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Concurrent Chemo-Radiotherapy Versus Radiotherapy With Boost in Locally Advanced Unresectable Rectal Cancers

Primary Purpose

Rectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Chemoradiation

Additional Radiation boost to the primary tumor volume

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Unresectable rectal cancers

Eligibility Criteria

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

Inclusion Criteria:

Patients with measurable disease, medically able to undergo pelvic surgery.
Patients with unresectable adenocarcinoma of the rectum located up to 12 cm from the anal verge without evidence of distant metastases.
Patients must be 18 years old or greater.
Patients with clinical stage T3 orT4 based on endorectal ultrasound or physical exam.
Patients with lab values within standard protocol parameters
Karnofsky performance status > 60.
No history of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix or ductal carcinoma of the breast. Previous invasive cancer permitted if disease-free at least 5 years
Patient must sign study-specific consent prior to randomization.

Exclusion Criteria:

Any evidence of distant metastasis
Synchronous primary colon carcinomas, except T1 lesions
Prior radiation therapy to the pelvis
Prior chemotherapy for malignancies
Pregnancy or lactation.
Serious, uncontrolled, concurrent infection(s).
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
Evidence of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
Major surgery within 4 weeks of the study treatment.
Lack of physical integrity of the upper gastrointestinal tract or mal-absorption syndrome.

Sites / Locations

Tata Memorial Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Arm 2 (Radiation + boost )

Arm 1 (standard) Chemoradiation

Arm Description

Radiation dose to pelvis will be delivered at 1.8 Gy per day, five days per week, to give a total of 25 fractions over a period of five weeks for a total of 45 Gy. Boost Field - Will be given to all the patients in the radiotherapy alone followed by surgery arm. The boost will be given with by 3dimensional conformal radiotherapy to a dose of 15-20 Gy. After 45Gy the boost will be planned on the original tumor volume.

The Radiation dose will be delivered at 1.8 Gy per day, five days per week, to give a total of 25 fractions over a period of five weeks for a total of 45 Gy. Chemotherapy will begin on the first day of radiotherapy and continue until the completion of radiotherapy. Capecitabine will be administered orally daily 2000 mg/m2 in two divided doses (approximately 12 hours apart) for 2 weeks followed by a 1-week rest period given as 3 week cycles.

Outcomes

Primary Outcome Measures

Comparison of resectability rate of in the two groups at 6-8 weeks following radiotherapy.

Side effects and other adverse effects in the two groups during radiotherapy and up to 2 years post radiotherapy.

Secondary Outcome Measures

Comparison of pathological downstaging between the two groups who undergo surgery.

Full Information

NCT ID

NCT00808379

First Posted

December 12, 2008

Last Updated

December 12, 2008

Sponsor

Tata Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00808379

Brief Title

Concurrent Chemo-Radiotherapy Versus Radiotherapy With Boost in Locally Advanced Unresectable Rectal Cancers

Official Title

Concurrent Chemo-Radiotherapy vs Radiotherapy With Boost in Locally Advanced Unresectable Rectal Cancers. A Randomized Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Unknown status

Study Start Date

May 2006 (undefined)

Primary Completion Date

February 2009 (Anticipated)

Study Completion Date

July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Tata Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

At Tata Memorial Hospital 50% of the patients present in the locally advanced stage which is technically unresectable, or that is beyond the realm of a potentially curative surgical resection. The evaluation of treatment approaches for these tumors is hampered by the absence of any substantial randomized studies and the heterogeneous nature of the tumors at presentation. The management of these tumors has changed over the years, there is emphasis on neoadjuvant chemoradiation therapy, trying to convert a tumor that is initially unresectable to one that is potentially curable by surgery. But only 70-80% of the patients are able to complete this treatment without any significant treatment breaks. Dose escalated treatment with radiotherapy in locally advanced and unresectable rectal cancers have been tried in many small series with good results and lesser toxicity. Comparison outcome between the two arms will indicate the relative efficacy and toxicity of neoadjuvant concurrent chemoradiation vs boosted radiotherapy alone in downstaging of advanced cancers.

Detailed Description

Aims/ Objectives To compare the resectability rate when patients are treated when conventional chemoradiation to patients treated with radiation alone with an additional boost to the primary tumor in case of unresectable rectal cancers. To study the treatment toxicity and local control rate. Study methodology This is a phase II Randomised controlled study. Ninety cases of advanced rectal cancer (Stage II - Stage III) will be divided in two equal groups (Arm I & II) Arm-1(standard arm) - Patients will receive standard external radiation therapy to pelvis + concurrent chemotherapy with Tab Capecitabine. This will be followed by surgery at 6-8 weeks if deemed resectable. Arm-2 (research arm) Patients in this group will not receive any neo-adjuvant chemotherapy, instead they will receive radiotherapy alone additional dose of localized radiotherapy boost. This will be followed by surgery at 6-8 weeks if deemed resectable.

6. Conditions and Keywords

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

Rectal Cancer

Keywords

Unresectable rectal cancers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 2 (Radiation + boost )

Arm Type

Other

Arm Description

Arm Title

Arm 1 (standard) Chemoradiation

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Chemoradiation

Other Intervention Name(s)

Capebine

Intervention Description

Chemotherapy will begin on the first day of radiotherapy and continue until the completion of radiotherapy. Capecitabine will be administered orally daily 2000 mg/m2 in two divided doses (approximately 12 hours apart) for 2 weeks followed by a 1-week rest period given as 3 week cycles.

Intervention Type

Radiation

Intervention Name(s)

Additional Radiation boost to the primary tumor volume

Other Intervention Name(s)

Radiation Boost

Intervention Description

15-20Gy

Primary Outcome Measure Information:

Title

Comparison of resectability rate of in the two groups at 6-8 weeks following radiotherapy.

Time Frame

3 years

Title

Side effects and other adverse effects in the two groups during radiotherapy and up to 2 years post radiotherapy.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Comparison of pathological downstaging between the two groups who undergo surgery.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with measurable disease, medically able to undergo pelvic surgery. Patients with unresectable adenocarcinoma of the rectum located up to 12 cm from the anal verge without evidence of distant metastases. Patients must be 18 years old or greater. Patients with clinical stage T3 orT4 based on endorectal ultrasound or physical exam. Patients with lab values within standard protocol parameters Karnofsky performance status > 60. No history of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix or ductal carcinoma of the breast. Previous invasive cancer permitted if disease-free at least 5 years Patient must sign study-specific consent prior to randomization. Exclusion Criteria: Any evidence of distant metastasis Synchronous primary colon carcinomas, except T1 lesions Prior radiation therapy to the pelvis Prior chemotherapy for malignancies Pregnancy or lactation. Serious, uncontrolled, concurrent infection(s). Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months. Evidence of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation. Major surgery within 4 weeks of the study treatment. Lack of physical integrity of the upper gastrointestinal tract or mal-absorption syndrome.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reena Engineer, MD

Organizational Affiliation

Tata Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tata Memorial Centre

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400012

Country

India

12. IPD Sharing Statement

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Concurrent Chemo-Radiotherapy Versus Radiotherapy With Boost in Locally Advanced Unresectable Rectal Cancers

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