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New treatment option for Colonic Adenocarcinoma
Official title Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over
ClinicalTrials.gov ID: NCT02355379
What this study is testing
What is LV5FU2 or capectitabine?
LV5FU2 or capectitabine is an investigational medicine, being studied as a potential treatment for colonic adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- Age ≥ 70 years
- Patient considered able to receive chemotherapy
- Lee score detailed faxed to CRGA
- Stage III colon adenocarcinoma
- R0 resection of the primary tumor
You likely can't join if
- Other progressive disease (cancer uncontrolled for less than 2 years)
- Rectal Cancer (located less than 15 cm from the anal verge endoscopy or sub-peritoneal)
- ANC \<2000 / mm3 for group 1 and ANC \<1500 / mm3 for group 2 and platelets \<100,000 / mm3 or hemoglobin \<9 g / dL
- Neuropathy for patients in group 1
- Known deficit of dihydropyrimidine dehydrogenase (DPD)
- Patients with severe hepatic insufficiency
See the full eligibility criteria
- Age ≥ 70 years
- Patient considered able to receive chemotherapy
- Lee score detailed faxed to CRGA
- Stage III colon adenocarcinoma
- R0 resection of the primary tumor
- Start of the potential adjuvant chemotherapy within 12 weeks after surgery
- No prior chemotherapy for colon cancer
- Geriatric Self-administered questionnaire completed faxed to CRGA
- Geriatric Questionnaire completed by the team faxed to CRGA
- Effective contraception for men patients throughout treatment and for at least 6 months after discontinuation of oxaliplatin
- Consent signed
- Other progressive disease (cancer uncontrolled for less than 2 years)
- Rectal Cancer (located less than 15 cm from the anal verge endoscopy or sub-peritoneal)
- ANC \<2000 / mm3 for group 1 and ANC \<1500 / mm3 for group 2 and platelets \<100,000 / mm3 or hemoglobin \<9 g / dL
- Neuropathy for patients in group 1
- Known deficit of dihydropyrimidine dehydrogenase (DPD)
- Patients with severe hepatic insufficiency
- Any contrindication to the drugs used in the study
- Inability to submit to medical follow-up for geographical, social or psychological reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Fort de France, Guadeloupe, France
- Abbeville, France
- Agen, France
- Aix-en-Provence, France
- Albi, France
- Alès, France
- Amiens, France
- Angers, France
- Annemasse, France
- Argenteuil, France
- Arras, France
- Aubenas, France
- Auxerre, France
- Avignon, France
- Bayeux, France
- Bayonne, France
- Beauvais, France
- Béziers, France
- Blois, France
- Bobigny, France
+ 86 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort de France, Guadeloupe, France; Abbeville, France; Agen, France; Aix-en-Provence, France; Albi, France; Alès, France and 100 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.