NCT01653301

Preoperative Downstaging of Extraperitoneal T3 Rectal Cancer: XELOXRT Versus XELACRT. A Multicenter, Phase III Study

INTEnsification Radiotherapy With Accelerated Fractionation or ChemoTherapy And Local Excision After 3D External Radio-chemotherapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 616 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	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).
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).

Timeline

• Start date: 2005-10-01
• Primary completion: 2012-12-01
• First posted: 2012-07-31
• Last updated: 2012-07-31

Locations

1 site across 1 country: Italy