NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer (NEOLAR)
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|ClinicalTrials.gov Identifier: NCT03280407|
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 28, 2017
The main clinical hypothesis is that compared to radio-chemotherapy for low and mid rectal tumors or surgery for high rectal tumors neoadjuvant chemotherapy reduces the rate of distant relapse without increasing the rate of local relapse.
The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery Furthermore, early surgical and medical complications, the functional outcome, toxicity and quality of life (QoL) may be improved if radiotherapy can be avoided.
Exploratory analyses are planned in order to find potential predictive markers for selecting patients to either radio-chemotherapy/surgery or neoadjuvant combination chemotherapy/surgery.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasm Colorectal Cancer Rectal Neoplasms Chemotherapy Effect Intestinal Disease Intestinal Neoplasms Rectal Cancer||Drug: Capecitabine Drug: FOLFOX regimen (oxaliplatin/leucovorin/5FU) Drug: CAPOX (oxaliplatin/capecitabine)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an open label, randomized phase II screening trial allocating eligible patients to either standard treatment for rectal cancer or experimental preoperative combination chemotherapy.|
|Masking:||None (Open Label)|
|Official Title:||NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer: a Randomized Phase II Trial|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2024|
Active Comparator: A, capecitabine
Radiochemotherapy with 50.4 Gy in 28 fractions concomitantly with chemotherapy
Radio-chemotherapy with 50.4 Gy in 28 fractions to tumor and regional lymph nodes concomitantly with capecitabine 825 mg/m2 b.i.d
Experimental: B, FOLFOX or CAPOX
Neoadjuvant chemotherapy with CAPOX (oxaliplatin/capecitabine) or FOLFOX regimen (oxaliplatin/leucovorin/5FU), according to institutional practice
Drug: FOLFOX regimen (oxaliplatin/leucovorin/5FU)
Six cycles: Oxaliplatin 85 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1 and 5FU 2400 mg/ m2 over 46-48 hours day 1-3, repeated every two weeks.
Other Name: FOLFOX (oxaliplatin/leucovorin/5FU)
Drug: CAPOX (oxaliplatin/capecitabine)
Four cycles: Oxaliplatin 130 mg/m2 day 1 and capecitabine 1000 mg/m2 b.i.d. days 1-14, repeated every 3 weeks.
- Disease free survival [ Time Frame: 5 years ]All patients will be evaluated with CT and MRI scans and clinically every 6 months for 2 years and annually until the number of events is reached and the trial is stopped (max 5 years)
- Overall survival [ Time Frame: 5 years ]All patients will be evaluated with CT and MRI scans and clinically every 6 months for 2 years and annually for maximum 5 years
- Local relapse [ Time Frame: 5 years ]Defined to be within the pelvis. Any relapse should be verified by biopsy
- Distant relapse [ Time Frame: 5 years ]Defined to be outside the pelvis. Any relapse should be verified by biopsy
- Early toxicity [ Time Frame: 5 years ]Evaluated using CTCEA (Common Terminology Criteria for Adverse Events) version 4.
- Late toxicity [ Time Frame: 5 years ]Evaluated using CTCEA version 4.
- Functional outcome [ Time Frame: 5 years ]Measured with LARS questionnaire
- Quality of life (QoL) [ Time Frame: 5 years ]Measured with EORTC QoL questionnaire
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): NCT03280407
|Contact: Ismail Gögenur, MD||+45 firstname.lastname@example.org|
|Contact: Lars Henrik Jensen, MD|
|Contact: Lars Henrik Jensen, MD PhD email@example.com|
|Study Chair:||Ismail Gögenur, MD||Department of Surgery, ZUH|
|Principal Investigator:||Lars Henrik Jensen, MD||Vejle Hospital|