Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749108
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2021-02-05
Brief Title:
Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
Official Title:
Multicentric Phase II-III Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma After a Favorable Response to Induction Chemotherapy
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRECCAR14
Brief Summary:
Locally advanced rectal carcinoma raise the issue of both the oncological control local and general and the therapeutic morbidity Surgery alone can cure only one out of two patients radiochemotherapy improves the local control but the metastatic risk remains about 30 with enhanced postoperative morbidity and poor functional results The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor To this day there are no biologic predictive markers for tumor response
The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy MRI volumetric tumor response will be used to distinguish between good responders and bad responders
Very good responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery Standard arm Cap 50
The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy MRI volumetric tumor response will be used to distinguish between good responders and bad responders
Very good responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery Standard arm Cap 50
Detailed Description:
Cancer of the rectum is a common disease It affects nearly 15000 new people each year with more men 53 than women 47
In more than 9 out of 10 cases it occurs after 50 years Three types of treatments are used to treat rectal cancer surgery radiotherapy and drug treatments
The standard treatment for Locally Advanced Rectal Cancers LARC is multidisciplinary combining chemotherapy radiotherapy and surgery The usual treatment in this situation is called induction chemotherapy administrated before radiochemotherapy This phase of treatment taking place before surgery is called neoadjuvant therapy
However treating all cancers of the locally advanced rectum with the same neoadjuvant treatment exposes patients who are good responders to neoadjuvant chemotherapy with possible toxicity to radiotherapy and patients who are poor responders to ineffectiveness of conventional radiotherapy with surgery and so to a mutilating ineffective treatment
The short- and long-term toxicity of pelvic radiation may be the most compelling reason to reconsider reflexive neoadjuvant radiochemotherapy NA-RCT and to move toward a more individualized approach
A large North American trial is currently evaluating the suppression of preoperative radiation therapy in patients selected as a good responder to induction chemotherapy
A first trial called GRECCAR-4 Surgical Research Group on Rectum CAncer with induction chemotherapy by 5 Fluorouracil Irinotecan Oxaliplatin and personalized radiochemotherapy reported the following results
High-dose induction chemotherapy is well tolerated and reproducible
Early assessment after neo-adjuvant chemotherapy makes it possible to discriminate between good and bad responders without a negative impact on surgery
Personalized management of LARC according to the early tumor response to chemotherapy is possible
In good responder patients a resection rate of 100 was achieved even in the arm without radiotherapy but due to poor recruitment it is not possible to draw a formal conclusion regarding these promising results
The oncological results at 5 years show a local recurrence rate of 0 for the good responders and 48 for the poor responders The 5-year overall survival was 867 with a 5-year progression-free survival of 750
GRECCAR 14 is the only French trial to question the feasibility of appropriate management of non-metastatic LARC Its main objective is to evaluate in good responder patients personalized management after preoperative CT treatment
GRECCAR-14 will try to confirm this strategy taking into account the 1st results of GRECCAR 4
The study will initially focus on 200 patients to assess the surgical quality of this therapeutic strategy and then on 230 additional patients to assess the effectiveness of this personalized treatment on survival without recurrence
In more than 9 out of 10 cases it occurs after 50 years Three types of treatments are used to treat rectal cancer surgery radiotherapy and drug treatments
The standard treatment for Locally Advanced Rectal Cancers LARC is multidisciplinary combining chemotherapy radiotherapy and surgery The usual treatment in this situation is called induction chemotherapy administrated before radiochemotherapy This phase of treatment taking place before surgery is called neoadjuvant therapy
However treating all cancers of the locally advanced rectum with the same neoadjuvant treatment exposes patients who are good responders to neoadjuvant chemotherapy with possible toxicity to radiotherapy and patients who are poor responders to ineffectiveness of conventional radiotherapy with surgery and so to a mutilating ineffective treatment
The short- and long-term toxicity of pelvic radiation may be the most compelling reason to reconsider reflexive neoadjuvant radiochemotherapy NA-RCT and to move toward a more individualized approach
A large North American trial is currently evaluating the suppression of preoperative radiation therapy in patients selected as a good responder to induction chemotherapy
A first trial called GRECCAR-4 Surgical Research Group on Rectum CAncer with induction chemotherapy by 5 Fluorouracil Irinotecan Oxaliplatin and personalized radiochemotherapy reported the following results
High-dose induction chemotherapy is well tolerated and reproducible
Early assessment after neo-adjuvant chemotherapy makes it possible to discriminate between good and bad responders without a negative impact on surgery
Personalized management of LARC according to the early tumor response to chemotherapy is possible
In good responder patients a resection rate of 100 was achieved even in the arm without radiotherapy but due to poor recruitment it is not possible to draw a formal conclusion regarding these promising results
The oncological results at 5 years show a local recurrence rate of 0 for the good responders and 48 for the poor responders The 5-year overall survival was 867 with a 5-year progression-free survival of 750
GRECCAR 14 is the only French trial to question the feasibility of appropriate management of non-metastatic LARC Its main objective is to evaluate in good responder patients personalized management after preoperative CT treatment
GRECCAR-14 will try to confirm this strategy taking into account the 1st results of GRECCAR 4
The study will initially focus on 200 patients to assess the surgical quality of this therapeutic strategy and then on 230 additional patients to assess the effectiveness of this personalized treatment on survival without recurrence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-000414-41 | EUDRACT_NUMBER | None | None |