Neoadjuvant Treatment With Regorafenib and Capecitabine Combined With Radiotherapy in Locally Advanced Rectal Cancer (RECAP)
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|ClinicalTrials.gov Identifier: NCT02910843|
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: Regorafenib Drug: Capecitabine Radiation: Radiotherapy Procedure: Surgery||Phase 1|
Despite treatment of locally advanced rectal cancer relapses are frequent. Several attempts to improve these results with therapy intensification have shown modest effect on disease free survival (DFS) and overall survival (OS). Recent studies with addition of sorafenib and cediranib revealed promising effect on tumor response with acceptable toxicity. Regorafenib is a multi tyrosine kinase inhibitor (TKI) with a broad mechanism of action. Therefore this trial investigates if similar results can be achieved as with sorafenib or cediranib.
The objective of the dose escalation part is to determinate safety, tolerability and the recommended dose. The objective of the expansion cohort is to assess the efficacy and to further characterize safety and tolerability of the therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Treatment With Regorafenib and Capecitabine Combined With Radiotherapy in Locally Advanced Rectal Cancer. A Multicenter Phase Ib Trial (RECAP)|
|Actual Study Start Date :||February 22, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2022|
Experimental: Regorafenib & Capecitabine
Other Name: BAY 73-4506
• Capecitabine: day 1 to 38 (5 weeks and 3 days, including Saturday and Sunday) according to dose escalation table. The intake stops in the evening of the last day of RT.
Other Name: XELODA
Monday through Friday for 5 weeks and 3 days (d1-38) starting on day 1 (daily fraction 1.8 Gy, final dose 50.4 Gy).
6-12 weeks (± 1 week) after radio-chemotherapy (RCT) has been completed (42-84 days after last day of RCT).
- Dose limiting toxicity (DLTs) [ Time Frame: up to 4 weeks after the last administration of RCT ]In the dose escalation part the dose limiting toxicity (DLTs) is observed during and up to 4 weeks after the last administration of RCT.
- Pathological near complete or complete tumor response (npCR or pCR) [ Time Frame: up to 2 months after end of treatment ]In the dose escalation part the pathological near complete or complete tumor response (npCR or pCR) is specified.
- Quality of the mesorectal excision including details of the circumferential resection margin (CRM)/surface [ Time Frame: up to 2 months after end of treatment ]Quality of the mesorectal excision including details of the circumferential resection margin (CRM)/surface according to Nagtegaal.
- Sphincter preservation [ Time Frame: up to 2 months after end of treatment ]Sphincter preservation is defined as preservation of the rectal sphincter or part of it.
- Pathological response [ Time Frame: up to 2 months after end of treatment ]Dworak tumor regression grading (TRG) system.
- Circumferential resection margin (CRM) status [ Time Frame: up to 2 months after end of treatment ]
Negative (clear) circumferential margins are defined by an invasion front which is at a > 1mm distance from the lateral resection margin; circumferential resection margins of ≤ 1 mm are considered positive (involved).
CRM negative (clear) ≤ 1mm and CRM positive (involved) ≤ 1mm.
- Downstaging of primary tumor and/or lymph nodes (comparison between mrT/N and ypT/N) [ Time Frame: up to 2 months after end of treatment ]Downstaging of primary tumor and/or lymph nodes (comparison between mrT/N and ypT/N)
- Postoperative complications [ Time Frame: within 8 weeks after surgery ]
Surgical complications within 8 weeks after surgery. A surgical local complication is defined as either:
- insufficiency of anastomosis
- severe local infection requiring antibiotics
- bladder dysfunction
- erectile dysfunction
- additional interventions / operation needed (e.g. drainage of hematoma/abscess)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910843
|Contact: Daniela Bärtschi||+41 31 389 91 firstname.lastname@example.org|
|St. Claraspital Basel||Recruiting|
|Basel, Switzerland, 4016|
|Contact: Dieter Köberle, MD +41 61 685 85 85 email@example.com|
|Principal Investigator: Dieter Köberle, MD|
|Basel, Switzerland, 4031|
|Contact: Viviane Hess, Prof +41 61 265 50 74 firstname.lastname@example.org|
|Principal Investigator: Viviane Hess, Prof|
|Bern, Switzerland, 3010|
|Contact: Martin D. Berger, MD +41 31 632 41 14 email@example.com|
|Principal Investigator: Martin D. Berger, MD|
|Chur, Switzerland, 7000|
|Contact: Ioannis Metaxas, MD +41 81 256 66 46 firstname.lastname@example.org|
|Principal Investigator: Ioannis Metaxas, MD|
|Luzern, Switzerland, 6000|
|Contact: Ralph Winterhalder, MD +41 41 205 58 75 email@example.com|
|Principal Investigator: Ralph Winterhalder, MD|
|Kantonsspital St. Gallen||Withdrawn|
|St. Gallen, Switzerland, 9007|
|Zurich, Switzerland, 8091|
|Contact: Bernhard Pestalozzi, Prof +41 (0)44 255 34 40 firstname.lastname@example.org|
|Principal Investigator: Bernhard Pestalozzi, Prof|
|Study Chair:||Sara Bastian, MD||Kantonsspital Graubünden, Chur|