Rectal NeoplasmsPhase 2GRACENCT02745639
Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer
A Phase 2 study testing VMAT-SIB and XELOX in people with Rectal Neoplasms, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial summary
This was a prospective phase II study on patients with locally advanced rectal cancer or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- VMAT-SIB and XELOX
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Nov 2015
- Phase
- Phase 2
- 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
Inclusion Criteria: i) histologically proven rectal adenocarcinoma (cT3-4N0-2 or cT2N1-2 or locally recurrent) beginning within 12 cm from the anal verge; ii) age ≥ 18 years; iii) Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion Criteria: i) history of chemotherapy and/or pelvic radiotherapy; ii) previous treatment with immunotherapy; iii) metastatic patient; iv) presence of active intestinal inflammation or uncontrolled pelvic inflammation; v) pregnant and/or breastfeeding patient.
About this study
Official title: Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer: a Phase II Study.
This was a prospective phase II study on patients with locally advanced rectal cancer or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).
Read the detailed description
This was a prospective phase II study on patients with LARC or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).
The primary aim was to asses the pathological response rate. Key secondary aim was the acute toxicity. Secondary aims were local control, disease-free survival (DFS) and overall survival (OS).
The follow-up period of each subjects started at the end of combined treatment and concluded after a period of maximum 60 months or until death.
- Conditions
- Rectal Neoplasms
- Being tested
- VMAT-SIB, XELOX
- Keywords
- rectal cancer, radiotherapy, chemotherapy, VMAT, toxicity
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMAT-SIBRadiation
Radiation dose prescribed to PTV2 was 45 Gy (1.8 Gy/fraction), five sessions weekly in 25 daily fractions. A simultaneous boost was delivered on PTV1 with a total dose of 57.5 Gy (2.3 Gy/fraction). Dose-volume histograms (DVHs) were calculated for the PTV1, PTV2 and OARs. Patients were treated only if the relative variations of the bone markers between the images were within 3 mm along the three spatial directions. Planning and delivery processes underwent to systematic independent-check procedures.
XELOXDrug
Also called Oxaliplatin + Capecitabine
The prescribed concurrent chemotherapy consisted of oxaliplatin infusion 130 mg/m2 on days 1, 17, 35 and capecitabine 1650 mg/m2 daily (825 mg/m² twice daily, 5 days/week) over all the treatment. An adequate blood count was necessary to start each chemotherapy infusion. Adjuvant chemotherapy was recommended on patients with high risk factors at pathological examination and decision was left to medical oncologists discretion.
| Study group | Role | What they receive |
|---|---|---|
| VMAT-SIB + XELOX | Experimental | A VMAT-SIB technique was used. Radiation dose prescribed to PTV2 was 45 Gy (1.8 Gy/fraction), five sessions weekly in 25 daily fractions. A simultaneous boost was delivered on PTV1 with a total dose of 57.5 Gy (2.3 Gy/fraction). Dose-volume histograms (DVHs) were calculated for the PTV1, PTV2 and Organs at risks.
The prescribed concurrent chemotherapy consisted of oxaliplatin infusion 130 mg/m2 on days 1, 17, 35 and capecitabine 1650 mg/m2 daily (825 mg/m² twice daily, 5 days/week) over all the treatment. Receives: Radiation: VMAT-SIB; Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response rate
Pathological response was determined according to the TNM classification system of the American Joint Committee on Cancer. The complete resection of the tumor (R) with no histological proven residual disease in the surgical specimen, was defined as pathological complete response (pCR =pT0). Near complete response (pTmic) was defined as the presence of a number of neoplastic cells inferior to 10%.
Measured: 6-8 weeks after chemoradiotherapy
Secondary outcomes (1)
Acute Toxicity
To score acute toxicity CTCAE v.3.0 was used
Measured: During radiation treatment and at the first follow-up visit (4 weeks after RT).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startFeb 2010
- Primary completionNov 2013
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Fuccio, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Alessio G Morganti, Professor, Study director, Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745639
- Sponsor's protocol ID
- GRACE-RECTUM-1
- Acronym
- GRACE
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: International Journals
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer: a Phase II Study.
- ClinicalTrials.gov ID
- NCT02745639
- Acronym / sponsor ID
- GRACE / GRACE-RECTUM-1
- Conditions
- Rectal Neoplasms
- Keywords
- rectal cancer, radiotherapy, chemotherapy, VMAT, toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Apr 2016 (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.
This was a prospective phase II study on patients with locally advanced rectal cancer or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).
Detailed description
This was a prospective phase II study on patients with LARC or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).
The primary aim was to asses the pathological response rate. Key secondary aim was the acute toxicity. Secondary aims were local control, disease-free survival (DFS) and overall survival (OS).
The follow-up period of each subjects started at the end of combined treatment and concluded after a period of maximum 60 months or until death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VMAT-SIB + XELOX | Experimental | Radiation: VMAT-SIB, Drug: XELOXA VMAT-SIB technique was used. Radiation dose prescribed to PTV2 was 45 Gy (1.8 Gy/fraction), five sessions weekly in 25 daily fractions. A simultaneous boost was delivered on PTV1 with a total dose of 57.5 Gy (2.3 Gy/fraction). Dose-volume histograms (DVHs) were calculated for the PTV1, PTV2 and Organs at risks. The prescribed concurrent chemotherapy consisted of oxaliplatin infusion 130 mg/m2 on days 1, 17, 35 and capecitabine 1650 mg/m2 daily (825 mg/m² twice daily, 5 days/week) over all the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| VMAT-SIBRadiation dose prescribed to PTV2 was 45 Gy (1.8 Gy/fraction), five sessions weekly in 25 daily fractions. A simultaneous boost was delivered on PTV1 with a total dose of 57.5 Gy (2.3 Gy/fraction). Dose-volume histograms (DVHs) were calculated for the PTV1, PTV2 and OARs. Patients were treated only if the relative variations of the bone markers between the images were within 3 mm along the three spatial directions. Planning and delivery processes underwent to systematic independent-check procedures. | Radiation | VMAT-SIB + XELOX |
| XELOXAlso: Oxaliplatin + CapecitabineThe prescribed concurrent chemotherapy consisted of oxaliplatin infusion 130 mg/m2 on days 1, 17, 35 and capecitabine 1650 mg/m2 daily (825 mg/m² twice daily, 5 days/week) over all the treatment. An adequate blood count was necessary to start each chemotherapy infusion. Adjuvant chemotherapy was recommended on patients with high risk factors at pathological examination and decision was left to medical oncologists discretion. | Drug | VMAT-SIB + XELOX |
Primary outcome
Pathological response rate
Time frame: 6-8 weeks after chemoradiotherapy
Pathological response was determined according to the TNM classification system of the American Joint Committee on Cancer. The complete resection of the tumor (R) with no histological proven residual disease in the surgical specimen, was defined as pathological complete response (pCR =pT0). Near complete response (pTmic) was defined as the presence of a number of neoplastic cells inferior to 10%.
1 secondary outcome
Acute Toxicity
Time frame: During radiation treatment and at the first follow-up visit (4 weeks after RT).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Individual participant dataSharing planned: Yes. International Journals
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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.
Alessio G Morganti, Professor study director
Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VMAT-SIB and XELOX in people with Rectal Neoplasms, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response rate (time frame: 6-8 weeks after chemoradiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2016.