Advanced Soft-tissue SarcomaPhase 3GERICO14NCT04757337
Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients
A Phase 3 study testing Doxorubicin and Cyclophosphamide in people with Advanced Soft-tissue Sarcoma and Metastatic Soft-tissue Sarcoma, run by UNICANCER at 1 site in France.
Trial summary
Most advanced or metastatic soft tissue sarcoma (STS) are unfortunately incurable, making the preservation of the patient's quality of life a major goal, along with prolonging survival. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma
- What is being tested?
- Doxorubicin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2021to Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trust person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent
- Age ≥65 years (inclusions will be managed to ensure that at least 50% of the randomized patients are ≥75 years old)
- Diagnosis of soft-tissue sarcoma histologically confirmed by Réseau de Référence en Pathologie des Sarcomes et des Viscères (RRePS)
- Metastatic or locally advanced disease not amenable to surgery, radiation, or combined modality treatment with curative intent. Palliative radiation therapy is permitted only if direct on nontarget lesion
- Documentation of disease progression within the last 6 months before randomization
- Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT-scan as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
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- Life expectancy of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- G8 score >14
- Left ventricular ejection fraction (LVEF) value by echocardiogram or Multiple gated acquisition scanning (MUGA) ≥55%
- Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:
- Absolute neutrophil count (ANC) ≥1,500/mm³
- Platelets ≥100,000/mm³
- Hemoglobin ≥9.0 g/dL
- Serum creatinine ≤2 x upper limit of normal (ULN)
- Glomerular filtration rate (GFR) ≥50 ml/min/1.73m² (calculated with MDRD)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5.0 × ULN for patients with liver involvement of their cancer )
- Total bilirubin ≤1.5 X ULN
- Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)
- serum albumin >25 g/L
- Prothrombin time (PT)/International normalized ratio (INR) ≤1.5 x ULN Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until PT/INR is stable based on a measurement that is pre-dose as defined by the local standard of care
- Male patients must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment/therapy. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care
- Patients must be affiliated to a Social Security System (or equivalent)
- Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures including follow-up
Who cannot join
- Previous systemic treatment for advance or metastatic sarcoma
- Previous neoadjuvant or adjuvant anthracycline treatment for localized sarcoma
- Soft-tissue sarcoma with the following histological subtypes: dermatofibrosarcoma protuberans, desmoid tumor, alveolar or embryonal rhabdomyosarcoma, Desmoplastic small round cell tumor, Kaposi Sarcoma, Gastro-Intestinal stromal tumor, Peripheral neuroectodermal tumors
- Primary bone sarcoma (including osteosarcoma, Ewing tumor, chondrosarcoma, and chordoma)
- Symptomatic or known central nervous system (CNS) metastases
- Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator and history of radiotherapy mediastinal in the last five years
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- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before Day 1 of treatment
- Active cardio vascular disease including any of the following: Congestive heart failure (New York Heart Association (NYHA) ≥Class 2), unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), acute inflammatory cardiopathy, severe arrythmia, high risk of bleeding, cerebrovascular accident within the last 6 months
- Uncontrolled grade >2 hypertension. (Systolic blood pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite optimal medical management)
- Ongoing infection ≥Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
- Known history of human immunodeficiency virus (HIV) infection
- Known history of chronic hepatitis B or C
- History of organ allograft
- Pre-existing acute hemorrhagic cystitis, urinary tract obstruction, acute urinary tract infection
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Substance abuse, medical condition, that may interfere with the patient's participation in the study or evaluation of the study results
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
- Inability to swallow oral medications, any malabsorption condition.
- Persons deprived of their liberty or under protective custody or guardianship
- Participation in another therapeutic trial within the 30 days prior to randomization and during the study
- Patients having received live attenuated vaccine therapy used for prevention of diseases as influenza, chickenpox, zoster, measles, mumps, rubella, tuberculosis, rotavirus or yellow fever within 4 weeks of the first dose of study drug. These vaccinations are not permitted during the study up to 6 months after the last treatment
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
Trial locations and contacts
1 site in 1 country.
Meryem Brihoum contact
France1 site, 1 recruiting
- Recruiting
Institut Claudius Reagaud-IUCT Oncopôle
Toulouse, 31100
Thibaud Valentin, MD, +33 5 31 15 51 70, Valentin.Thibaud@iuct-oncopole.fr
About this study
Official title: Randomized Phase III Study of Oral Cyclophosphamide vs Doxorubicin in 65 Years or Older Patients With Advanced or Metastatic Soft Tissue Sarcoma: a UNICANCER/GERICO Multicenter Program
Most advanced or metastatic soft tissue sarcoma (STS) are unfortunately incurable, making the preservation of the patient's quality of life a major goal, along with prolonging survival.
Age is not a criterion for not providing effective treatment, but the goals of treatment change with age and must be integrated into the treatment decision. Elderly patients prioritise a life free of dependency, preservation of their cognitive functions and quality of life related to their state of health. They are therefore reluctant to receive a treatment that does little to improve life expectancy at the cost of significant functional losses.
Read more
Patients aged 65 years and older account for one third of all patients with STS. In the absence of dedicated recommendations, these elderly patients are currently receiving doxorubicin-based chemotherapy as first-line treatment (as recommended for younger patients), with a substantial risk of toxicity (especially cardiac). In this specific population, previous studies have shown that oral cyclophosphamide seems to have a promising activity, but also a very acceptable toxicity.
Thus, the GERICO study aims to compare standard doxorubicin chemotherapy with oral cyclophosphamide for the treatment of elderly patients with STS.
Read the detailed description
Co-morbidities increase in number and severity with age, competing with cancer prognosis and making prioritizing medical issues necessary. Individualization of cancer treatment by integrating a comprehensive geriatric assessment (CGA) is frequently considered as essential and mandatory for elderly cancer patients. The G8 questionnaire is able to identify patients requiring CGA, with a threshold score of ≤14/17 and with a strong 1-year prognostic value.
According to guidelines, the recommended first-line treatment of these patients relies on single agent chemotherapy with anthracyclines (including doxorubicin); however, anthracycline-based treatments have modest performance in patients with metastatic STS with a median progression-free survival of about 4 months and an overall survival of about 12 months.
Previous studies have demonstrated promising activity of oral metronomic cyclophosphamide in STS patients and its favorable safety profile.
To evaluate this promising activity we designed a phase III, randomized, open-label, multicentric study comparing daily oral cyclophosphamide versus standard 3-week intravenous injection of doxorubicin in 65 years or older patients with advanced or metastatic STS.
- Being tested
- Doxorubicin, Cyclophosphamide
- Keywords
- Elderly, older patients, oral cyclophosphamide, doxorubicin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
6 x 3-week cycles corresponding to a maximal duration of 18 weeks
CyclophosphamideDrug
Also called Endoxan®
Until progression up to 24 months
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicin | Active comparator | Intravenous Doxorubicin 60 mg/m² Cycle 1 then 75 mg/m² Cycle 2 to Cycle 6 D1-D21 with granulocyte-colony stimulating factor (G-CSF) and dexrazoxane. Receives: Drug: Doxorubicin |
| Cyclophosphamide | Experimental | Cyclophosphamide per os 100 mg twice a day, 1 week on, 1 week off until 2 years, or unacceptable toxicity, disease progression, withdrawn of consent or death. Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Measured: From randomization to disease progression or death, up to 2 years.
Secondary outcomes (7)
Overall survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Measured: From randomization to death from any cause, up to 2 years
Best response under treatment
Best response under treatment: Best response (as per RECIST v1.1) recorded from the date of randomization until the end of treatment. Each patient will be assigned one of the following categories: complete response, partial response, stable disease, disease progression, or unevaluable for response (specify reasons, e.g. early death, malignant disease; toxicity; tumor assessment not repeated/incomplete; other). Responses will have to be confirmed at least 4 weeks after the evaluation to exclude measurement errors.
Measured: From randomization to progression, death or new treatment, up to 2 years.
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline, week 9, week 18, 3 months, 6 months, 9 months, 12 months, 15 month, 18 month, and 24 months
Quality of life questionnaire - Elderly cancer patients (QLQ-ELD14)
The EORTC QLQ-ELD14, a validated HRQOL questionnaire for cancer patients aged greater than or equal to70 years, is intended to supplement the QLQ-C30.
The QLQ-ELD14 contains 14 items incorporating five scales to assess mobility, worries about others, future worries, maintaining purpose, and illness burden. In addition, two single items assess joint stiffness and family support. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. High scores indicate poor mobility, good family support, much worry about the future, good maintenance of autonomy and purpose, and high burden of illness.
Measured: At baseline, week 9, week 18, 3 months, 6 months, 9 months, 12 months, 15 month, 18 month, and 24 months
Assessment of the toxicity profile of oral cyclophosphamide and doxorubicin, as per NCI CTCAE v5.0
Toxicity: Adverse events will be graded according to the CTCAE v5.0.
Measured: From randomization to progression, death or new treatment, up to 2 years.
Geriatric assessment
The Geriatric Core Dataset (G-CODE) was developed by the DIalog for personALization of management in geriatric OncoloGy (DIALOG) intergroup to assess the general health status of the older patient.
The G-Code contains 10 tools incorporating seven scales to assess social environment, functional status, mobility, nutritional status, cognitive status, depressive mood, and comorbidities. The total scale range 0-62. High score indicate better condition.
Measured: At baseline
Assessment of compliance to oral metronomic cyclophosphamide (Cyclophosphamide Arm only)
Compliance to oral metronomic cyclophosphamide will be assessed based on data reported by the patients (patient diary).
Measured: From randomization to the end of treatment, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start18 Jun 2021
- Primary completionJul 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Soft-tissue SarcomaStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibaud Valentin, M.D, Principal investigator, Institut Claudius Regaud-IUCT Oncopôle ToulouseOlivier Mir, M.D, Principal investigator, Gustave Roussy Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757337
- Sponsor's protocol ID
- UC-0103/1802
- Other IDs
- 2018-000542-20, 2018
- Acronym
- GERICO14
- Status last verified
- Jun 2024
- First submitted
- 10 Feb 2021
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study of Oral Cyclophosphamide vs Doxorubicin in 65 Years or Older Patients With Advanced or Metastatic Soft Tissue Sarcoma: a UNICANCER/GERICO Multicenter Program
- ClinicalTrials.gov ID
- NCT04757337
- Acronym / sponsor ID
- GERICO14 / UC-0103/1802
- Keywords
- Elderly, older patients, oral cyclophosphamide, doxorubicin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most advanced or metastatic soft tissue sarcoma (STS) are unfortunately incurable, making the preservation of the patient's quality of life a major goal, along with prolonging survival.
Age is not a criterion for not providing effective treatment, but the goals of treatment change with age and must be integrated into the treatment decision. Elderly patients prioritise a life free of dependency, preservation of their cognitive functions and quality of life related to their state of health. They are therefore reluctant to receive a treatment that does little to improve life expectancy at the cost of significant functional losses.
Patients aged 65 years and older account for one third of all patients with STS. In the absence of dedicated recommendations, these elderly patients are currently receiving doxorubicin-based chemotherapy as first-line treatment (as recommended for younger patients), with a substantial risk of toxicity (especially cardiac). In this specific population, previous studies have shown that oral cyclophosphamide seems to have a promising activity, but also a very acceptable toxicity.
Thus, the GERICO study aims to compare standard doxorubicin chemotherapy with oral cyclophosphamide for the treatment of elderly patients with STS.
Detailed description
Co-morbidities increase in number and severity with age, competing with cancer prognosis and making prioritizing medical issues necessary. Individualization of cancer treatment by integrating a comprehensive geriatric assessment (CGA) is frequently considered as essential and mandatory for elderly cancer patients. The G8 questionnaire is able to identify patients requiring CGA, with a threshold score of ≤14/17 and with a strong 1-year prognostic value.
According to guidelines, the recommended first-line treatment of these patients relies on single agent chemotherapy with anthracyclines (including doxorubicin); however, anthracycline-based treatments have modest performance in patients with metastatic STS with a median progression-free survival of about 4 months and an overall survival of about 12 months.
Previous studies have demonstrated promising activity of oral metronomic cyclophosphamide in STS patients and its favorable safety profile.
To evaluate this promising activity we designed a phase III, randomized, open-label, multicentric study comparing daily oral cyclophosphamide versus standard 3-week intravenous injection of doxorubicin in 65 years or older patients with advanced or metastatic STS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin | Active comparator | Drug: DoxorubicinIntravenous Doxorubicin 60 mg/m² Cycle 1 then 75 mg/m² Cycle 2 to Cycle 6 D1-D21 with granulocyte-colony stimulating factor (G-CSF) and dexrazoxane. |
| Cyclophosphamide | Experimental | Drug: CyclophosphamideCyclophosphamide per os 100 mg twice a day, 1 week on, 1 week off until 2 years, or unacceptable toxicity, disease progression, withdrawn of consent or death. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (24 listed)
- Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trust person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent
- Age ≥65 years (inclusions will be managed to ensure that at least 50% of the randomized patients are ≥75 years old)
- Diagnosis of soft-tissue sarcoma histologically confirmed by Réseau de Référence en Pathologie des Sarcomes et des Viscères (RRePS)
- Metastatic or locally advanced disease not amenable to surgery, radiation, or combined modality treatment with curative intent. Palliative radiation therapy is permitted only if direct on nontarget lesion
- Documentation of disease progression within the last 6 months before randomization
Key exclusion criteria (22 listed)
- Previous systemic treatment for advance or metastatic sarcoma
- Previous neoadjuvant or adjuvant anthracycline treatment for localized sarcoma
- Soft-tissue sarcoma with the following histological subtypes: dermatofibrosarcoma protuberans, desmoid tumor, alveolar or embryonal rhabdomyosarcoma, Desmoplastic small round cell tumor, Kaposi Sarcoma, Gastro-Intestinal stromal tumor, Peripheral neuroectodermal tumors
- Primary bone sarcoma (including osteosarcoma, Ewing tumor, chondrosarcoma, and chordoma)
- Symptomatic or known central nervous system (CNS) metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxorubicin6 x 3-week cycles corresponding to a maximal duration of 18 weeks | Drug | Doxorubicin |
| CyclophosphamideAlso: Endoxan®Until progression up to 24 months | Drug | Cyclophosphamide |
Primary outcome
Progression-free survival (PFS)
Time frame: From randomization to disease progression or death, up to 2 years.
The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
7 secondary outcomes
Overall survival (OS)
Time frame: From randomization to death from any cause, up to 2 years
Best response under treatment
Time frame: From randomization to progression, death or new treatment, up to 2 years.
Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At baseline, week 9, week 18, 3 months, 6 months, 9 months, 12 months, 15 month, 18 month, and 24 months
Quality of life questionnaire - Elderly cancer patients (QLQ-ELD14)
Time frame: At baseline, week 9, week 18, 3 months, 6 months, 9 months, 12 months, 15 month, 18 month, and 24 months
Assessment of the toxicity profile of oral cyclophosphamide and doxorubicin, as per NCI CTCAE v5.0
Time frame: From randomization to progression, death or new treatment, up to 2 years.
Geriatric assessment
Time frame: At baseline
Assessment of compliance to oral metronomic cyclophosphamide (Cyclophosphamide Arm only)
Time frame: From randomization to the end of treatment, up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem Brihoum contact
Thibaud Valentin, M.D principal investigator
Institut Claudius Regaud-IUCT Oncopôle Toulouse
Olivier Mir, M.D principal investigator
Gustave Roussy Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxorubicin and Cyclophosphamide in people with Advanced Soft-tissue Sarcoma and Metastatic Soft-tissue Sarcoma, run by UNICANCER at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thibaud Valentin, M.D (+33 5 31 15 51 70, Valentin.Thibaud@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From randomization to disease progression or death, up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.