Neoplasms

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Colorectal Neoplasms

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Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab.

Following induction treatment regimen (for maintenance treatment): No maintenance treatment.

5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab

Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab.

Following induction treatment regimen (for maintenance treatment): Fluoropyrimidine + Bevacizumab.

Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab.

Following induction treatment regimen (for maintenance treatment): Bevacizumab monotherapy.

Susanna Hegewisch-Becker, Prof. Dr.

Investigating the efficacy of maintenance and reinduction treatment or no treatment and watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy.

The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be compared with a maintenance treatment with bevacizumab alone or no maintenance treatment. Reinduction treatment will be done in case of progression.

Chemotherapy and bevacizumab represent a standard of care in treatment of metastatic colorectal cancer. Until now, continuation of chemotherapy - and bevacizumab - represents the standard of care in colorectal cancer treatment. However, since the OPTIMOX1 trial showed an equivalent duration of disease control for a de-escalation / maintenance / reintroduction strategy compared with a treatment until progression strategy for oxaliplatin-based chemotherapy, the question is whether this strategy might apply also to bevacizumab in combination with chemotherapy. Furthermore, with the introduction of bevacizumab, there are new options for a maintenance treatment which should be evaluated.

As the continuation of chemotherapy plus bevacizumab until disease progression has to be regarded as standard of care, the question is whether a de-escalation of treatment intensity or even withdrawal of treatment ("drug holiday") after a certain treatment period will not be inferior with respect to resulting time with tumor control, but allow patients a period with less toxicity and gain of quality of life.

Optimal Maintenance Therapy With Bevacizumab After Induction in Metastatic Colorectal Cancer (CRC)

Randomized Three Arm Phase III Trial on Induction Treatment With a Fluoropyrimidine-, Oxaliplatin- and Bevacizumab-based Chemotherapy for 24 Weeks Followed by Maintenance Treatment With a Fluoropyrimidine and Bevacizumab vs. Bevacizumab Alone vs. no Maintenance Treatment and Reinduction in Case of Progression for First-line Treatment of Patients With Metastatic Colorectal Cancer

Roche Pharma AG

AIO-Studien-gGmbH

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Gastrointestinal Stromal Tumors

Neoplasm, Residual

Disease Attributes

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

As an one-arm observational clinical trial, we have only one patients cohort.

Zhidong Gao, MD

This study is aimed:

* to evaluate the dynamic monitoring value of MRD detection for postoperative recurrence in high-risk GIST patients;

  * to evaluate the effect of drug holiday mode based on MRD detection on progression-free Survival (PFS) and/or overall survival (OS) after drug withdrawal for high-risk GIST patients who have achieved disease control after long-term use of imatinib; ③ to investigate the response rate of imatinib re-use in patients who developed disease progression after drug withdrawal; ④ to explore whether the "drug holiday" treatment mode based on MRD detection could delay the occurrence of secondary imatinib resistance mutations for high-risk GIST patients with long-term use of imatinib after surgery.

Gastrointestinal stromal tumor (GIST) is the most common mesenchymal tumor of the gastrointestinal tract, and surgery is the preferred treatment method for primary resectable GIST. The guidelines recommend that patients at high risk of recurrence should be treated with tyrosine kinase inhibitors (TKI) such as imatinib for at least 3 years after surgery. However, in actual clinical practice, some patients face the situation of early withdrawal or prolonged medication, so the timing of drug withdrawal needs to be further studied. Recent studies have reported that some GIST patients who have achieved disease control through long-term use of imatinib can still achieve a long progression-free survival after drug withdrawal, and those who relapse after drug withdrawal can still achieve disease control after re-use of imatinib. This suggests that for some selected patients, a "drug holiday" treatment mode could be possible, in which drugs are discontinued when appropriate and restarted if necessary. How to select patients suitable for this mode of treatment needs further exploration. Liquid biopsy of peripheral blood circulating tumor DNA (ctDNA) to detect minimal residual disease (MRD) can be used for the diagnosis, efficacy evaluation, recurrence and drug resistance monitoring of a variety of malignant tumors. Existing studies have explored the "drug holiday" treatment mode based on MRD detection assisting patients with advanced non-small cell lung cancer to use TKI. Therefore, this one-arm prospective observational clinical study will assist some high-risk GIST patients who have been treated with imatinib for 3 years after surgery and have achieved disease control to adopt the treatment mode of "drug holiday" based MRD detection, aiming to evaluate the value of MRD detection in monitoring postoperative recurrence of high-risk GIST, investigate the effect of "drug holiday" treatment mode based on MRD detection on disease recurrence and patient survival, and to explore whether it can delay the occurrence of drug-resistant mutations.

tumor tissues and peripheral blood sample

Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence

Clinical Research of Drug Holiday Based on MRD Detection in Gastrointestinal Stromal Tumor Patients at High Risk of Recurrence

Progression-free survival after patients first enter the drug holiday

The proportion of patients who take drug re-use due to disease progression within 3 years after first entering drug holiday

Drug response rate among patients who take drug re-use due to disease progression within 3 years after first entering drug holiday

Overall survival after patients first enter the drug holiday

Results of genetic mutations in patients after the conversion of MRD from negative to positive, especially the detection of secondary imatinib resistance mutations

compare the time of MRD conversion and the time of disease progression assessed by imaging examination

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optimal Maintenance Therapy With Bevacizumab After Induction in Metastatic Colorectal Cancer (CRC)	NCT00973609	Colorectal Neop...	5-Fluorouracil,... 5-Fluorouracil,... 5-Fluorouracil,...	18 Years -	AIO-Studien-gGmbH
Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence	NCT05867901	Gastrointestina...		18 Years - 75 Years	Peking University People's Hospital

Spots Global Cancer Trial Database for drug holiday

Every month we try and update this database with for drug holiday cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.