A Phase 2 interventional study of VMAT-SIB and XELOX in Rectal Neoplasms, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Phase 2, Interventional, and Treatment
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).
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 18 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
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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.
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.
Radiation: VMAT-SIB · Drug: XELOX
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.
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.
Also known as: Oxaliplatin + Capecitabine
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%.
Time frame: 6-8 weeks after chemoradiotherapy
Acute Toxicity
To score acute toxicity CTCAE v.3.0 was used
Time frame: During radiation treatment and at the first follow-up visit (4 weeks after RT).
No study locations are listed for this record.
Plan to share: Yes — International Journals
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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IRCCS Azienda Ospedaliero-Universitaria di Bologna