anderluh, MD

Phone

+386 1 5879297

fanderluh@onko/i.si

First Name & Middle Initial & Last Name & Degree

Vaneja Velenik, Prof.assist

First Name & Middle Initial & Last Name & Degree

Irena Oblak, Prof.assist

First Name & Middle Initial & Last Name & Degree

Franc Anderluh, MD

First Name & Middle Initial & Last Name & Degree

Marija Skoblar Vidmar, MD

First Name & Middle Initial & Last Name & Degree

Ajra Secerov Ermenc, MD

First Name & Middle Initial & Last Name & Degree

Danijela Golo, MD

First Name & Middle Initial & Last Name & Degree

Ibrahim Edhemovic, MD

First Name & Middle Initial & Last Name & Degree

Erik Brecelj, PhD, MD

First Name & Middle Initial & Last Name & Degree

Mirko Omejc, Prof

First Name & Middle Initial & Last Name & Degree

Bojan Krebs, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

15383798

Citation

Habr-Gama A, Perez RO, Nadalin W, Sabbaga J, Ribeiro U Jr, Silva e Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results. Ann Surg. 2004 Oct;240(4):711-7; discussion 717-8. doi: 10.1097/01.sla.0000141194.27992.32.

Results Reference

background

PubMed Identifier

20920276

Citation

Velenik V, Oblak I, Anderluh F. Long-term results from a randomized phase II trial of neoadjuvant combined-modality therapy for locally advanced rectal cancer. Radiat Oncol. 2010 Sep 29;5:88. doi: 10.1186/1748-717X-5-88.

Results Reference

background

PubMed Identifier

12131088

Citation

Ruo L, Tickoo S, Klimstra DS, Minsky BD, Saltz L, Mazumdar M, Paty PB, Wong WD, Larson SM, Cohen AM, Guillem JG. Long-term prognostic significance of extent of rectal cancer response to preoperative radiation and chemotherapy. Ann Surg. 2002 Jul;236(1):75-81. doi: 10.1097/00000658-200207000-00012.

Results Reference

background

PubMed Identifier

21098619

Citation

Bujko K, Glynne-Jones R, Bujko M. Adjuvant chemotherapy for rectal cancer. Ann Oncol. 2010 Dec;21(12):2443. doi: 10.1093/annonc/mdq616. No abstract available.

Results Reference

background

PubMed Identifier

20231300

Citation

Bujko K, Glynne-Jones R, Bujko M. Does adjuvant fluoropyrimidine-based chemotherapy provide a benefit for patients with resected rectal cancer who have already received neoadjuvant radiochemotherapy? A systematic review of randomised trials. Ann Oncol. 2010 Sep;21(9):1743-1750. doi: 10.1093/annonc/mdq054. Epub 2010 Mar 15.

Results Reference

background

PubMed Identifier

19934911

Citation

Habr-Gama A, Perez RO, Sabbaga J, Nadalin W, Sao Juliao GP, Gama-Rodrigues J. Increasing the rates of complete response to neoadjuvant chemoradiotherapy for distal rectal cancer: results of a prospective study using additional chemotherapy during the resting period. Dis Colon Rectum. 2009 Dec;52(12):1927-34. doi: 10.1007/DCR.0b013e3181ba14ed.

Results Reference

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Induction Chemotherapy,Radiochemotherapy, Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer

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