An interventional study of Dedicated and coordinated follow-up and Standard follow-up in Metastatic Solid Tumor, sponsored by Institut Claudius Regaud. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-31.
Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Health services research
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Among 542 studies in Neoplasm Metastasis with a site in France — 93 open to participants now, 165 under way, 50 of them phase 3. Neoplasm Metastasis · France.
Among the 542 studies in Neoplasm Metastasis with a site in France, this one is the 207th largest by enrollment of the 477 interventional ones that give a count, is one of 21 that started in 2017, is one of 62 with no phase, and was the 285th registered.
4,045 studies on the registry are indexed under Neoplasm Metastasis; 888 are open to participants now.
Browse Neoplasm Metastasis studies →93 of the 542 studies in Neoplasm Metastasis with a site in France are open now. Recruiting first, the newest first:
UNICANCER · Sites in France
Ages 12+
Centre Georges Francois Leclerc · Sites in France
Ages 18+
Mark C Burgmans, MD PhD · Sites in France, Netherlands
Ages 18+
AstraZeneca · Sites in France, United States, Germany and 6 more countries
Ages 18–130
Regeneron Pharmaceuticals · Sites in France, United States, Australia and 3 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 689 Neoplasm Metastasis studies recruiting now, 536 (78%) set no upper age limit and 97 (14%) stop at 75 or younger; 48 take children under 18; 18 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
542 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 123 · Phase 2 218 · Phase 3 138 · Phase 4 6
First in 1990; this study’s year is marked. 21 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 186 is above the median of 50 across 3,270 interventional studies indexed under Neoplasm Metastasis.
Median enrollment 133 across the 477 interventional studies, 120 across the 59 observational. Of the 338 that completed or were terminated, 134 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
293 of 542 have an industry lead sponsor. The 10 most frequent:
Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 33 are open to participants now.
Institut Claudius Regaud has 4 studies filed under Neoplasm Metastasis — fewer than ten, so there is no comparison to draw.
42 of the studies in Neoplasm Metastasis with a site in France that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06506955Phase 3Taiho Oncology, Inc.Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. | 2027-04 |
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
| NCT06103864Phase 3AstraZenecaA Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05) | 2027-07-28 |
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT01442246Phase 3UNICANCEREvaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients. | 2027-09 |
Add all 42 to your calendar (.ics) → With an account.
Among the 542 studies in Neoplasm Metastasis with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, comparative, open label, randomized, multicentric study evaluating the benefit of a dedicated and coordinated follow-up on treatment adherence in patients with metastatic solid tumor and starting a first cycle of treatment compared to standard follow-up. A dedicated and coordinated follow-up during the treatment period will be based on a telephone follow-up and a pharmaceutical conciliation.
Patients will be randomized into one of two study arms:
Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a pharmaceutical conciliation made by the Center Pharmacist.
Arm B: Standard follow-up during the treatment period.
Patients will be followed during 6 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Dedicated and coordinated follow-up
Standard
Other: Standard follow-up
* Coordinated follow-up performed by a dedicated nurse with consultations (before treatment initiation and during treatment) and a telephone follow-up during treatment period * Pharmaceutical conciliation before treatment initiation made by the Center Pharmacist * Completion of QLQ-C30 and GIRERD questionnaires
- Completion of QLQ-C30 and GIRERD questionnaires
Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.
This outcome will be assessed by the counting of tablets and the completion of the GIRERD questionnaire by the patient (assessment performed at 1, 3 and 6 months during the treatment)
Time frame: 6 months per patient
Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation
Time frame: 6 months per patient
Quality of life using the QLQ-C30 questionnaire
Time frame: 6 months per patient
Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
Time frame: 6 months per patient
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Jan 2022, 54 months.
Of 291 non-industry interventional studies with no phase under Neoplasm Metastasis, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 93. This study's 54 months is close to that.
Counting every sponsor, half of 316 studies reached it within 54 months; a quarter within 28 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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