- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01653301
Preoperative Downstaging of Extraperitoneal T3 Rectal Cancer: XELOXRT Versus XELACRT. A Multicenter, Phase III Study (INTERACT)
INTEnsification Radiotherapy With Accelerated Fractionation or ChemoTherapy And Local Excision After 3D External Radio-chemotherapy
- INTERACT study: to evaluate the pathological response rate in cT3 rectal cancer
- LEADER study: to evaluate the impact on local control of local excision
Study Overview
Detailed Description
- INTERACT study: to evaluate the pathological response rate evaluated according to TRG scale comparing accelerated radiotherapy on the gross tumour combined plus standard radiotherapy to the pelvis in association with chronomodulated capecitabine (XELACRT arm) versus oxaliplatin added to standard pelvis radiotherapy and same chronomodulated Capecitabine (XELOXRT arm)
- LEADER study: to evaluate the impact on local control of local excision in patients who had a major clinical response evaluated by MRI and confirmed by TRG 1-2 score.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Rome, Italy, 00168
- Recruiting
- Catholic University Of Sacred Heart
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INTERACT STUDY
Inclusion Criteria:
- Histologically confirmed primary adenocarcinoma of the rectum.
- Tumour within 12 cm of the anal verge by proctoscopic examination or within 10 cm of the anorectal ring by MRI.
- Clinical stages (UICC 1997): cT2N0-2 low located tumour, cT3 N0-2.
- Resectable disease at the routine examination.
- Age > 18 years.
- Karnofsky Performance Status > 60.
- WBC > 4,000 cells/ml, platelets > 100,000 cells/ml.
- Provision of written informed consent.
Exclusion Criteria:
- Evidence of metastatic (M1) disease. If there were any suspicious findings (i.e. liver metastasis, lung nodule, retroperitoneal adenopathy, etc.) the patient is to be considered as ineligible, unless malignancy is ruled out by tissue documentation (biopsy) before trial therapy is started.
- Previous chemotherapy, immunotherapy, or radiation therapy to the pelvis.
- Multiple primary cancers involving both the colon and rectum that would preclude a patient from being classified as having only rectal cancer.
- Incomplete healing from or other surgery.
- Active inflammatory bowel disease.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- Cardiovascular disease with a New York Heart Association Functional Status > 2.
- Absolute neutrophil count (ANC) < 4 x 108/L or platelets < 50 x 108/L.
- Measured Creatinine clearance less than 65ml/min. (no drug dose reduction for lower GFR is allowed).
- ALT or AST > 2.5 times the ULRR
- Pregnancy or breastfeeding (women of child-bearing potential).
- Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- Any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
LEADER STUDY
Inclusion Criteria
- Stage at the diagnosis: cT3N0. T3 patients at the diagnosis with 3 or less enlarged nodes, evaluated by imaging, and without evidence of the same nodes after radiochemotherapy, could be accrued according to Center decision, but will be analyzed separately.
- Patients with cT2N0, low located tumour, otherwise candidates to a Miles surgical procedure, treated by neoadjuvant chemoradiation and with written consensus;
- Major clinical response after chemoradiation, yT0-1N0; yT2N0 could be accrued according to Center decision, but will be analyzed separately.
- Circumferential extension less than 2 quarters;
- Deep ulcer < 2 cm of diameter;
- Provision of written informed consent;
- Biopsies are discouraged for the higher risk of following fistulae in irradiated rectum;
Exclusion Criteria:
- pT3;
- Positive margins;
- TRG 3-5;
- Major adverse features: lymphatic vessel invasion, vascular vessel invasion, perineural invasion;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: XELOX-RT
RT: pelvic treatment is the same for both arms: 45 Gy are delivered to the whole pelvis at 1.8 Gy daily, 5 times per week; In the XELOX-RT arm a boost of 5.4 Gy is delivered to the mesorectum corresponding to GTV, at 1.8 Gy daily, in 3 fractions, to a total dose of 50.4 Gy. The boost will be delivered at the end of the irradiation of the pelvis (sequential boost). |
RT: pelvic treatment is the same for both arms: 45 Gy are delivered to the whole pelvis at 1.8 Gy daily, 5 times per week; In the XELOX-RT arm a boost of 5.4 Gy is delivered to the mesorectum corresponding to GTV, at 1.8 Gy daily, in 3 fractions, to a total dose of 50.4 Gy. The boost will be delivered at the end of the irradiation of the pelvis (sequential boost). |
ACTIVE_COMPARATOR: XELAC-RT
Xeloda 1650mg/m2 chronomodulated (h 8.00 a.m. 25% of total dose ; h 6.00 p.m. 25% of total dose; h 11.00 p.m. 50% of total dose) during the whole treatment time. RT: pelvic treatment is the same for both arms: 45 Gy are delivered to the whole pelvis at 1.8 Gy daily, 5 times per week. In the XEL-ACRT arm a boost of 10 Gy is delivered to the mesorectum corresponding to the GTV, at 1 Gy for fraction to a total dose of 55 Gy, in 10 fractions over 5 weeks, 2 times a week. The daily dose of the boost will be delivered twice a week immediately after the daily dose administered to the pelvis (concomitant boost). |
Xeloda 1650mg/m2 chronomodulated (h 8.00 a.m. 25% of total dose ; h 6.00 p.m. 25% of total dose; h 11.00 p.m. 50% of total dose) during the whole treatment time. RT: pelvic treatment is the same for both arms: 45 Gy are delivered to the whole pelvis at 1.8 Gy daily, 5 times per week. In the XEL-ACRT arm a boost of 10 Gy is delivered to the mesorectum corresponding to the GTV, at 1 Gy for fraction to a total dose of 55 Gy, in 10 fractions over 5 weeks, 2 times a week. The daily dose of the boost will be delivered twice a week immediately after the daily dose administered to the pelvis (concomitant boost). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological major downstaging
Time Frame: 15-20 weeks after the randomization
|
INTERACT study: evaluation of T pathological major downstaging, considered as the overall rate of any TRG1 or TRG 2 scored patients; LEADER study (optional): To evaluate the impact on local control of local excision in patients who had a major clinical response, evaluated by EUS/ MRI, yN0 evaluated by multislice CT / MRI, and confirmed by TRG 1-2 score. |
15-20 weeks after the randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor downstaging
Time Frame: 15-20 weeks after the randomization
|
Secondary objectives:
|
15-20 weeks after the randomization
|
sphincter saving surgery
Time Frame: 15-20 weeks after the randomization
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Secondary objectives:
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15-20 weeks after the randomization
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local control
Time Frame: 15-20 weeks after the randomization
|
Secondary objectives:
|
15-20 weeks after the randomization
|
survival
Time Frame: 15-20 weeks after the randomization
|
Secondary objectives:
|
15-20 weeks after the randomization
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 515(A1144)/2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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