A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT02465593|
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : August 31, 2018
This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of PEP503(radio-enhancer).
There are 2 portions in this study.
- Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended injection volume of PEP503 for intratumor injection.
- Expansion phase (Part II): Following the confirmation of the recommended volume of intratumor injection, 18 additional patients will be enrolled at the recommended volume level to evaluate for efficacy.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: PEP503 Drug: 5-fluorouracil Drug: capecitabine Procedure: surgical resection Radiation: Radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of PEP503 (Radioenhancer) With Radiotherapy, in Combination With Concurrent Chemotherapy for Patients With Locally Advanced or Unresectable Rectal Cancer|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
The volume of PEP503 to be administered is based on the baseline tumor volume of each patient. There will be 4 dose levels in Phase Ib.
Other Name: NBTXR3
225 mg/m2 a day, 5 days/week for 5 weeks during radiotherapy period
Other Name: 5-FU
825 mg/m2 BID 5 days/week for 5 weeks during the radiotherapy period
Other Name: Xeloda
Procedure: surgical resection
Approximately 8 weeks after the completion of chemoradiotherapy, surgical resection of the tumor (total mesorectal excision, TME) will be performed once the tumor become resectable.
Intensity-modulated radiation therapy (IMRT) or intensity modulated arc therapy (IMAT) of 5,000 cGy in 25 fractions (200 cGy/fraction, 5 times/week) to gross tumor and involved nodes and 4,500 cGy in 25 fractions (180 cGy/fraction, 5 times/week) to pelvis, starting at 24 hours after PEP503 injection.
- safety profile /the Dose Limiting Toxicity (DLT) [ Time Frame: up to 36 months ]Safety as assess the safety profile and determine the Dose Limiting Toxicity (DLT) of PEP503 given as intratumor injection and activated by external beam radiation, with concurrent chemotherapy in patients with unresectable rectal cancer
- the recommended volume (dose) [ Time Frame: up to 36 months ]recommended volume (dose) of PEP503 examined by given as intratumor injection and activated by external beam radiation. with concurrent chemotherapy in patients with unresectable rectal cancer
- anti-tumor activity [ Time Frame: up to 36 months ]Anti-tumor activity as assessed by response rate (RR, as per RECIST 1.1) of PEP503 at the recommended volume given as intratumor injection and activated by external beam radiation, with concurrent chemotherapy in patients with unresectable rectal cancer
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): NCT02465593
|Contact: Jwa-Yuan Wang, phD||886-7-3121101 ext firstname.lastname@example.org|
|Kaohsiung Medical University Hospital||Recruiting|
|Kaohsiung City, Taiwan|
|Principal Investigator:||Jwa-Yuan Wang, phD||Kaohsiung Municipal United Hospital|