Clinical trial · Interventional
A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer
An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer
NCT01274962CI-TRIAL-00078268completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is proposed to evaluate whether giving part of the chemotherapy prior to radiotherapy and surgery (as opposed to standard of care, which involves giving all the chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal cancer will result in higher patient compliance to chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Operable T2-3N+M0 Rectal Cancer (Stage III) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
| high dose rate endorectal brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A - neoadjuvant chemotherapy
- description
- Patients in arm A will receive 6 cycles of FOLFOX chemotherapy prior to radiotherapy and surgery as well as 6 cycles of chemotherapy in adjuvant
- interventionNames
- Drug: FOLFOX
- Radiation: high dose rate endorectal brachytherapy
- type
- EXPERIMENTAL
- label
- Arm B - adjuvant chemotherapy
- description
- Patients in arm B will receive 12 cycles of FOLFOX after radiotherapy and surgery
- interventionNames
- Drug: FOLFOX
- Radiation: high dose rate endorectal brachytherapy
Primary outcomes (1)
- measure
- Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathology: Adenocarcinoma of the rectum. 2. T2 (CRM+) or T3 tumour at ≤ 10 cm from the A-V margin (as per MRI criteria) 3. Evidence of perirectal nodes on MRI or EUS (N1 or N2), any CRM+ and N0 tumor, or any EMVI+ tumor 4. Tumors with an adequate lumen to allow the positioning of the Oncosmart intracavitary mould applicator (e.g. non obstructive tumor). 5. Tumour of less than 3.5 cm thickness documented at the CT Simulator. 6. Patient should be a suitable candidate for surgery and chemotherapy. 7. WHO performance status 0-2 8. Age \> 18 years. 9. Written informed consent. 10. Adequate birth control measures in women with childbearing potential. Exclusion Criteria: 1. Patients with positive extramesorectal or pelvic nodes (e.g. iliac, lateral). 2. Evidence of distant metastases (M1). 3. Previous pelvic radiation. 4. Other cancers except for basal cell carcinoma of the skin or CIS of the cervix. 5. Presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy). 6. Extension of malignant disease to the anal canal 7. Patients with severe co-morbid conditions (recent MI, infections, AIDS, etc) 8. Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.