Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT02723253|
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rectal Neoplasms||Radiation: Radiotherapy Drug: Tom-OX||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer: A Phase II Study.|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||February 2012|
Experimental: Radiotherapy plus Tom-Ox
Patients received concomitant boost RT (55 Gy/5 weeks) with concurrent Tom-Ox chemotherapy. The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.
Radiotherapy was applied as conformal 3-D technique and was delivered with photon energies of 10 - 15 MV. The beams were delivered by an Elekta Precise Linac equipped with standard multi leaf collimators (MLC). A daily online check of isocenter position was performed using portal imaging, with set-up correction in case of displacement > 0.5 cm in any direction. Radiation dose delivered to PTV2 was 45 Gy (1.8 Gy/fraction) with a concomitant boost dose to the PTV1 of 10 Gy with accelerated fractionation at 2.2 Gy/fraction, five consecutive days for week.
The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.
Other Name: Tomudex ®, Eloxatin ®
- Number of patients defined as good responders (G1 or G2) according to the Mandard regression grading system. [ Time Frame: 8 weeks after chemo-radiotherapy ]Pathologic responses of the primary tumours were defined according to the Mandard regression grading system: grade 1 was recorded when no tumour cells remained in the primary tumour and lymph nodes (pCR); grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis; grade 3 was characterized by an increase in the number of residual cancer cells, but fibrosis still predominated; grade 4 showed residual cancer outgrowing fibrosis; and grade 5 was characterized by an absence of regressive changes. Good responders were defined those patients with a pathologic response with Mandard G1 or G2 and poor responder patients with Mandard G3, G4 or G5.
- Number of patients in which a surgical resection was feasible [ Time Frame: 8 weeks after chemo-radiotherapy ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 [ Time Frame: Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death. ]CTCAE v 3.0 was used to score acute and late radiation toxicity.
- The number of patients without disease (i.e. rectal cancer) during the follow-up. [ Time Frame: Up to 36 months. ]The disease-free survival (DFS) was defined as the time from the diagnosis to the documented local or distant recurrence or last follow-up.
- The number of patients still alive at the end of follow-up [ Time Frame: Up to 36 months ]The overall-survival (OS) was defined as the time from the diagnosis until death for any cause or the last follow-up.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723253
|Study Director:||Alessio G Morganti, Prof||Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy|