Understanding chronic toxicities in localized cancer treatments
A Prospective Cohort to Investigate Survivorship Issues in Patients With Early Cancer
This study is trying to understand the long-term side effects of cancer treatments in women with early-stage breast and lung cancer to see how they affect their lives and find ways to improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14750 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Unicancer Academic / other |
| Drugs / interventions | Pembrozilumab, chemotherapy, radiation |
| Locations | 1 site (Villejuif) |
| Trial ID | NCT01993498 on ClinicalTrials.gov |
What this trial studies
This study aims to quantify the impact of treatment-related chronic toxicities in women with non-metastatic breast cancer and early lung cancer. It will develop a comprehensive database to track these toxicities, describe their incidence and outcomes, and assess their psychological, social, and economic impacts. The study will also generate predictors for chronic toxicities based on biological criteria, with a focus on improving patient quality of life. A total of 14,750 women will be recruited across 26 cancer centers in France and followed for at least five years.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and over with stage I-III non-metastatic breast cancer who are untreated at the time of inclusion.
Not a fit: Patients with metastatic breast cancer or those who have received prior treatment for breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients by identifying and preventing chronic toxicities associated with cancer treatments.
How similar studies have performed: Other studies have shown success in identifying treatment-related toxicities, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
CANTO - Breast Inclusion Criteria: * Women, * Aged 18 years and over, * With an invasive breast cancer diagnosed by cytology or histology, * No clinical evidence of metastasis at the time of inclusion, * Untreated including scored for breast cancer surgery in progress, * Patient receiving a social security system, * Patient mastering the French language, * Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage. * (Since february 2022) Patient : 1. Age \< 45 years at diagnostic 2. Or CT2-3, cN0-3, HER2+(RH+or RH-) or RH-HER2- 3. Or Eligible to Pembrozilumab, Olaparib, TDM1, Abemaciclib or Ribociclib Exclusion Criteria: * Metastatic breast cancer, * Local recurrence of breast cancer, * History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix, * Already received treatment for breast cancer ongoing, * Blood transfusion performed for less than six months, * Persons deprived of liberty or under supervision (including guardianship). CANTO - Lung Inclusion Criteria: * Aged 18 years and over, Having lung cancer diagnosed by cytology or histology or suspected cancer of the lung, * Tumor cTX to cT4, cN0-3, * No clinical evidence of metastasis at the time of inclusion (patients with metastases on extension assessment within 6 months following diagnosis will be removed from the study), * Eligible for curative treatment by surgery or radiotherapy \* (note patients treated with exclusive chemotherapy, exclusive radiotherapy or exclusive stereotactic radiotherapy will be out of study) * Lack of treatment received for current lung cancer, including surgical treatment * Patient benefiting from a social protection scheme, * Patient mastering the French language, * Free and informed consent for additional biological samples, the different questionnaires and the collection of information on resource consumption. Exclusion Criteria: * Metastatic lung cancer, * Local relapse of lung cancer, * History of cancer within 3 years prior to study entry other than basal cell cutaneous or epithelioma in situ of the cervix, * Treatment already received for current lung cancer, * Blood transfusion carried out less than 6 months ago, * Persons deprived of liberty or under guardianship (including curatorship).
Where this trial is running
Villejuif
- Gustave roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Catherine Gaudin
- Email: c-gaudin@unicancer.fr
- Phone: (0)6 71 48 27 76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.