Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer.
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|ClinicalTrials.gov Identifier: NCT01814969|
Recruitment Status : Unknown
Verified May 2015 by Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was: Recruiting
First Posted : March 20, 2013
Last Update Posted : May 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Radiation: Hyperfractionated Radiochemotherapy Radiation: Hyperfractionated Radiotherapy||Phase 3|
Overview of randomized trials conducted in patients with advanced colorectal cancer with the use of preoperative radiotherapy or radiochemotherapy clearly shows the superiority of combined therapy over surgery alone. In these studies documented a significant reduction in tumor mass as a result of preoperative radiotherapy or radiochemotherapy theoretically increases the chance of performing operations with sphincters preservation, even in cases originally eligible for abdomino - perineal resection. There is the question whether the combination of preoperative hyperfractionated radiotherapy and concurrent chemotherapy may cause the further improvement of treatment outcome in patients with locally advanced rectal cancer. Published in 2012 by Gerard et al. meta-analysis of randomized trials dedicated to the treatment of patients with advanced colorectal cancer, confirms a higher percentage of sphincters preservation in patients operated after more than 5-week interval between neoadjuvant therapy and surgery.
Analysis of these issues will be taken in the current study. Comparison of the two treatment regimens as preoperative phase III study with stratification for time interval between the end of radiotherapy or radiochemotherapy and surgery may show differences that have not been seen in previously published data.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Hyperfractionated Radiotherapy Versus Combined Radiochemotherapy for Patients With Locally Advanced Rectal Cancer: a Phase III Randomized Trial.|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2018|
Experimental: Hyperfractionated Radiochemotherapy
radiotherapy in rectal tumor area due to the placing of pelvic nodal groups to a total dose of 42 Gy, 1.5 Gy d fx 2 times a day; (gap between the factions min. 6-8h) - duration of treatment 2.5 weeks with simultaneous two cycles of chemotherapy according to the scheme: 5FU-325mg/m2 (bolus) on 1-3 and 16-18 (last 3 days of radiotherapy).
Surgical resection has to be done within 14 days or 5-6 weeks after the completion of hyperfractionated radiochemotherapy (HRTCT).
Radiation: Hyperfractionated Radiochemotherapy
28 x 1.5Gy 2 times a day; gap between the fractions min. 6-8h - duration of treatment 2.5 weeks + simultaneous bolus 5-Fluorouracil (the each cycle consisted of 5-fluorouracil 325 mg/m2 per day) on 1-3 and 16-18 (last 3 days of radiotherapy).
Other Name: Hyperfractionated Radiochemotherapy (HRTCT)
Active Comparator: Hyperfractionated Radiotherapy
radiotherapy in rectal tumor area due to the placing of pelvic nodal groups to a total dose of 42 Gy, 1.5 Gy d fx 2 times a day; (gap between the factions min. 6-8h) - duration of treatment 2.5 weeks.
Surgical resection has to be done within 14 days or 5-6 weeks after the completion of hyperfractionated radiotherapy (HRT).
Radiation: Hyperfractionated Radiotherapy
28 x 1.5Gy 2 times a day; gap between the factions min. 6-8h - duration of treatment 2.5 weeks
Other Name: Hyperfractionated Radiotherapy (HRT)
- • The rate of patients with downstaging after radiotherapy or radiochemotherapy to pathological response or disease with negative margins [ Time Frame: Surrogate endpoint available immediatly after surgery ]
- The rate of local failures [ Time Frame: 3 years ]
- Progression-free long-term survival [ Time Frame: 3 years ]
- The rate of distant metastases [ Time Frame: 3 years ]
- Overall long-term survival [ Time Frame: 3 years ]
- The rate of late toxicity according to the RTOG/EORTC scale [ Time Frame: 3 years ]
- The rate of postoperative complications [ Time Frame: 3 months ]
- The rate of early toxicity of neoadjuvant treatment according to the NCI CTCAE (version 4.0) [ Time Frame: 3 months ]
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): NCT01814969
|Contact: Adam Idasiak, MDemail@example.com|
|Contact: Rafal Suwinski, MDfirstname.lastname@example.org|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch||Recruiting|
|Gliwice, Wybrzeze AK 15, Poland, 44-100|
|Contact: Adam Idasiak, MD +48322788819 email@example.com|
|Principal Investigator: Rafal Suwinski, MD, PhD|
|Principal Investigator:||Rafal Suwinski, MD||Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland|