Rectal CancerPhase 3INTERACTNCT01653301
Preoperative Downstaging of Extraperitoneal T3 Rectal Cancer: XELOXRT Versus XELACRT. A Multicenter, Phase III Study
A Phase 3 study testing XELAC RT and XELOX RT in people with Rectal Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
INTERACT study: to evaluate the pathological response rate in cT3 rectal cancer LEADER study: to evaluate the impact on local control of local excision Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- XELAC RT and XELOX RT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2005to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- WBC > 4,000 cells/ml, platelets > 100,000 cells/ml.
- Provision of written informed consent.
- 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;
Who cannot join
- 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.
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- 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
- pT3;
- Positive margins;
- TRG 3-5;
- Major adverse features: lymphatic vessel invasion, vascular vessel invasion, perineural invasion;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Catholic University of Sacred Heart
Rome, Italy, 00168
Vincenzo Valentini, MD, +390630155226, vvalentini@rm.unicatt.it
Vincenzo Valentini, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- XELAC RT, XELOX RT
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XELAC RTDrug
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).
XELOX RTDrug
- Xeloda: 1300 mg/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;
- Oxaliplatin: 130mg/m2, days 1, 19, 38
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).
| Study group | Role | What they receive |
|---|---|---|
| XELOX-RT | Experimental | * Xeloda: 1300 mg/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;
* Oxaliplatin: 130mg/m2, days 1, 19, 38
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). Receives: Drug: XELOX RT |
| XELAC-RT | Active comparator | 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). Receives: Drug: XELAC RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological major downstaging
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.
Measured: 15-20 weeks after the randomization
Secondary outcomes (4)
Tumor downstaging
Secondary objectives:
- Tumour downstaging, evaluated by the comparison of clinical staging before combined modality treatment toward pathological staging.
- feasibility of a sphincter saving surgical procedure;
- evaluation of activity of preoperative treatment (clinical response, facultative)
- post-surgical functional outcome;
- evaluation of the local control of the disease;
- estimates (Kaplan-Meier, product limit method) of the disease free survival;
- Evaluation of adverse events and adverse reactions to treatment, according to both the RTOG and NCI-CTC criteria.
Measured: 15-20 weeks after the randomization
sphincter saving surgery
Secondary objectives:
- Tumour downstaging, evaluated by the comparison of clinical staging before combined modality treatment toward pathological staging.
- feasibility of a sphincter saving surgical procedure;
- evaluation of activity of preoperative treatment (clinical response, facultative)
- post-surgical functional outcome;
- evaluation of the local control of the disease;
- estimates (Kaplan-Meier, product limit method) of the disease free survival;
- Evaluation of adverse events and adverse reactions to treatment, according to both the RTOG and NCI-CTC criteria.
Measured: 15-20 weeks after the randomization
local control
Secondary objectives:
- Tumour downstaging, evaluated by the comparison of clinical staging before combined modality treatment toward pathological staging.
- feasibility of a sphincter saving surgical procedure;
- evaluation of activity of preoperative treatment (clinical response, facultative)
- post-surgical functional outcome;
- evaluation of the local control of the disease;
- estimates (Kaplan-Meier, product limit method) of the disease free survival;
- Evaluation of adverse events and adverse reactions to treatment, according to both the RTOG and NCI-CTC criteria.
Measured: 15-20 weeks after the randomization
survival
Secondary objectives:
- Tumour downstaging, evaluated by the comparison of clinical staging before combined modality treatment toward pathological staging.
- feasibility of a sphincter saving surgical procedure;
- evaluation of activity of preoperative treatment (clinical response, facultative)
- post-surgical functional outcome;
- evaluation of the local control of the disease;
- estimates (Kaplan-Meier, product limit method) of the disease free survival;
- Evaluation of adverse events and adverse reactions to treatment, according to both the RTOG and NCI-CTC criteria.
Measured: 15-20 weeks after the randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startOct 2005
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Valentini, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653301
- Sponsor's protocol ID
- 515(A1144)/2005
- Acronym
- INTERACT
- Status last verified
- Jul 2012
- First submitted
- 30 Apr 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Valentini V, Gambacorta MA, Cellini F, Aristei C, Coco C, Barbaro B, Alfieri S, D'Ugo D, Persiani R, Deodato F, Crucitti A, Lupattelli M, Mantello G, Navarria F, Belluco C, Buonadonna A, Boso C, Lonardi S, Caravatta L, Barba MC, Vecchio FM, Maranzano E, Genovesi D, Doglietto GB, Morganti AG, La Torre G, Pucciarelli S, De Paoli A. The INTERACT Trial: Long-term results of a randomised trial on preoperative capecitabine-based radiochemotherapy intensified by concomitant boost or oxaliplatin, for cT2 (distal)-cT3 rectal cancer. Radiother Oncol. 2019 May;134:110-118. doi: 10.1016/j.radonc.2018.11.023. Epub 2019 Feb 7.
PubMed 31005204
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTEnsification Radiotherapy With Accelerated Fractionation or ChemoTherapy And Local Excision After 3D External Radio-chemotherapy
- ClinicalTrials.gov ID
- NCT01653301
- Acronym / sponsor ID
- INTERACT / 515(A1144)/2005
- Conditions
- Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2012 (estimated)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- INTERACT study: to evaluate the pathological response rate in cT3 rectal cancer
- LEADER study: to evaluate the impact on local control of local excision
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XELOX-RT | Experimental | Drug: XELOX RT* Xeloda: 1300 mg/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; * Oxaliplatin: 130mg/m2, days 1, 19, 38 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). |
| XELAC-RT | Active comparator | Drug: XELAC RTXeloda 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XELAC RTXeloda 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). | Drug | XELAC-RT |
| XELOX RT* Xeloda: 1300 mg/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; * Oxaliplatin: 130mg/m2, days 1, 19, 38 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). | Drug | XELOX-RT |
Primary outcome
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.
4 secondary outcomes
Tumor downstaging
Time frame: 15-20 weeks after the randomization
sphincter saving surgery
Time frame: 15-20 weeks after the randomization
local control
Time frame: 15-20 weeks after the randomization
survival
Time frame: 15-20 weeks after the randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Derived from this study: PubMed 31005204Valentini V, Gambacorta MA, Cellini F, Aristei C, Coco C, Barbaro B, Alfieri S, D'Ugo D, Persiani R, Deodato F, Crucitti A, Lupattelli M, Mantello G, Navarria F, Belluco C, Buonadonna A, Boso C, Lonardi S, Caravatta L, Barba MC, Vecchio FM, Maranzano E, Genovesi D, Doglietto GB, Morganti AG, La Torre G, Pucciarelli S, De Paoli A. The INTERACT Trial: Long-term results of a randomised trial on preoperative capecitabine-based radiochemotherapy intensified by concomitant boost or oxaliplatin, for cT2 (distal)-cT3 rectal cancer. Radiother Oncol. 2019 May;134:110-118. doi: 10.1016/j.radonc.2018.11.023. Epub 2019 Feb 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XELAC RT and XELOX RT in people with Rectal Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Valentini, MD (+390630155226, vvalentini@rm.unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological major downstaging (time frame: 15-20 weeks after the randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01653301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2012.